Randomized, Multi-Center, Comparative Trial of Short-Course Empiric Antibiotic Therapy Versus Standard Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the Intensive Care Unit (ICU)
This study will enroll subjects who have been hospitalized at least three days (on or after
fourth day of hospital stay), 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) can reduce the risk of
colonization with antimicrobial-resistant bacteria or the isolation of a potential pathogen
compared to a standard antibiotic therapy (minimum of 8 days of therapy with antibiotics of
the primary care team's choosing). The study will also examine whether short-course therapy
reduces length of ICU and hospital LOS and costs based on ICU and hospital LOS, antibiotic
treatment, and standardized costs related to the treatment of infection-related adverse
experiences, without having a negative effect on subject mortality or the incidence of
clinically significant infection.
Interventional
Primary Purpose: Treatment
United States: Federal Government
999906231
NCT00410527
August 2006
May 2007
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
University of Oklahoma | Oklahoma City, Oklahoma 73190 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
University of Miami | Miami, Florida 33136 |
Christiana Care Health Services | Newark, Delaware 19713 |
University of Maryland, Baltimore | Baltimore, Maryland 21201-1595 |
University of Texas, San Antonio | San Antonio, Texas 78229-3900 |
Johns Hopkins Bayview Medical Center | Baltimore, Maryland 21224 |
Baltimore VA | Baltimore, Maryland |
St. Patrick Hospital and Health Science Center | Missoula, Montana 59802 |