Urinary Tract InfectionsPhase 4CAPITISNCT03891433
Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic UTI Due to -ESBL-producing Enterobacteriaceae
A Phase 4 study testing Meropenem, Ertapenem 1000 MG and Piperacillin, Tazobactam 4-0.5G Solution for Injection in people with Urinary Tract Infections and Enterobacteriaceae Infections, run by Universidad del Norte at 1 site in Colombia.
Trial summary
This study evaluates the efficacy in achieving clinical cure in non-bacteremic urinary tract infections (UTI) caused by Escherichia coli or Klebsiella pneumoniae producers of extended-spectrum β-lactamases (ESBL) in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Enterobacteriaceae Infections, Infection Due to ESBL Bacteria
- What is being tested?
- Meropenem, Ertapenem 1000 MG and Piperacillin, Tazobactam 4-0.5G Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteColombia
- Study dates
- 1 Apr 2019to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with hospital admission for non-bacteremic UTI caused by E. coli or K. pneumoniae ESBL susceptible to piperacillin/tazobactam and carbapenems.
- Presence of any risk factor associated with UTI due to ESBL germs: older age 64 years, diabetes mellitus, bladder catheter, previous antibiotics in the last 6 months, hospitalization in the last 6 months, urological surgery in the last 30 days, infections recurrent urinary.
- Diagnosis of UTI confirmed by: 1) fever, 2) urine culture> 100000 CFU with isolation E. coli or K. pneumoniae ESBL susceptible to piperacillin / tazobactam and carbapenems, and 3) lumbar and / or abdominal pain with or without low urinary symptoms (dysuria, tenesmus, urgency), and 4) no other cause that explains the patient's symptoms
- Signed informed consent.
- Negative pregnancy test in fertile women.
Who cannot join
- Non-acceptance of participation in the study.
- Pregnancy.
- Hypersensitivity and/or previous intolerance to penicillins, piperacillin/tazobactam or carbapenems.
- Bacteremia, hematogenous infection or other concomitant infection.
- Immunosuppression.
- In case of obstructive uropathy, lack of early surgical resolution.
Show all 16Show fewer
- Evidence of acute or chronic prostatitis.
- Renal abscess
- Polycystic disease in the kidneys.
- Palliative care or life expectancy <90 days.
- Heart failure (NYHA) functional class III or IV.
- Liver cirrhosis.
- Renal insufficiency in dialysis treatment.
- Empirical active treatment against bacteria isolated by urine cultures other than E. coli or K. pneumoniae BLEE.
- Participation in another clinical trial for infections.
- Hypersensitivity to amide-type local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic Urinary Tract Infections Due to Extended-spectrum Β-lactamase (ESBL)-producing Escherichia Coli or Klebsiella Pneumoniae - (CAPITIS Study)
This study evaluates the efficacy in achieving clinical cure in non-bacteremic urinary tract infections (UTI) caused by Escherichia coli or Klebsiella pneumoniae producers of extended-spectrum β-lactamases (ESBL) in adult patients. Half of participants will receive Piperacillin/Tazobactam as treatment, while the other half will receive Carbapenems.
The investigators will verify that Piperacillin/Tazobactam is not inferior in achieving clinical cure, and that is not associated with a higher risk of adverse events in the directed treatment of non-bacteremic UTI compared to Carbapenems.
The researchers hope to improve the use of antibiotics in the non-bacteremic UTI, reducing the "collateral damage" related to a deterioration in the prognosis of patients and the generation of resistant germs caused by the use of broad-spectrum antibiotics as carbapenems.
Read the detailed description
Urinary tract infection (UTI) is a common cause of hospitalization worldwide, the prevalence throughout the life of UTI has been reported in about 50,000 cases per 100,000 women and 13,000 per 100,000 men in the United States. Hospitalization for community-acquired UTI is about 33%. Furthermore, the UTI related to bladder catheterization during hospitalization is the most common type of infection acquired, representing 40% of all nosocomial infections. UTI hospitalization is associated with a high cost to the healthcare system.
The diagnosis of UTI is based on demonstrating the presence of bacteria urine in patients with suggestive clinical manifestations and verifying the host's inflammatory response to infection. The most common etiological agents include Escherichia coli, Klebsiella spp, and Proteus spp, with different prevalence and antibiotic susceptibility profiles among different populations.
