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A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia

NCT00515034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2019-03-19

Study results available
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Summary

The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The study population will include hospitalized patients (or patients resident in a chronic health care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated Intra-abdominal Infection.

Conditions

Interventions

DRUG

Imipenem/cilastatin

Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion

DRUG

Imipenem/cilastatin

Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion

DRUG

Doripenem

1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days

DRUG

Doripenem

1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

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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 NCT00515034 on ClinicalTrials.gov