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)
18 Years
N/A
Both
Bacterial Infections
Trial Information
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.
Inclusion Criteria
- INCLUSION CRITERIA:
The study will be limited to the medical, surgical, neurosurgical, trauma, and general
ICUs of the participating institutions. Burn ICUs are not eligible for this study.
Subjects who meet all of the following criteria are eligible for enrollment into the
study:
1. Subject, or legal representative, has given written informed consent.
2. Subject has developed a new pulmonary infiltrate (confirmed by radiology), after ICU
admission.
3. Subject has been hospitalized at least 3 days.
4. CPIS less than or equal to 6.
5. 18 years of age or older.
EXCLUSION CRITERIA:
Subjects who meet any of the following criteria are ineligible for participation in the
study:
1. Burn patients.
2. Cystic fibrosis patients.
3. Bone marrow or solid organ transplant patients.
4. Neutropenia from any cause (absolute neutrophil count (ANC) < 500), or likely to
become neutropenic within 7 days.
5. Known or suspected Human Immunodeficiency Virus (HIV) infection (HIV test is not
required).
6. Suspected or proven extrapulmonary infection site requiring antibiotic therapy.
7. History of anaphylaxis to penicillin or cephalosporins.
8. History of anaphylaxis to meropenem (any component of the formulation), or other
carbapenems (e.g., imipenem).
9. On systemic antibiotics for more than 7 consecutive days during the previous 30 days.
10. Received more than two doses of systemic antibiotics within the past 24 hours (other
than those used for surgical prophylaxis).
11. Pregnant or lactating. (Women of childbearing potential must have a negative serum or
urine pregnancy test within the 7 days prior to the first dose of antibiotics.)
12. On mechanical ventilation for > 7 consecutive days during the previous 30 days.
13. Unlikely to survive past Day 7 of the study (as determined by the primary care team).
14. Previous enrollment in this study.
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Authority:
United States: Federal Government
Study ID:
999906231
NCT ID:
NCT00410527
Start Date:
August 2006
Completion Date:
May 2007
Related Keywords:
- Bacterial Infections
- Antibacterials
- Colonization
- Infection
- Pneumonia
- Resistance
- Bacterial Infections
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 |