Currently the appropriate treatment of UTI is a growing concern in the medical community because Gram-negative, specifically Enterobacteriaceae, bacteria have acquired genes encoding antibiotic resistance mechanisms. The β-lactamase spread spectrum (ESBL) are documented with increasing frequency among microorganisms causing UTI. Current treatment options for ESBL bacteria include nitrofurantoin, fosfomycin, piperacillin-tazobactam, carbapenems, and aminoglycosides.
Carbapenems and piperacillin-tazobactam are antibiotics used in medical practice for many years, both therapies are licensed for the treatment of non-bacteremic UTI; however, so far there is not enough evidence to discriminate the best choice for the treatment of non-bacteremic UTI (although carbapenems are considered drugs of choice for infections caused by these microorganisms), but carbapenems use has been associated with an increased risk of "collateral damage" related to the generation of resistant germs.
The investigators will compare between piperacillin/tazobactam and carbapenems the effectiveness in achieving clinical cure for non-bacteremic UTI caused by ESBL microorganisms. Researchers principal hypothesis is that Piperacillin/tazobactam is not inferior to carbapenems in achieving clinical cure in the targeted treatment of UTI caused by non-bacteremic due to E. coli or K. pneumoniae ESBL in adults requiring hospitalization. Researchers will verify too if Piperacillin/Tazobactam is not associated with increased risk of adverse events during the targeted treatment of non-bacteremic ITU caused by E. coli or K. pneumoniae ESBL in adults requiring hospital admission, compared with Carbapenems therapy.
To perform the protocol researchers follows the recommendations for the design of trials investigating treatment options for resistant bacteria multidrug (Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment) of the United States Agency for Food and Drug Administration (FDA).
Participants will be included in the study with informed consent. The study variables will be obtained by patient interview and review of medical history. Variables will be recorded in a computerized database developed specifically for this study, with exclusive access for the researchers.
The estimated project duration is 2 years expected to begin in april of 2019.
- Conditions
- Urinary Tract Infections, Enterobacteriaceae Infections, Infection Due to ESBL Bacteria, Carbapenem, Escherichia Coli Infection, Klebsiella Pneumoniae Infection
- Being tested
- Meropenem, Ertapenem 1000 MG, Piperacillin, Tazobactam 4-0.5G Solution for Injection
- Keywords
- adult, Equivalence Trial, Randomized Controlled Trial, Comparative Study, Anti-Bacterial Agents/therapeutic use*, Meropenem, Ertapenem, Piperacillin, Tazobactam Drug Combination, Escherichia coli Infections/drug therapy, Klebsiella Infections/drug therapy
- Medical subject headings
- Urinary Tract Infections, Enterobacteriaceae Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
Carbapenems group intervention.
Ertapenem 1000 MGDrug
Carbapenems group intervention.
Piperacillin, Tazobactam 4-0.5G Solution for InjectionDrug
Piperacillin/Tazobactam group intervention.
| Study group | Role | What they receive |
|---|---|---|
| Carbapenems group | Active comparator | Meropenem (1g intravenously every 8 hours or adjusted to renal function) or Ertapenem (1g intravenously every 24 hours or adjusted to renal function) by 10 days. Receives: Drug: Meropenem; Drug: Ertapenem 1000 MG |
| Piperacillin/tazobactam. | Active comparator | Piperacillin / Tazobactam (4.5gr intravenously every 6 hours or adjusted to renal function) by 10 days. Receives: Drug: Piperacillin, Tazobactam 4-0.5G Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure.
Complete resolution of non-bacteremic urinary tract infection signs or symptoms (dysuria, urinary frequency, urinary urgency, suprapubic pain or temperature greater than 38 degrees Celsius) present at trial entry (and no new signs or symptoms) until the duration of investigational antibacterial drug therapy.
Investigators will compare the rate of clinical cure between the two treatment lines.
Measured: At 5-7 day after the end of treatment (cure test), or for early response after 5 days from the start of treatment.
Secondary outcomes (9)
Microbiologic cure.
Clinical cure (primary outcome) and demonstration that the bacterial pathogen found at trial entry is reduced to fewer than 100.000 CFU/mL on control urine culture.
Investigators will compare the rate of microbiologic cure between the two treatment lines.
Measured: At the 5-7 day after the end of treatment (cure test).
Mortality in patient follow-up.
