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

Information source: University of Bologna
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intra-Abdominal Infection

Intervention: Ertapenem (Drug); Ampicillin-Sulbactam (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Bologna

Official(s) and/or principal investigator(s):
Fausto Catena, MD PhD, Study Director, Affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
Luca Ansaloni, MD, Principal Investigator, Affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
Giorgio Ercolani, MD, Principal Investigator, Affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
Antonio Daniele Pinna, MD, Study Chair, Affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
Cristina Puggioli, MD, Principal Investigator, Affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
Salomone Di Saverio, M.D., Principal Investigator, Affiliation: S.Orsola-Malpighi University Hospital - University of Bologna

Overall contact:
Fausto Catena, MD PhD, Phone: +390516363235, Email: fausto.catena@aosp.bo.it

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.

Clinical Details

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

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

Secondary outcome:

Any other complication

The total costs of antibiotic therapy

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Fausto Catena, MD PhD, Phone: +390516363235, Email: fausto.catena@aosp.bo.it

S.Orsola-Malpighi University Hospital - University of Bologna, Bologna, Italy; Recruiting
Fausto Catena, M.D. PhD, Phone: +396363235, Email: fausto.catena@aosp.bo.it
Fausto Catena, M.D. PhD, Principal Investigator
Luca Ansaloni, M.D., Principal Investigator
Filippo Gazzotti, M.D., Sub-Investigator
Luigi D'Alessandro, M.D., Sub-Investigator
Giorgio Ercolani, MD, Principal Investigator
Antonio Daniele Pinna, MD, Principal Investigator
Cristina Puggioli, MD, Principal Investigator
Federico Coccolini, MD, Sub-Investigator
Salomone Di Saverio, M.D., Principal Investigator
Additional Information

Related publications:

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 >/=5 days in community-acquired intraabdominal infection. J Gastrointest Surg. 2008 Mar;12(3):592-600. Epub 2007 Sep 11.

Starting date: January 2008
Last updated: September 8, 2008

Page last updated: October 04, 2010

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