REPRISE: Phase 3 study of CAZ-AVI vs Best Available Therapy
Research type
Research Study
Full title
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
IRAS ID
144988
Contact name
Jane Minton
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2012-000726-21
Clinicaltrials.gov Identifier
Research summary
Urinary tract infections (UTIs) are among the most commonly acquired infections. Complicated UTIs (cUTIs) are more severe and can include kidney infection; cUTI usually requires prolonged treatment. Complicated intra-abdominal infections (cIAIs) are serious infections in the abdomen which can be life-threatening and very hard to treat. Hospitalisation for surgery or drainage and antibiotic treatment is usually required.
Gram-negative pathogens (bacteria) are responsible for many of these infections. Multidrug-resistant Gram-negative pathogens are increasing and their treatment options are extremely limited.
This study, sponsored by AstraZeneca, is being done to evaluate the efficacy, safety, and tolerability of a new treatment for Gram-negative cUTIs and cIAIs, called ceftazidime avibactam (CAZ-AVI). It is a combination of an experimental drug (avibactam) and licensed antibiotic (ceftazidime). So far, CAZ-AVI has been studied in about 193 participants in other trials. This open-label study will compare CAZ-AVI with the Best Available Treatment (BAT).Approximately 400 hospitalized patients diagnosed with cIAI or cUTI caused by ceftazidime resistant Gram negative pathogens will be enrolled in the study from approximately 150 centres worldwide.
Once the study doctor has determined and documented the BAT that the patient would receive, the patient will be randomized in a 1:1 ratio to receive either CAZ-AVI or BAT.
Each patient will receive 5-21 days of study treatment and is expected to complete the study within 28 days. After at least 5 days of study therapy, treatment may be discontinued. Patients must then return to the hospital for 2-3 follow-up visits.
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There will be between 9 and 26 study visits; the duration of the study treatment will depend on how quickly the study drugs work and the study doctor’s clinical judgement. CAZ-AVI treatment will be administered intravenously every 8 hours, each IV treatment will last 2-3 hours. Study visits will include physical examinations, blood/urine tests and ECGs.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/0021
Date of REC Opinion
13 Mar 2014
REC opinion
Further Information Favourable Opinion