Complicated Urinary Tract InfectionPhase 3NCT01644643
Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
A Phase 3 study testing Ceftazidime - Avibactam ( CAZ-AVI), Best Available Therapy and Metronidazole in people with Complicated Urinary Tract Infection and Complicated Intra-abdominal Infection, run by Pfizer at 43 sites in 18 countries.
Trial summary
To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Complicated Urinary Tract Infection, Complicated Intra-abdominal Infection
- What is being tested?
- Ceftazidime - Avibactam ( CAZ-AVI), Best Available Therapy and Metronidazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 43 sitesin 18 countries
- Study dates
- Jan 2013to Sep 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be ≥18 and ≤90 years of age
- Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
- Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection
Who cannot join
- Patient has an APACHE II score >30 (cIAI patients only)
- Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised
- Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.
Trial locations and contacts
43 sites in 18 countries.
43 sites in 18 countries
Bulgaria6 sites
Research Site
Pazardzhik
Research Site
Pleven
Research Site
Rousse
Research Site
Sofia
Research Site
Varna
Research Site
Veliko Tarnovo
Russia6 sites
Research Site
Irkutsk
Research Site
Krasnodar
Research Site
Novosibirsk
Research Site
Penza
Research Site
Saint Petersburg
Research Site
Yaroslavl
Israel4 sites
Research Site
Nazareth
Research Site
Petah Tikva
Research Site
Ramat Gan
Research Site
Tel Aviv
Turkey (Türkiye)4 sites
Research Site
Ankara
Research Site
Antalya
Research Site
Diyarbakır
Research Site
Istanbul
Ukraine4 sites
Research Site
Dnipropetrovsk
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Zaporizhzhya
United States2 sites
Research Site
Lima, Ohio
Research Site
Shreveport, Louisiana
About this study
Official title: An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.
Read the detailed description
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
- Being tested
- Ceftazidime - Avibactam ( CAZ-AVI), Best Available Therapy, Metronidazole
- Keywords
- Ceftazidime,, avibactam,, metronidazone,, Anti-Infectives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftazidime - Avibactam ( CAZ-AVI)Drug
Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
Best Available TherapyDrug
Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation
MetronidazoleDrug
Also called Flagyl
Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion
| Study group | Role | What they receive |
|---|---|---|
| Ceftazidime - Avibactam ( CAZ-AVI) | Experimental | IV treatment Receives: Drug: Ceftazidime - Avibactam ( CAZ-AVI); Drug: Metronidazole |
| Best Available Therapy | Active comparator | IV treatment Receives: Drug: Best Available Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set
Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Secondary outcomes (37)
Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.
Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set
Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set
Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.
Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Clinical Response at TOC in EME at TOC Analysis Set.
Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Clinical Response at FU1 in EME at FU1 Analysis Set.
Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Clinical Response at FU2 in EME at FU2 Analysis Set
Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.
Measured: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set
Proportion of patients with clinical cure at TOC visit by baseline pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set
Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set
Proportion of patients with clinical cure at TOC visit by previously failed treatment class in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set
Proportion of patients with clinical cure at EOT visit by previously failed treatment class in EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: 28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set
Proportion of patients with clinical cure at TOC visit by previously failed treatment class in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set
Proportion of patients with clinical cure at FU1 visit by previously failed treatment class in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Measured: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set
Proportion of patients with clinical cure at FU2 visit by previously failed treatment class in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.
Measured: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-patient Microbiological Response at EOT in mMITT Analysis Set
Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Measured: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-patient Microbiological Response at TOC in mMITT Analysis Set
Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Measured: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-patient Microbiological Response at FU1 in mMITT Analysis Set
Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Measured: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization
Per-patient Microbiological Response at FU2 in mMITT Analysis Set
Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Measured: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-patient Microbiological Response at EOT in EME at EOT Analysis Set
Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Measured: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-patient Microbiological Response at TOC in EME at TOC Analysis Set
Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Measured: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set
Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Measured: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization
Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set
Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Measured: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Measured: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Measured: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Measured: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Measured: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Measured: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Measured: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Measured: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Measured: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, 32, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.
Measured: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.
Measured: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
The Reason for Treatment Change/Discontinuation in mMITT Analysis Set
Proportion of patients in the mMITT analysis set for whom the assigned study treatment was changed, discontinued, or interrupted. Creatinine clearance (CrCl)
Measured: From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.
The 28 Days All Cause Mortality Rate in mMITT Analysis Set
Proportion of patients with Day 28 all-cause mortality in mMITT analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.
Measured: From first infusion to Day 28
The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set
Proportion of patients with Day 28 all-cause mortality in EME at TOC analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.
Measured: From first infusion to Day 28
Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set
Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.
Measured: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug
Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set
Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.
Measured: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Complicated Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Paul Newell, MBBS, MRCP, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644643
- Sponsor's protocol ID
- D4280C00006
- Other IDs
- 2012-000726-21
- Status last verified
- Aug 2017
- First submitted
- 28 Jun 2012
- Last updated
- 29 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Carmeli Y, Armstrong J, Laud PJ, Newell P, Stone G, Wardman A, Gasink LB. Ceftazidime-avibactam or best available therapy in patients with ceftazidime-resistant Enterobacteriaceae and Pseudomonas aeruginosa complicated urinary tract infections or complicated intra-abdominal infections (REPRISE): a randomised, pathogen-directed, phase 3 study. Lancet Infect Dis. 2016 Jun;16(6):661-673. doi: 10.1016/S1473-3099(16)30004-4. Epub 2016 Apr 20.
PubMed 27107460Torres A, Wible M, Tawadrous M, Irani P, Stone GG, Quintana A, Debabov D, Burroughs M, Bradford PA, Kollef M. Efficacy and safety of ceftazidime/avibactam in patients with infections caused by beta-lactamase-producing Gram-negative pathogens: a pooled analysis from the Phase 3 clinical trial programme. J Antimicrob Chemother. 2023 Nov 6;78(11):2672-2682. doi: 10.1093/jac/dkad280.
PubMed 37700689Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.
PubMed 32602065Mendes RE, Castanheira M, Woosley LN, Stone GG, Bradford PA, Flamm RK. Characterization of beta-Lactamase Content of Ceftazidime-Resistant Pathogens Recovered during the Pathogen-Directed Phase 3 REPRISE Trial for Ceftazidime-Avibactam: Correlation of Efficacy against beta-Lactamase Producers. Antimicrob Agents Chemother. 2019 May 24;63(6):e02655-18. doi: 10.1128/AAC.02655-18. Print 2019 Jun.
PubMed 30910899Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
PubMed 30221827Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
PubMed 30061279Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.
PubMed 29912399Stone GG, Bradford PA, Newell P, Wardman A. In Vitro Activity of Ceftazidime-Avibactam against Isolates in a Phase 3 Open-Label Clinical Trial for Complicated Intra-Abdominal and Urinary Tract Infections Caused by Ceftazidime-Nonsusceptible Gram-Negative Pathogens. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01820-16. doi: 10.1128/AAC.01820-16. Print 2017 Feb.
PubMed 27872067
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
- ClinicalTrials.gov ID
- NCT01644643
- Acronym / sponsor ID
- D4280C00006
- Keywords
- Ceftazidime,, avibactam,, metronidazone,, Anti-Infectives
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Posted 14 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.
Detailed description
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftazidime - Avibactam ( CAZ-AVI) | Experimental | Drug: Ceftazidime - Avibactam ( CAZ-AVI), Drug: MetronidazoleIV treatment |
| Best Available Therapy | Active comparator | Drug: Best Available TherapyIV treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must be ≥18 and ≤90 years of age
- Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
- Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection
Key exclusion criteria (4 listed)
- Patient has an APACHE II score >30 (cIAI patients only)
- Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised
- Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftazidime - Avibactam ( CAZ-AVI)Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes | Drug | Ceftazidime - Avibactam ( CAZ-AVI) |
| Best Available TherapyPatients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation | Drug | Best Available Therapy |
| MetronidazoleAlso: FlagylAnti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion | Drug | Ceftazidime - Avibactam ( CAZ-AVI) |
Primary outcome
Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
37 secondary outcomes
Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Clinical Response at TOC in EME at TOC Analysis Set.
