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

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Merrem
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections focused on measuring Antibacterials, Colonization, Infection, Pneumonia, Resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • University of Alabama at Birmingham
  • Christiana Care Health Services
  • University of Miami
  • University of Maryland, Baltimore
  • Johns Hopkins Bayview Medical Center
  • Baltimore VA
  • Washington University School of Medicine
  • St. Patrick Hospital and Health Science Center
  • Roswell Park Cancer Institute
  • University of Oklahoma
  • Brooke Army Medical Center
  • University of Texas, San Antonio

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 12, 2006
Last Updated
June 30, 2017
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00410527
Brief Title
Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients
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 Type
Interventional

2. Study Status

Record Verification Date
May 22, 2007
Overall Recruitment Status
Completed
Study Start Date
August 11, 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 22, 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
Antibacterials, Colonization, Infection, Pneumonia, Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Merrem

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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. 18 years of age or older. EXCLUSION CRITERIA: 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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Baltimore VA
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
St. Patrick Hospital and Health Science Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
University of Texas, San Antonio
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9114149
Citation
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.
Results Reference
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Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients

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