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

Overview

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 Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: June 2010

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: E
    • 3 days regimen with Ertapenem
  • Active Comparator: AS
    • 3 days treatment with Ampicillin-Sulbactam

Clinical Trial Outcome Measures

Primary Measures

  • Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI
    • Time Frame: 3 days

Secondary Measures

  • Any other complication
    • Time Frame: intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up
  • The total costs of antibiotic therapy
    • Time Frame: during hospital stay

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Bologna
  • Collaborator
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Provider of Information About this Clinical Study
    • Dr. Fausto Catena MD PhD, University of Bologna – St Orsola-Malpighi University Hospital
  • Overall Official(s)
    • Fausto Catena, MD PhD, Study Director, S.Orsola-Malpighi University Hospital – University of Bologna
    • Luca Ansaloni, MD, Principal Investigator, S.Orsola-Malpighi University Hospital – University of Bologna
    • Giorgio Ercolani, MD, Principal Investigator, S.Orsola-Malpighi University Hospital – University of Bologna
    • Antonio Daniele Pinna, MD, Study Chair, S.Orsola-Malpighi University Hospital – University of Bologna
    • Cristina Puggioli, MD, Principal Investigator, S.Orsola-Malpighi University Hospital – University of Bologna
    • Salomone Di Saverio, M.D., Principal Investigator, S.Orsola-Malpighi University Hospital – University of Bologna

References

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. doi: 10.1007/s11605-007-0277-x. Epub 2007 Sep 11.

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