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

Intra-Abdominal Infection Clinical Trial

— TEA  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630513
• Other study ID #: T.E.A. Study
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2008
• Last updated: August 17, 2011
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2008
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Intra-Abdominal Infection
• Intraabdominal Infections

Intervention

Drug:
• Ertapenem
3 days regimen with Ertapenem (1 g/day i.v.)
• Ampicillin-Sulbactam
3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)

Locations

Country	Name	City	State
Italy	S.Orsola-Malpighi University Hospital - University of Bologna	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
University of Bologna	St. Orsola Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Basoli A, Chirletti P, Cirino E, D'Ovidio NG, Doglietto GB, Giglio D, Giulini SM, Malizia A, Taffurelli M, Petrovic J, Ecari M; Italian Study Group. A prospective, double-blind, multicenter, randomized trial comparing ertapenem 3 vs >or=5 days in community-acquired intraabdominal infection. J Gastrointest Surg. 2008 Mar;12(3):592-600. Epub 2007 Sep 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI		3 days	Yes
Secondary	Any other complication		intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up	Yes
Secondary	The total costs of antibiotic therapy		during hospital stay	No