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

This study has been completed.
Sponsor:
Collaborator:
St. Orsola Hospital
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00630513
First received: February 27, 2008
Last updated: August 17, 2011
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Intra-Abdominal Infection
Drug: Ertapenem
Drug: Ampicillin-Sulbactam
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Any other complication [ Time Frame: intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up ] [ Designated as safety issue: Yes ]
  • The total costs of antibiotic therapy [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E
3 days regimen with Ertapenem
Drug: Ertapenem
3 days regimen with Ertapenem (1 g/day i.v.)
Active Comparator: AS
3 days treatment with Ampicillin-Sulbactam
Drug: Ampicillin-Sulbactam
3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630513

Locations
Italy
S.Orsola-Malpighi University Hospital - University of Bologna
Bologna, Italy
Sponsors and Collaborators
University of Bologna
St. Orsola Hospital
Investigators
Study Director: Fausto Catena, MD PhD S.Orsola-Malpighi University Hospital - University of Bologna
Principal Investigator: Luca Ansaloni, MD S.Orsola-Malpighi University Hospital - University of Bologna
Principal Investigator: Giorgio Ercolani, MD S.Orsola-Malpighi University Hospital - University of Bologna
Study Chair: Antonio Daniele Pinna, MD S.Orsola-Malpighi University Hospital - University of Bologna
Principal Investigator: Cristina Puggioli, MD S.Orsola-Malpighi University Hospital - University of Bologna
Principal Investigator: Salomone Di Saverio, M.D. S.Orsola-Malpighi University Hospital - University of Bologna
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Fausto Catena MD PhD, University of Bologna - St Orsola-Malpighi University Hospital
ClinicalTrials.gov Identifier: NCT00630513     History of Changes
Other Study ID Numbers: T.E.A. Study
Study First Received: February 27, 2008
Last Updated: August 17, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
localized community acquired intra-abdominal infection (IAI)
antibiotics
localized peritonitis
ertapenem

Additional relevant MeSH terms:
Intraabdominal Infections
Infection
Ampicillin
Sulbactam
Sultamicillin
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014