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

Primary Purpose

Intra-Abdominal Infection

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Ertapenem

Ampicillin-Sulbactam

About this trial

This is an interventional treatment trial for Intra-Abdominal Infection focused on measuring localized community acquired intra-abdominal infection (IAI), antibiotics, localized peritonitis, ertapenem

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

S.Orsola-Malpighi University Hospital - University of Bologna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

3 days regimen with Ertapenem

3 days treatment with Ampicillin-Sulbactam

Outcomes

Primary Outcome Measures

Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI

Secondary Outcome Measures

Any other complication

The total costs of antibiotic therapy

Full Information

NCT ID

NCT00630513

First Posted

February 27, 2008

Last Updated

August 17, 2011

Sponsor

University of Bologna

Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Study Identification

Unique Protocol Identification Number

NCT00630513

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Bologna

Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee

5. Study Description

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 patients with an community acquired IAI of mild to moderate severity.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intra-Abdominal Infection

Keywords

localized community acquired intra-abdominal infection (IAI), antibiotics, localized peritonitis, ertapenem

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

3 days regimen with Ertapenem

Arm Title

Arm Type

Active Comparator

Arm Description

3 days treatment with Ampicillin-Sulbactam

Intervention Type

Drug

Intervention Name(s)

Ertapenem

Intervention Description

3 days regimen with Ertapenem (1 g/day i.v.)

Intervention Type

Drug

Intervention Name(s)

Ampicillin-Sulbactam

Intervention Description

3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)

Primary Outcome Measure Information:

Title

Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Any other complication

Time Frame

intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up

Title

The total costs of antibiotic therapy

Time Frame

during hospital stay

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fausto Catena, MD PhD

Organizational Affiliation