Urinary Tract InfectionsPhase 2NCT03680612
Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
A Phase 2 study testing Cefepime 1G - 2G / AAI101 0.5G - 0.75G and cefepime 1 g or cefepime 2 g in people with Urinary Tract Infections, run by Allecra at 5 sites in 5 countries.
Trial summary
Phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis. All study cohorts were randomised in a 2:1 ratio. Treatment duration for each cohort was 7 to 10 days. Patients were not permitted to switch to oral therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Cefepime 1G - 2G / AAI101 0.5G - 0.75G and cefepime 1 g or cefepime 2 g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 5 Sep 2017to 14 Feb 2018
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with clinical signs and/or symptoms of cUTI or acute pyelonephritis that were expected to require hospitalization and initial treatment with at least 7 days of i.v.
- antibiotics.
Who cannot join
- Patients with concurrent infection that would interfere with evaluation of response to the study antibiotics;
- Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
- Patients receiving effective antibacterial drug therapy for any indication for a continuous duration of >24 hours during the previous 72 hours before the study-qualifying baseline urine was obtained or receiving any amount of potentially therapeutic antibacterial therapy after collection of the pre-treatment baseline urine culture and before administration of the first dose of study drug;
- Patients likely to require the use of an antibiotic for cUTI or acute pyelonephritis prophylaxis during participation in the study;
- Patients with confirmed fungal urinary tract infection at the screening visit (with ≥103 fungal colony forming units [CFU]/mL); or
- Patients with intractable urinary infection at baseline that the Investigator anticipated would require >10 days of study drug therapy were excluded from participation
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Poland1 site
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
Warsaw, 02-507
Slovakia1 site
Fakultna nemocnica s poliklinikou J.A. Reimana Presov
Prešov, 081 81
Ukraine1 site
Chernihiv City Hospital #2 of Chernihiv City Council, department of Urology
Chernihiv, 14034
About this study
Official title: Randomized, Double-Blind, Multi-Center Study of Cefepime/AAI101 in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
Phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis. All study cohorts were randomised in a 2:1 ratio. Treatment duration for each cohort was 7 to 10 days. Patients were not permitted to switch to oral therapy.
Cohort 1: 15 patients treated with cefepime 1 g/AAI101 500 mg intravenous (i.v.) infusion over 2 hours once every 8 hours (q8h), and 7 patients treated with cefepime 1 g i.v. infusion over 2 hours q8h.
Cohort 2: 15 patients treated with cefepime 2 g/AAI101 750 mg i.v. infusion over 2 hours q8h, and 8 patients treated with cefepime 2 g i.v. infusion over 2 hours q8h.
- Conditions
- Urinary Tract Infections
- Being tested
- Cefepime 1G - 2G / AAI101 0.5G - 0.75G, cefepime 1 g or cefepime 2 g
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefepime 1G - 2G / AAI101 0.5G - 0.75GDrug
Also called cefepime/AAI101 combination
Experimental drug
cefepime 1 g or cefepime 2 gDrug
Also called cefepime alone
cefepime monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cefepime 1G - 2G / AAI101 0.5G - 0.75G | Experimental | cefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg Receives: Drug: Cefepime 1G - 2G / AAI101 0.5G - 0.75G |
| cefepime monotherapy | Active comparator | cefepime 1 g or cefepime 2 g Receives: Drug: cefepime 1 g or cefepime 2 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
Microbiological response is eradication for each baseline pathogen
Measured: 6 to 9 days post-End of Treatment
Secondary outcomes (1)
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
Microbiological response is eradication for each baseline pathogen
Measured: 6 to 9 days post-End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start5 Sep 2017
- Primary completion14 Feb 2018
- Study completion14 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allecra
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680612
- Sponsor's protocol ID
- AT-201
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Multi-Center Study of Cefepime/AAI101 in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- ClinicalTrials.gov ID
- NCT03680612
- Acronym / sponsor ID
- AT-201
- Conditions
- Urinary Tract Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AllecraIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 21 Sep 2018 (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.
Phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis. All study cohorts were randomised in a 2:1 ratio. Treatment duration for each cohort was 7 to 10 days. Patients were not permitted to switch to oral therapy.
Cohort 1: 15 patients treated with cefepime 1 g/AAI101 500 mg intravenous (i.v.) infusion over 2 hours once every 8 hours (q8h), and 7 patients treated with cefepime 1 g i.v. infusion over 2 hours q8h.
Cohort 2: 15 patients treated with cefepime 2 g/AAI101 750 mg i.v. infusion over 2 hours q8h, and 8 patients treated with cefepime 2 g i.v. infusion over 2 hours q8h.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefepime 1G - 2G / AAI101 0.5G - 0.75G | Experimental | Drug: Cefepime 1G - 2G / AAI101 0.5G - 0.75Gcefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg |
| cefepime monotherapy | Active comparator | Drug: cefepime 1 g or cefepime 2 gcefepime 1 g or cefepime 2 g |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients with clinical signs and/or symptoms of cUTI or acute pyelonephritis that were expected to require hospitalization and initial treatment with at least 7 days of i.v.
- antibiotics.
Key exclusion criteria (6 listed)
- Patients with concurrent infection that would interfere with evaluation of response to the study antibiotics;
- Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
- Patients receiving effective antibacterial drug therapy for any indication for a continuous duration of >24 hours during the previous 72 hours before the study-qualifying baseline urine was obtained or receiving any amount of potentially therapeutic antibacterial therapy after collection of the pre-treatment baseline urine culture and before administration of the first dose of study drug;
- Patients likely to require the use of an antibiotic for cUTI or acute pyelonephritis prophylaxis during participation in the study;
- Patients with confirmed fungal urinary tract infection at the screening visit (with ≥103 fungal colony forming units [CFU]/mL); or
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 |
|---|---|---|
| Cefepime 1G - 2G / AAI101 0.5G - 0.75GAlso: cefepime/AAI101 combinationExperimental drug | Drug | Cefepime 1G - 2G / AAI101 0.5G - 0.75G |
| cefepime 1 g or cefepime 2 gAlso: cefepime alonecefepime monotherapy | Drug | cefepime monotherapy |
Primary outcome
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
Time frame: 6 to 9 days post-End of Treatment
Microbiological response is eradication for each baseline pathogen
1 secondary outcome
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
Time frame: 6 to 9 days post-End of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Urinary Tract Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
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
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
RecruitingPhase 2
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection
Chronic 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefepime 1G - 2G / AAI101 0.5G - 0.75G and cefepime 1 g or cefepime 2 g in people with Urinary Tract Infections, run by Allecra at 5 sites in 5 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 2 inclusion and 6 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 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia, Hungary, Poland, Slovakia, Ukraine. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population (time frame: 6 to 9 days post-End of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.