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

NCT00630513 | Completed Phase 4

• 1 other identifier: T.E.A. Study
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intra-Abdominal Infection

Keywords

localized community acquired intra-abdominal infection (IAI); antibiotics; localized peritonitis; ertapenem

Outcome Measures

Primary Outcomes (1)

• Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI

  3 days

Secondary Outcomes (2)

• Any other complication

  intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up

• The total costs of antibiotic therapy

  during hospital stay

Study Arms (2)

E

EXPERIMENTAL

3 days regimen with Ertapenem

Drug: Ertapenem

AS

ACTIVE COMPARATOR

3 days treatment with Ampicillin-Sulbactam

Drug: Ampicillin-Sulbactam

Interventions

Ertapenem DRUG

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

E

Ampicillin-Sulbactam DRUG

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

AS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator

Study Sites (1)

S.Orsola-Malpighi University Hospital - University of Bologna

Bologna, Italy

Location

Related Publications (3)

• 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.

  PMID: 17846853 BACKGROUND

• Catena F, Vallicelli C, Ansaloni L, Sartelli M, Di Saverio S, Schiavina R, Pasqualini E, Amaduzzi A, Coccolini F, Cucchi M, Lazzareschi D, Baiocchi GL, Pinna AD. T.E.A. Study: three-day ertapenem versus three-day Ampicillin-Sulbactam. BMC Gastroenterol. 2013 Apr 30;13:76. doi: 10.1186/1471-230X-13-76.

  PMID: 23631512 DERIVED

• Coccolini F, Catena F, Ansaloni L, Ercolani G, Di Saverio S, Gazzotti F, Lazzareschi D, Pinna AD. A prospective, multi centre, 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. (T.E.A. Study: Three days Ertapenem vs three days Ampicillin-sulbactam). BMC Gastroenterol. 2011 Apr 18;11:42. doi: 10.1186/1471-230X-11-42.

  PMID: 21501482 DERIVED

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Ertapenem; sultamicillin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fausto Catena, MD PhD

  S.Orsola-Malpighi University Hospital - University of Bologna

  STUDY DIRECTOR

• Luca Ansaloni, MD

  S.Orsola-Malpighi University Hospital - University of Bologna

  PRINCIPAL INVESTIGATOR

• Giorgio Ercolani, MD

  S.Orsola-Malpighi University Hospital - University of Bologna

  PRINCIPAL INVESTIGATOR

• Antonio Daniele Pinna, MD

  S.Orsola-Malpighi University Hospital - University of Bologna

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 7, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 18, 2011

Record last verified: 2008-09

Locations

IT (1)