Intra-Abdominal Infection Clinical Trial
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)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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