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

University of Bologna

Status and phase

Completed

Phase 4

Conditions

Intra-Abdominal Infection

Treatments

Drug: Ertapenem

Drug: Ampicillin-Sulbactam

Study type

Interventional

Funder types

Other

Identifiers

NCT00630513

T.E.A. Study

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

142 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.