Time frame: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Clinical Response at FU1 in EME at FU1 Analysis Set.
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Clinical Response at FU2 in EME at FU2 Analysis Set
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set
Time frame: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set
Time frame: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set
Time frame: 28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-patient Microbiological Response at EOT in mMITT Analysis Set
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-patient Microbiological Response at TOC in mMITT Analysis Set
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-patient Microbiological Response at FU1 in mMITT Analysis Set
Time frame: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization
Per-patient Microbiological Response at FU2 in mMITT Analysis Set
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-patient Microbiological Response at EOT in EME at EOT Analysis Set
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-patient Microbiological Response at TOC in EME at TOC Analysis Set
Time frame: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set
Time frame: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization
Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
The Reason for Treatment Change/Discontinuation in mMITT Analysis Set
Time frame: From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.
The 28 Days All Cause Mortality Rate in mMITT Analysis Set
Time frame: From first infusion to Day 28
The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set
Time frame: From first infusion to Day 28
Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set
Time frame: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug
Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set
Time frame: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27107460Carmeli Y, Armstrong J, Laud PJ, Newell P, Stone G, Wardman A, Gasink LB. Ceftazidime-avibactam or best available therapy in patients with ceftazidime-resistant Enterobacteriaceae and Pseudomonas aeruginosa complicated urinary tract infections or complicated intra-abdominal infections (REPRISE): a randomised, pathogen-directed, phase 3 study. Lancet Infect Dis. 2016 Jun;16(6):661-673. doi: 10.1016/S1473-3099(16)30004-4. Epub 2016 Apr 20.
- Derived from this study: PubMed 37700689Torres A, Wible M, Tawadrous M, Irani P, Stone GG, Quintana A, Debabov D, Burroughs M, Bradford PA, Kollef M. Efficacy and safety of ceftazidime/avibactam in patients with infections caused by beta-lactamase-producing Gram-negative pathogens: a pooled analysis from the Phase 3 clinical trial programme. J Antimicrob Chemother. 2023 Nov 6;78(11):2672-2682. doi: 10.1093/jac/dkad280.
- Derived from this study: PubMed 32602065Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.
- Derived from this study: PubMed 30910899Mendes RE, Castanheira M, Woosley LN, Stone GG, Bradford PA, Flamm RK. Characterization of beta-Lactamase Content of Ceftazidime-Resistant Pathogens Recovered during the Pathogen-Directed Phase 3 REPRISE Trial for Ceftazidime-Avibactam: Correlation of Efficacy against beta-Lactamase Producers. Antimicrob Agents Chemother. 2019 May 24;63(6):e02655-18. doi: 10.1128/AAC.02655-18. Print 2019 Jun.
- Derived from this study: PubMed 30221827Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
- Derived from this study: PubMed 30061279Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
- Derived from this study: PubMed 29912399Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.
- Derived from this study: PubMed 27872067Stone GG, Bradford PA, Newell P, Wardman A. In Vitro Activity of Ceftazidime-Avibactam against Isolates in a Phase 3 Open-Label Clinical Trial for Complicated Intra-Abdominal and Urinary Tract Infections Caused by Ceftazidime-Nonsusceptible Gram-Negative Pathogens. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01820-16. doi: 10.1128/AAC.01820-16. Print 2017 Feb.
Related trials for Complicated Urinary Tract Infection
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
RecruitingPhase 4
Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
Complicated Urinary Tract Infection, Infection
RecruitingPhase 2
A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
Gram Negative Infections
Not yet recruitingPhase 2
This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis
Complicated Urinary Tract Infections(cUTI), Acute Pyelonephritis
Active, not recruitingPhase 2
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Acute Pyelonephritis, Complicated Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Newell, MBBS, MRCP study director
AstraZeneca
43 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceftazidime - Avibactam ( CAZ-AVI), Best Available Therapy and Metronidazole in people with Complicated Urinary Tract Infection and Complicated Intra-abdominal Infection, run by Pfizer at 43 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Bulgaria, Russia, Israel, Turkey (Türkiye), Ukraine and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set (time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644643, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.