Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients

Completed · Phase 4

Conditions studied: Bacterial Infections

In brief

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.

Key facts

Study ID: NCT00410527
Run by: National Institutes of Health Clinical Center (CC)
People needed: 0
Starts: 2006-08-11
Expected to finish: 2007-05-22
Last updated by the study team: 2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Christiana Care Health Services — Newark, Delaware, United States
University of Miami — Miami, Florida, United States
University of Maryland, Baltimore — Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center — Baltimore, Maryland, 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, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
University of Oklahoma — Oklahoma City, Oklahoma, United States
Brooke Army Medical Center — Fort Sam Houston, Texas, United States
University of Texas, San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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