All-cause Mortality Rate in the CAPITIS Study Population (Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic Urinary Tract Infections Due to Extended-spectrum β-lactamase (ESBL)-Producing Escherichia Coli or Klebsiella Pneumoniae.
Measured: Until day 30 after the first day of administration of the study drugs.
Length of hospital stay in patient follow-up.
Time since the assignment of the randomization until the patient leaves the hospital.
Measured: Until day 30 after the first day of administration of the study drugs.
Relapse.
Proportion of Subjects in the CAPITIS Study Population with a Relapse (All Indications).
Development of non-bacteremic urinary tract infection signs or symptoms (dysuria, urinary frequency, urinary urgency, suprapubic pain or temperature greater than 38 degrees Celsius) in patients with previous clinical and microbiological cure, plus positive urine culture with the same microorganism isolated in initial culture.
Investigators will compare the risk of relapse with each regimen.
Measured: Daily until day 30 after the first day of administration of the study drugs.
Reinfection.
Proportion of Subjects in the CAPITIS Study Population With a Reinfection (All Indications).
Development of non-bacteremic urinary tract infection signs or symptoms (dysuria, urinary frequency, urinary urgency, suprapubic pain or temperature greater than 38 degrees Celsius) in patients with previous clinical and microbiological cure, plus positive urine culture with different strains isolated in initial culture.
Investigators will compare the risk of reinfection with each regimen.
Measured: Daily until day 30 after the first day of administration of the study drugs.
Resistant clinical isolates in patient follow-up.
Proportion of Subjects in the CAPITIS Study Population With Resistant clinical isolates.
Appearance of clinical isolates of Escherichia coli or Klebsiella pneumoniae resistant piperacillin/tazobactam or carbapenems demonstrated in urine cultures will be evaluated.
Measured: Daily until day 30 after the first day of administration of the study drugs.
Adverse events in patient follow-up.
Proportion of Subjects in the CAPITIS Study Population With Adverse events (All Indications).
Any related adverse event occurring from the signing the informed consent form to end of follow.
Investigators have created a data collection notebook, a daily follow-up will be made in the participants and adverse events in patient will be recorded.
Measured: Daily until day 30 after the first day of administration of the study drugs.
ICU admission in patient follow-up.
Proportion of Subjects in the CAPITIS Study Population With ICU admission (All Indications).
Any admission to intensive care unit occurs from signing the informed consent form to end of patient follow.
Investigators have created a data collection notebook, a daily follow-up will be made in the participants and all admission in ICU will be recorded.
Measured: Daily until day 30 after the first day of administration of the study drugs.
Clinical or microbiological failure of antibiotic therapy in patient follow-up.
Proportion of Subjects in the CAPITIS Study Population With Clinical or microbiological failure of antibiotic therapy (All Indications).
Failure to achieve clinical or microbiologic cure until day 30, or die at any time since signing the informed consent form to end of follow-up.
Authors defined the clinical therapeutic failure as the persistence of at least one urinary symptom in the patient at the time of follow-up despite antibiotic therapy. Microbiological failure has been defined as the persistence of bacteria isolation major to 10.000 UFC/ml in second urine culture carried out in the study participant despite antibiotic therapy.
Investigators have created a questionnaire which will be checked daily with a urinary symptoms list. All findings will be recorded in a data collection notebook.
Measured: Daily until day 30 after the first day of administration of the study drugs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Dec 2024
- Study completion1 Apr 2026 (estimated)
Why it stopped: Low admission of patients with the condition to the hospital because it is a reference center for care of the SARS-CoV-2 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad del Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego F Viasus Perez, MD. PhD., Principal investigator, Universidad del Norte´s Hospital-Infectious Diseases.Andres F Estupinan Bohorquez, MD, Principal investigator, Universidad del Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891433
- Sponsor's protocol ID
- HUN-INF-CAPITIS-2018-1
- Acronym
- CAPITIS
- Status last verified
- Dec 2024
- First submitted
- 11 Mar 2019
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Rosso-Fernandez C, Sojo-Dorado J, Barriga A, Lavin-Alconero L, Palacios Z, Lopez-Hernandez I, Merino V, Camean M, Pascual A, Rodriguez-Bano J; FOREST Study Group. Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum beta-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial. BMJ Open. 2015 Mar 31;5(3):e007363. doi: 10.1136/bmjopen-2014-007363.
