Status:
COMPLETED
T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam
Lead Sponsor:
University of Bologna
Collaborating Sponsors:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Intra-Abdominal Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 patien...
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 Hos...
Eligibility Criteria
Inclusion
- Adult patients ( \> 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity):
- Acute appendicitis: Ruptured or perforated with abscess
- Acute diverticulitis with perforation and/or abscess
- Acute cholecystitis (including gangrenous) with either rupture or perforation
- Acute gastric and duodenal ( \> 24 hours) perforation
- Traumatic (\> 12 hours) perforation of the intestines
- Secondary peritonitis due to perforated viscus
- Intra-abdominal abscess (including of liver and spleen)
Exclusion
- Traumatic bowel perforation requiring surgery within 12 hours
- Perforation of gastroduodenal ulcers requiring surgery within 24 hours
- other intra-abdominal processes in which the primary etiology was unlikely to be infectious.
- Patients lactating or pregnant
- Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics
- Patients with rapidly progressive or terminal illness;
- Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance \< 0.5 ml/min/1.73 m2);
- Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00630513
Start Date
January 1 2008
End Date
December 1 2010
Last Update
August 18 2011
Active Locations (1)
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1
S.Orsola-Malpighi University Hospital - University of Bologna
Bologna, Italy