Clinical trial NCT03680612: Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
Official title: Randomized, Double-Blind, Multi-Center Study of Cefepime/AAI101 in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Infections
Lead sponsor: Allecra
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2018-09-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
timeFrame: 6 to 9 days post-End of Treatment
Secondary outcomes:
measure: Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
timeFrame: 6 to 9 days post-End of Treatment
Other outcomes:
Locations:
city: Kromeriz
country: Czechia
facility: Kromerizska nemocnice
city: Budapest
country: Hungary
facility: Jahn Ferenc Del-pesti Korhaz
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
city: Prešov
country: Slovakia
facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov
city: Chernihiv
country: Ukraine
facility: Chernihiv City Hospital #2 of Chernihiv City Council, department of Urology
Study officials:
References: