Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections
Intervention: Merrem (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institutes of Health Clinical Center (CC)
Summary
This study will compare two treatment strategies (standard versus short-course antibiotic
therapy) for preventing resistant bacterial infection in patients in the intensive care unit
(ICU). ICUs are the most frequently identified source of hospital-acquired infections. This
study will examine the effectiveness of 3 days of antibiotic treatment in reducing the risk
of developing antimicrobial-resistant bacteria as compared with standard antibiotic therapy
of at least 8 days. It will also determine whether short-course therapy can reduce the
duration and costs of ICU and hospital stays, of antibiotic treatment, and of costs involving
treatment of infection-related problems.
Patients of participating institutions who are in the ICU may be eligible for this study.
Candidates must be 18 years of age or older. They must have been in the hospital for at least
3 days, developed new pulmonary infiltrates (fluid or cells in the airspaces of the lungs)
during their ICU stay and must be at low risk of having pneumonia.
Participants on short-course therapy take antibiotic for 3 days; those receiving standard
therapy take antibiotic for at least 8 days. Both groups receive the treatment intravenously
(through a vein). Sputum specimens are collected at baseline (before starting therapy) and
on days 3, 10, and 28. Throat culture specimens are obtained at baseline and on days 3, 10,
and 28. Nasal and anal or stool samples are collected at baseline and on days 10 and 28.
Cultures of respiratory specimens obtained throughout the study period are examined for
evidence of antimicrobial-resistant bacteria or the isolation of a potential pathogen. All
patients are followed for 28 days after enrollment or until discharge from the hospital.
Clinical Details
Official title: 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)
Study design: Treatment
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama, United States
Christiana Care Health Services, Newark, Delaware 19713, United States
University of Miami, Miami, Florida 33101, United States
Johns Hopkins Bayview Medical Center, Baltimore, Maryland 21224, United States
University of Maryland, Baltimore, Baltimore, Maryland 21201-1595, United States
Baltimore VA, Baltimore, Maryland, United States
Washington University School of Medicine, St. Louis, Missouri, United States
St. Patrick Hospital and Health Science Center, Missoula, Montana 59802, United States
Roswell Park Cancer Institute, Buffalo, New York 14263, United States
University of Oklahoma, Oklahoma City, Oklahoma 73104, United States
University of Texas, San Antonio, San Antonio, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas 78234, United States
Additional Information
Related publications: Archibald L, Phillips L, Monnet D, McGowan JE Jr, Tenover F, Gaynes R. Antimicrobial resistance in isolates from inpatients and outpatients in the United States: increasing importance of the intensive care unit. Clin Infect Dis. 1997 Feb;24(2):211-5.
Starting date: August 2006
Ending date: May 2007
Last updated: May 23, 2007
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