T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam (TEA)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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)|
- Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
- Any other complication [ Time Frame: intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up ] [ Designated as safety issue: Yes ]
- The total costs of antibiotic therapy [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
3 days regimen with Ertapenem
3 days regimen with Ertapenem (1 g/day i.v.)
Active Comparator: AS
3 days treatment with Ampicillin-Sulbactam
3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)
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.
|S.Orsola-Malpighi University Hospital - University of Bologna|
|Study Director:||Fausto Catena, MD PhD||S.Orsola-Malpighi University Hospital - University of Bologna|
|Principal Investigator:||Luca Ansaloni, MD||S.Orsola-Malpighi University Hospital - University of Bologna|
|Principal Investigator:||Giorgio Ercolani, MD||S.Orsola-Malpighi University Hospital - University of Bologna|
|Study Chair:||Antonio Daniele Pinna, MD||S.Orsola-Malpighi University Hospital - University of Bologna|
|Principal Investigator:||Cristina Puggioli, MD||S.Orsola-Malpighi University Hospital - University of Bologna|
|Principal Investigator:||Salomone Di Saverio, M.D.||S.Orsola-Malpighi University Hospital - University of Bologna|