Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
RECAPTURE: Ceftazidime-Avibactam vs Doripenem in cUTI
NCT01599806Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2012
- Primary completion
- Aug 2014
- Countries
- 17
- Sponsor
- Pfizer
- Modality
- Irreversible Covalent Inhibitors
- Conditions
- complicated urinary tract infection (cUTI)acute pyelonephritis
01
Overview
Phase 3, randomised, double-blind trial of ceftazidime + avibactam in complicated urinary tract infection (cUTI) and acute pyelonephritis (2 arms), sponsored by Pfizer. Primary endpoints: Patient-reported Symptomatic Response at Day 5, Combined Patient-reported Symptomatic and Microbiological Response at TOC and 1 more. Started Oct 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ceftazidime-Avibactam
IV Ceftazidime-Avibactam followed by optional oral therapy
Doripenem
IV Doripenem followed by optional oral therapy
03
Who it enrols
Hospitalized adults 18-90 years old with pyuria and positive urine culture for a Gram-negative pathogen susceptible to study drugs. Excludes patients with Gram-positive or resistant pathogens, fungal UTI, dialysis, renal transplant, immunocompromised status, or septic shock.
04
Endpoints
Primary
Patient-reported Symptomatic Response at Day 5
Combined Patient-reported Symptomatic and Microbiological Response at TOC
Per-patient Microbiological Response at TOC
Secondary
Per-patient Microbiological Response at EOT (IV)
Per-patient Microbiological Response at LFU
Investigator Determined Clinical Response at EOT (IV)
Investigator Determined Clinical Response at TOC
Investigator Determined Clinical Response at LFU
Time to First Defervescence While on IV Study Therapy
Per-pathogen Microbiological Response
Plasma Concentrations for Ceftazidime
05
Results
Primary endpoints met
Beyond the preview
Go deeper on NCT01599806.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01599806.