Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections
- Conditions
- Urinary Tract Infections
- Interventions
- Drug: cefepime/AAI101 combinationDrug: 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1043
Not provided
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)
Clinica Internacional - Sede San Borja
🇵🇪Lima, Peru
Bugat Pal Korhaz
🇭🇺Gyöngyös, Hungary
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
🇵🇱Warsaw, Poland
Unimed Adjara - Kutaisi oncological centre
🇬🇪Kutaisi, Georgia
Interne oddelenie, Nemocnica Malacky, Nemocnicna a.s.
🇸🇰Malacky, Slovakia
Florida Urology Partners
🇺🇸Tampa, Florida, United States
Brest Regional Hospital
🇧🇾Brest, Belarus
University Hospital for Infectious Diseases "Dr. Fran Mihaljevic" Department for general infectious diseases
🇭🇷Zagreb, Croatia
Republican Siauliai caunty hospital
🇱🇹Šiauliai, Lithuania
Scientific Research Center Eco-Safety
🇷🇺Saint Petersburg, Russian Federation
MHAT Rahila Angelova AD, Pernik
🇧🇬Pernik, Bulgaria
Clinical Hospital Center Zvezdara
🇷🇸Belgrade, Serbia
Clinical Projects Research
🇿🇦Worcester, South Africa
Southbay Pharma Research
🇺🇸Buena Park, California, United States
St. Josephs Clinical Research
🇺🇸Anaheim, California, 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
Uroklinika, LLC
🇱🇻Riga, Latvia
Centro Especializado en Investigación Clínica S.C.
🇲🇽Boca Del Río, Mexico
Chernihiv City Hospital #2 of Chernihiv City Council, department of Urology
🇺🇦Chernihiv, Ukraine
Hospital del Mar, Department of Infectious Disease
🇪🇸Barcelona, Spain
Tartu University Hospital
🇪🇪Tartu, Estonia