Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410527
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-12-12
Brief Title:
Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-05-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 teams 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-CC-N231 | None | None | None |