Randomized, Double-Blind, Multi-Center Study of Cefepime/AAI101 in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
Overview
- Phase
- Phase 2
- Intervention
- Cefepime 1G - 2G / AAI101 0.5G - 0.75G
- Conditions
- Urinary Tract Infections
- Sponsor
- Allecra
- Enrollment
- 45
- Locations
- 5
- Primary Endpoint
- Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cefepime 1G - 2G / AAI101 0.5G - 0.75G
cefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg
Intervention: Cefepime 1G - 2G / AAI101 0.5G - 0.75G
cefepime monotherapy
cefepime 1 g or cefepime 2 g
Intervention: cefepime 1 g or cefepime 2 g
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.(6 to 9 days post-End of Treatment)