PubMed 25829373Pitout JD, Laupland KB. Extended-spectrum beta-lactamase-producing Enterobacteriaceae: an emerging public-health concern. Lancet Infect Dis. 2008 Mar;8(3):159-66. doi: 10.1016/S1473-3099(08)70041-0.
PubMed 18291338Paterson DL, Bonomo RA. Extended-spectrum beta-lactamases: a clinical update. Clin Microbiol Rev. 2005 Oct;18(4):657-86. doi: 10.1128/CMR.18.4.657-686.2005.
PubMed 16223952Tamma PD, Rodriguez-Bano J. The Use of Noncarbapenem beta-Lactams for the Treatment of Extended-Spectrum beta-Lactamase Infections. Clin Infect Dis. 2017 Apr 1;64(7):972-980. doi: 10.1093/cid/cix034.
PubMed 28362938Rodriguez-Bano J, Navarro MD, Retamar P, Picon E, Pascual A; Extended-Spectrum Beta-Lactamases-Red Espanola de Investigacion en Patologia Infecciosa/Grupo de Estudio de Infeccion Hospitalaria Group. beta-Lactam/beta-lactam inhibitor combinations for the treatment of bacteremia due to extended-spectrum beta-lactamase-producing Escherichia coli: a post hoc analysis of prospective cohorts. Clin Infect Dis. 2012 Jan 15;54(2):167-74. doi: 10.1093/cid/cir790. Epub 2011 Nov 4.
PubMed 22057701Harris PNA, Tambyah PA, Lye DC, Mo Y, Lee TH, Yilmaz M, Alenazi TH, Arabi Y, Falcone M, Bassetti M, Righi E, Rogers BA, Kanj S, Bhally H, Iredell J, Mendelson M, Boyles TH, Looke D, Miyakis S, Walls G, Al Khamis M, Zikri A, Crowe A, Ingram P, Daneman N, Griffin P, Athan E, Lorenc P, Baker P, Roberts L, Beatson SA, Peleg AY, Harris-Brown T, Paterson DL; MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN). Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):984-994. doi: 10.1001/jama.2018.12163.
PubMed 30208454
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic Urinary Tract Infections Due to Extended-spectrum Β-lactamase (ESBL)-producing Escherichia Coli or Klebsiella Pneumoniae - (CAPITIS Study)
- ClinicalTrials.gov ID
- NCT03891433
- Acronym / sponsor ID
- CAPITIS / HUN-INF-CAPITIS-2018-1
- Conditions
- Urinary Tract Infections, Enterobacteriaceae Infections, Infection Due to ESBL Bacteria, Carbapenem, Escherichia Coli Infection, Klebsiella Pneumoniae Infection
- Keywords
- adult, Equivalence Trial, Randomized Controlled Trial, Comparative Study, Anti-Bacterial Agents/therapeutic use*, Meropenem, Ertapenem, Piperacillin, Tazobactam Drug Combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Low admission of patients with the condition to the hospital because it is a reference center for care of the SARS-CoV-2 pandemic
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Universidad del NorteUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy in achieving clinical cure in non-bacteremic urinary tract infections (UTI) caused by Escherichia coli or Klebsiella pneumoniae producers of extended-spectrum β-lactamases (ESBL) in adult patients. Half of participants will receive Piperacillin/Tazobactam as treatment, while the other half will receive Carbapenems.
The investigators will verify that Piperacillin/Tazobactam is not inferior in achieving clinical cure, and that is not associated with a higher risk of adverse events in the directed treatment of non-bacteremic UTI compared to Carbapenems.
The researchers hope to improve the use of antibiotics in the non-bacteremic UTI, reducing the "collateral damage" related to a deterioration in the prognosis of patients and the generation of resistant germs caused by the use of broad-spectrum antibiotics as carbapenems.
Detailed description
Urinary tract infection (UTI) is a common cause of hospitalization worldwide, the prevalence throughout the life of UTI has been reported in about 50,000 cases per 100,000 women and 13,000 per 100,000 men in the United States. Hospitalization for community-acquired UTI is about 33%. Furthermore, the UTI related to bladder catheterization during hospitalization is the most common type of infection acquired, representing 40% of all nosocomial infections. UTI hospitalization is associated with a high cost to the healthcare system.
The diagnosis of UTI is based on demonstrating the presence of bacteria urine in patients with suggestive clinical manifestations and verifying the host's inflammatory response to infection. The most common etiological agents include Escherichia coli, Klebsiella spp, and Proteus spp, with different prevalence and antibiotic susceptibility profiles among different populations.
