Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients
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)
2 other identifiers
interventional
N/A
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2006
Shorter than P25 for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 11, 2006
CompletedFirst Submitted
Initial submission to the registry
December 12, 2006
CompletedFirst Posted
Study publicly available on registry
December 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2007
CompletedJuly 2, 2017
May 22, 2007
December 12, 2006
June 30, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- Subject, or legal representative, has given written informed consent.
- Subject has developed a new pulmonary infiltrate (confirmed by radiology), after ICU admission.
- Subject has been hospitalized at least 3 days.
- CPIS less than or equal to 6.
- years of age or older.
You may not qualify if:
- Subjects who meet any of the following criteria are ineligible for participation in the study:
- Burn patients.
- Cystic fibrosis patients.
- Bone marrow or solid organ transplant patients.
- Neutropenia from any cause (absolute neutrophil count (ANC) \< 500), or likely to become neutropenic within 7 days.
- Known or suspected Human Immunodeficiency Virus (HIV) infection (HIV test is not required).
- Suspected or proven extrapulmonary infection site requiring antibiotic therapy.
- History of anaphylaxis to penicillin or cephalosporins.
- History of anaphylaxis to meropenem (any component of the formulation), or other carbapenems (e.g., imipenem).
- On systemic antibiotics for more than 7 consecutive days during the previous 30 days.
- Received more than two doses of systemic antibiotics within the past 24 hours (other than those used for surgical prophylaxis).
- 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.)
- On mechanical ventilation for \> 7 consecutive days during the previous 30 days.
- Unlikely to survive past Day 7 of the study (as determined by the primary care team).
- Previous enrollment in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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
University of Maryland, Baltimore
Baltimore, Maryland, 21201-1595, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, 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
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
University of Texas, San Antonio
San Antonio, Texas, United States
Related Publications (1)
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. doi: 10.1093/clinids/24.2.211.
PMID: 9114149BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 12, 2006
First Posted
December 13, 2006
Study Start
August 11, 2006
Study Completion
May 22, 2007
Last Updated
July 2, 2017
Record last verified: 2007-05-22