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A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections

NCT00965848 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2013-10-30

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).

Conditions

Interventions

DRUG

Doripenem

Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.

Sponsors & Collaborators

  • Janssen-Cilag Ltd.,Thailand

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Ltd.,Thailand Clinical Trial · Janssen-Cilag Ltd.,Thailand

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Thailand

Study Locations

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Entities

Diseases

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 NCT00965848 on ClinicalTrials.gov