Overview

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

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Bologna
Collaborators:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
St. Orsola Hospital
Treatments:
Ampicillin
Ertapenem
Sulbactam
Sultamicillin
Criteria
Inclusion Criteria:

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 Criteria:

- 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.