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) - TEA Study

• Conditions: localized community acquired intra-abdominal infection (IAI); MedDRA version: 6.1Level: HLTClassification code 10017967

• Registration Number: EUCTR2007-002121-80-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-15
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Adult patients (>18 years)

to require surgical intervention within 24 hours of diagnosis.

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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified