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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
142
3 days regimen with Ertapenem (1 g/day i.v.)
3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)
S.Orsola-Malpighi University Hospital - University of Bologna
Bologna, Italy
Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI
Time frame: 3 days
Any other complication
Time frame: intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up
The total costs of antibiotic therapy
Time frame: during hospital stay
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