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T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam (TEA)
This study is currently recruiting participants.
Study NCT00630513   Information provided by University of Bologna
First Received: February 27, 2008   Last Updated: September 8, 2008   History of Changes

February 27, 2008
September 8, 2008
January 2008
March 2010   (final data collection date for primary outcome measure)
Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00630513 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam
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)

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Intra-Abdominal Infection
  • Drug: Ertapenem
  • Drug: Ampicillin-Sulbactam
  • Experimental: 3 days regimen with Ertapenem
  • Active Comparator: 3 days treatment with Ampicillin-Sulbactam
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
142
September 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Fausto Catena, MD PhD +390516363235 fausto.catena@aosp.bo.it
Italy
 
NCT00630513
Dr. Fausto Catena MD PhD, University of Bologna - St Orsola-Malpighi University Hospital
T.E.A. Study
University of Bologna
St. Orsola Hospital
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
University of Bologna
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP