Urinary Tract Infections
Conditions
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.
Interventions
DRUGCefepime 1G - 2G / AAI101 0.5G - 0.75G
Experimental drug
DRUGcefepime 1 g or cefepime 2 g
cefepime monotherapy
Sponsors
Medpace, Inc.
Allecra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population | 6 to 9 days post-End of Treatment | Microbiological response is eradication for each baseline pathogen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population. | 6 to 9 days post-End of Treatment | Microbiological response is eradication for each baseline pathogen |
Countries
Czechia, Hungary, Poland, Slovakia, Ukraine
Outcome results
None listed