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

NCT00630513 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2011-08-18

No results posted yet for this study

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

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.)

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER

  • University of Bologna

    lead OTHER

Principal Investigators

  • Fausto Catena, MD PhD · S.Orsola-Malpighi University Hospital - University of Bologna

  • Luca Ansaloni, MD · S.Orsola-Malpighi University Hospital - University of Bologna

  • Giorgio Ercolani, MD · S.Orsola-Malpighi University Hospital - University of Bologna

  • Antonio Daniele Pinna, MD · S.Orsola-Malpighi University Hospital - University of Bologna

  • Cristina Puggioli, MD · S.Orsola-Malpighi University Hospital - University of Bologna

  • Salomone Di Saverio, M.D. · S.Orsola-Malpighi University Hospital - University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630513 on ClinicalTrials.gov