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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)

NCT00389987

Complicated Intra-Abdominal Infections

COMPLETED PHASE3

Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections

NCT01265784

Complicated Intra-abdominal Infection

COMPLETED PHASE2

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

NCT03358576

Intra Abdominal Infections

COMPLETED PHASE3

Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

NCT03357614

Complicated Urinary Tract Infections

COMPLETED PHASE3

Ertapenem in Patients With Urosepsis

NCT03859362

Patients With Urosepis and Received Ertapenem for Treatment

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intra-Abdominal Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

E

3 days regimen with Ertapenem

Group Type EXPERIMENTAL

Ertapenem

Intervention Type DRUG

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

AS

3 days treatment with Ampicillin-Sulbactam

Group Type ACTIVE_COMPARATOR

Ampicillin-Sulbactam

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ertapenem

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

Intervention Type DRUG

Ampicillin-Sulbactam

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Bologna - St Orsola-Malpighi University Hospital