Currently the appropriate treatment of UTI is a growing concern in the medical community because Gram-negative, specifically Enterobacteriaceae, bacteria have acquired genes encoding antibiotic resistance mechanisms. The β-lactamase spread spectrum (ESBL) are documented with increasing frequency among microorganisms causing UTI. Current treatment options for ESBL bacteria include nitrofurantoin, fosfomycin, piperacillin-tazobactam, carbapenems, and aminoglycosides.
Carbapenems and piperacillin-tazobactam are antibiotics used in medical practice for many years, both therapies are licensed for the treatment of non-bacteremic UTI; however, so far there is not enough evidence to discriminate the best choice for the treatment of non-bacteremic UTI (although carbapenems are considered drugs of choice for infections caused by these microorganisms), but carbapenems use has been associated with an increased risk of "collateral damage" related to the generation of resistant germs.
The investigators will compare between piperacillin/tazobactam and carbapenems the effectiveness in achieving clinical cure for non-bacteremic UTI caused by ESBL microorganisms. Researchers principal hypothesis is that Piperacillin/tazobactam is not inferior to carbapenems in achieving clinical cure in the targeted treatment of UTI caused by non-bacteremic due to E. coli or K. pneumoniae ESBL in adults requiring hospitalization. Researchers will verify too if Piperacillin/Tazobactam is not associated with increased risk of adverse events during the targeted treatment of non-bacteremic ITU caused by E. coli or K. pneumoniae ESBL in adults requiring hospital admission, compared with Carbapenems therapy.
To perform the protocol researchers follows the recommendations for the design of trials investigating treatment options for resistant bacteria multidrug (Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment) of the United States Agency for Food and Drug Administration (FDA).
Participants will be included in the study with informed consent. The study variables will be obtained by patient interview and review of medical history. Variables will be recorded in a computerized database developed specifically for this study, with exclusive access for the researchers.
The estimated project duration is 2 years expected to begin in april of 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbapenems group | Active comparator | Drug: Meropenem, Drug: Ertapenem 1000 MGMeropenem (1g intravenously every 8 hours or adjusted to renal function) or Ertapenem (1g intravenously every 24 hours or adjusted to renal function) by 10 days. |
| Piperacillin/tazobactam. | Active comparator | Drug: Piperacillin, Tazobactam 4-0.5G Solution for InjectionPiperacillin / Tazobactam (4.5gr intravenously every 6 hours or adjusted to renal function) by 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years) with hospital admission for non-bacteremic UTI caused by E. coli or K. pneumoniae ESBL susceptible to piperacillin/tazobactam and carbapenems.
- Presence of any risk factor associated with UTI due to ESBL germs: older age 64 years, diabetes mellitus, bladder catheter, previous antibiotics in the last 6 months, hospitalization in the last 6 months, urological surgery in the last 30 days, infections recurrent urinary.
- Diagnosis of UTI confirmed by: 1) fever, 2) urine culture> 100000 CFU with isolation E. coli or K. pneumoniae ESBL susceptible to piperacillin / tazobactam and carbapenems, and 3) lumbar and / or abdominal pain with or without low urinary symptoms (dysuria, tenesmus, urgency), and 4) no other cause that explains the patient's symptoms
- Signed informed consent.
- Negative pregnancy test in fertile women.
Key exclusion criteria (16 listed)
- Non-acceptance of participation in the study.
- Pregnancy.
- Hypersensitivity and/or previous intolerance to penicillins, piperacillin/tazobactam or carbapenems.
- Bacteremia, hematogenous infection or other concomitant infection.
- Immunosuppression.
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 |
|---|---|---|
| MeropenemCarbapenems group intervention. | Drug | Carbapenems group |
| Ertapenem 1000 MGCarbapenems group intervention. | Drug | Carbapenems group |
| Piperacillin, Tazobactam 4-0.5G Solution for InjectionPiperacillin/Tazobactam group intervention. | Drug | Piperacillin/tazobactam. |
Primary outcome
Clinical cure.
Time frame: At 5-7 day after the end of treatment (cure test), or for early response after 5 days from the start of treatment.
