Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
TEA Study: Ertapenem vs Ampicillin-Sulbactam in IAI
NCT00630513Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2008
- Primary completion
- Jun 2010
- Countries
- 1
- Sponsor
- Alma Mater Studiorum – Università di Bologna
- Modality
- Small Molecules
- Drugs
- ertapenem
- Conditions
- Intra-abdominal infection (IAI)
01
Overview
Phase 4, randomised, double-blind trial of ertapenem in Intra-abdominal infection (IAI) (2 arms), sponsored by Alma Mater Studiorum – Università di Bologna. Primary endpoint: Failure rate of short therapy at 3 days. Started Jan 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ertapenem
Ertapenem 1 g/day i.v. for 3 days
Ampicillin-Sulbactam
Ampicillin-Sulbactam 3g x 3/day i.v. for 3 days
03
Who it enrols
Adult patients with localized community-acquired intra-abdominal infection requiring surgery. Excludes patients with severe hepatic or renal disease, pregnancy, or lactation.
04
Endpoints
Primary
Failure rate of short therapy
Secondary
Any other complication
Total costs of antibiotic therapy
Beyond the preview
Go deeper on NCT00630513.
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 NCT00630513.