Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-Blind, Multi-Center Study of Cefepime/AAI101 in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: Cefepime 1G - 2G / AAI101 0.5G - 0.75G
* Drug: cefepime 1 g or cefepime 2 g


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: • 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. Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefepime 1G - 2G / AAI101 0.5G - 0.75G<br>cefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg | Drug: Cefepime 1G - 2G / AAI101 0.5G - 0.75G<br>* Experimental drug<br>* Other names: cefepime/AAI101 combination;|
| Active Comparator: cefepime monotherapy<br>cefepime 1 g or cefepime 2 g | Drug: cefepime 1 g or cefepime 2 g<br>* cefepime monotherapy<br>* Other names: cefepime alone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 to 9 days post-End of Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population. | Microbiological response is eradication for each baseline pathogen | 6 to 9 days post-End of Treatment |