NCT00630513

T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam

A Prospective, Double-blind, Multi Center, Randomized Clinical Study to Compare the Efficacy and Safety of Ertapenem 3 Days Versus Ampicillin-Sulbactam 3 Days in the Treatment of Localized Community Acquired Intra-abdominal Infection (IAI). (T.E.A. Study Three Days Ertapenem vs Three Days Ampicillin- Sulbactam)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study was to compare the activity (efficacy and safety) of Ertapenem administered according to a short treatment for three days versus a short treatment for three days with AS in patients with an community acquired IAI of mild to moderate severity.

Detailed description

The study project is a prospective, randomized controlled investigation. The study will be performed in the Department of Transplant, General and Emergency Surgery of St Orsola-Malpighi University Hospital (Bologna, Italy), a large teaching institution, with the participation of all surgeons who accept to be involved in. The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations. The tolerability and efficacy of a 3 days treatment with Ampicillin- Sulbactam (AS 3g x 3/ day i.v.) is compared a 3 days regimen with Ertapenem (1 g/day i.v.). in patients with localized peritonitis with a blinded evaluation of efficacy end points. Evaluation of cure or failure is blinded by use of designated third party individuals who are unaware of the treatment assigned to the patients.

Conditions

• Intra-Abdominal Infection

Interventions

Type	Name	Description
DRUG	Ertapenem	3 days regimen with Ertapenem (1 g/day i.v.)
DRUG	Ampicillin-Sulbactam	3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-06-01
• Completion: 2010-12-01
• First posted: 2008-03-07
• Last updated: 2011-08-18

Locations

1 site across 1 country: Italy