Complete resolution of non-bacteremic urinary tract infection signs or symptoms (dysuria, urinary frequency, urinary urgency, suprapubic pain or temperature greater than 38 degrees Celsius) present at trial entry (and no new signs or symptoms) until the duration of investigational antibacterial drug therapy. Investigators will compare the rate of clinical cure between the two treatment lines.
9 secondary outcomes
Microbiologic cure.
Time frame: At the 5-7 day after the end of treatment (cure test).
Mortality in patient follow-up.
Time frame: Until day 30 after the first day of administration of the study drugs.
Length of hospital stay in patient follow-up.
Time frame: Until day 30 after the first day of administration of the study drugs.
Relapse.
Time frame: Daily until day 30 after the first day of administration of the study drugs.
Reinfection.
Time frame: Daily until day 30 after the first day of administration of the study drugs.
Resistant clinical isolates in patient follow-up.
Time frame: Daily until day 30 after the first day of administration of the study drugs.
Adverse events in patient follow-up.
Time frame: Daily until day 30 after the first day of administration of the study drugs.
ICU admission in patient follow-up.
Time frame: Daily until day 30 after the first day of administration of the study drugs.
Clinical or microbiological failure of antibiotic therapy in patient follow-up.
Time frame: Daily until day 30 after the first day of administration of the study drugs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 25829373Rosso-Fernandez C, Sojo-Dorado J, Barriga A, Lavin-Alconero L, Palacios Z, Lopez-Hernandez I, Merino V, Camean M, Pascual A, Rodriguez-Bano J; FOREST Study Group. Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum beta-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial. BMJ Open. 2015 Mar 31;5(3):e007363. doi: 10.1136/bmjopen-2014-007363.
- Background: PubMed 18291338Pitout JD, Laupland KB. Extended-spectrum beta-lactamase-producing Enterobacteriaceae: an emerging public-health concern. Lancet Infect Dis. 2008 Mar;8(3):159-66. doi: 10.1016/S1473-3099(08)70041-0.
- Background: PubMed 16223952Paterson DL, Bonomo RA. Extended-spectrum beta-lactamases: a clinical update. Clin Microbiol Rev. 2005 Oct;18(4):657-86. doi: 10.1128/CMR.18.4.657-686.2005.
- Background: PubMed 28362938Tamma PD, Rodriguez-Bano J. The Use of Noncarbapenem beta-Lactams for the Treatment of Extended-Spectrum beta-Lactamase Infections. Clin Infect Dis. 2017 Apr 1;64(7):972-980. doi: 10.1093/cid/cix034.
- Background: PubMed 22057701Rodriguez-Bano J, Navarro MD, Retamar P, Picon E, Pascual A; Extended-Spectrum Beta-Lactamases-Red Espanola de Investigacion en Patologia Infecciosa/Grupo de Estudio de Infeccion Hospitalaria Group. beta-Lactam/beta-lactam inhibitor combinations for the treatment of bacteremia due to extended-spectrum beta-lactamase-producing Escherichia coli: a post hoc analysis of prospective cohorts. Clin Infect Dis. 2012 Jan 15;54(2):167-74. doi: 10.1093/cid/cir790. Epub 2011 Nov 4.
- Background: PubMed 30208454Harris PNA, Tambyah PA, Lye DC, Mo Y, Lee TH, Yilmaz M, Alenazi TH, Arabi Y, Falcone M, Bassetti M, Righi E, Rogers BA, Kanj S, Bhally H, Iredell J, Mendelson M, Boyles TH, Looke D, Miyakis S, Walls G, Al Khamis M, Zikri A, Crowe A, Ingram P, Daneman N, Griffin P, Athan E, Lorenc P, Baker P, Roberts L, Beatson SA, Peleg AY, Harris-Brown T, Paterson DL; MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN). Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):984-994. doi: 10.1001/jama.2018.12163.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
Diego F Viasus Perez, MD. PhD. principal investigator
Universidad del Norte´s Hospital-Infectious Diseases.
Andres F Estupinan Bohorquez, MD principal investigator
Universidad del Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meropenem, Ertapenem 1000 MG and Piperacillin, Tazobactam 4-0.5G Solution for Injection in people with Urinary Tract Infections and Enterobacteriaceae Infections, run by Universidad del Norte at 1 site in Colombia.
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 5 inclusion and 16 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: paused, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 cure. (time frame: At 5-7 day after the end of treatment (cure test), or for early response after 5 days from the start of treatment.). 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 NCT03891433, which also lists 6 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 6 Dec 2024.