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Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU

NCT00307099 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2013-06-07

No results posted yet for this study

Summary

This study will enroll 460 subjects who have new pulmonary infiltrates during their ICU stay and who are at low risk of having pneumonia, as determined using the Clinical Pulmonary Infection Score (CPIS). The study is designed to determine whether 3 days of antibiotic treatment with meropenem (with or without coverage for MRSA) for ICU subjects diagnosed with new pulmonary infiltrates can reduce the emergence of anti-microbial-resistant organisms and the isolation of a potential pathogen compared to a standard course of antibiotic therapy (minimum of 8 days of therapy with antibiotics of the primary care team's choosing). Subjects will be randomly placed in either the meropenem group or standard antibiotic therapy group. The study will also examine whether short-course therapy reduces hospital length of stay and hospital cost, without having a negative effect on subject morbidity and mortality.

Conditions

Interventions

DRUG

Meropenem

Meropenem 1 gram intravenously every 8 hours for 3 days (9 doses), then an additional 5 days if the Clinical Pulmonary Infection Score is greater than 6.

DRUG

Standard antibiotic therapy

Standard intravenous antibiotic therapy for a minimum of 8 days.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00307099 on ClinicalTrials.gov