Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections

Phase 3

Completed

• Conditions: Urinary Tract Infections
• Interventions: Drug: cefepime/AAI101 combination; Drug: Piperacillin/tazobactam

• Registration Number: NCT03687255
• Lead Sponsor: Allecra

Brief Summary

Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-24
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-27
• Primary Completion: 2020-01-30
• Study Completion: 2020-02-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1043

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cefepime/AAI101 combination	cefepime/AAI101 combination	Cefepime 2 g in combination with AAI101 500 mg q8h (2 hour infusion)
piperacillin/tazobactam	Piperacillin/tazobactam	Piperacillin 4 g in combination with Tazobactan 500 mg q8h (2 hour infusion)

Primary Outcome Measures

Name	Time	Method
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC)	7 days after EOT [±2 days] for patients receiving 7 days of treatment and 19 days after randomization [±2 days] for patients receiving more than 7 days of treatment.	Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication (\<103 CFU/mL in urine culture).

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in the m-MITT Population with overall treatment success at End of Treatment (EOT)	7 days for patients with cUTI only and up to 14 days for patients cUTI and blood stream infections	Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication (\<103 CFU/mL in urine culture).

Trial Locations

Locations (24)

St. Josephs Clinical Research; 🇺🇸 Anaheim, California, United States

Southbay Pharma Research; 🇺🇸 Buena Park, California, United States

Florida Urology Partners; 🇺🇸 Tampa, Florida, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Mercury Street Medical; 🇺🇸 Butte, Montana, United States

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States

HIGA Dr Ramon Carrillo; 🇦🇷 Buenos Aires, Argentina

Brest Regional Hospital; 🇧🇾 Brest, Belarus

MHAT Rahila Angelova AD, Pernik; 🇧🇬 Pernik, Bulgaria

University Hospital for Infectious Diseases "Dr. Fran Mihaljevic" Department for general infectious diseases; 🇭🇷 Zagreb, Croatia

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