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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): Impact on Antimicrobial Resistance, Superinfections, Length of ICU Stay and Hospitalization, and Mortality


Phase 3
18 Years
N/A
Not Enrolling
Both
Bacterial Infection

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Trial Information

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): Impact on Antimicrobial Resistance, Superinfections, Length of ICU Stay and Hospitalization, and Mortality


Intensive care units (ICUs) are the most frequently identified source of nosocomial
infections within the hospital, with infection rates and antimicrobial resistance rates
significantly higher than in the general ward. In one study, antimicrobial use was reported
to be 10 times higher in the ICU compared to antimicrobial use in the general ward. Although
antibiotics are given for a variety of conditions, antibiotics prescribed for respiratory
infections, suspected or proven, account for almost one-half of all antibiotic consumption
in the ICU. Importantly, the use of antimicrobial agents has been identified as a critical
risk factor in the emergence of resistant bacterial infections. By identifying and focusing
on subsets of subjects who are unlikely to have infection and therefore unlikely to benefit
from antibiotics, antibiotic use and the subsequent emergence of antimicrobial-resistant
organisms could be limited. This is a Phase III, multi-center, randomized, open-label study
designed to determine whether 3 days of antibiotic treatment with meropenem (with or without
coverage for MRSA) for ICU subjects diagnosed with new pulmonary infiltrates can reduce the
emergence of antimicrobial-resistant organisms and the isolation of a potential pathogen
compared to a standard course of antibiotic therapy (minimum of 8 days of therapy with
antibiotics of the primary care team's choosing). The primary objective of this study is to
compare risk of resistant infection in the ICU by evaluating the difference in the incidence
of either the emergence of antimicrobial-resistant bacteria or the isolation of a potential
pathogen in ICU subjects who receive short-course empiric antibiotic therapy to ICU subjects
who receive standard antibiotic therapy for the treatment of pulmonary infiltrates (with low
likelihood of having pneumonia). Secondary objectives are to: 1) assess the mortality of
subjects receiving short-course empiric antibiotic therapy compared to standard antibiotic
therapy; 2) assess the ICU length of stay (LOS) in subjects receiving short-course empiric
antibiotic therapy compared to standard antibiotic therapy; 3) assess the hospital LOS in
subjects receiving short-course empiric antibiotic therapy compared to standard antibiotic
therapy; 4) assess the costs of antibiotic therapy in subjects receiving short-course
empiric antibiotic therapy compared to standard antibiotic therapy. The costs will be based
on ICU LOS, hospital LOS, antibiotic treatment, and standard costs related to the treatment
of infection-related adverse experiences; 5) assess the risk of clinically significant
infection in subjects receiving short-course empiric antibiotic therapy compared to standard
antibiotic therapy. This study will enroll 460 subjects 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).


Inclusion Criteria:



1. Subject, or legal representative, has given written informed consent.

2. Subject has developed a new pulmonary infiltrate after ICU admission (confirmed by
radiology).

3. Subject has been hospitalized at least three days.

4. CPIS
5. 18 years of age or older.

Exclusion Criteria:

1. Burn patients.

2. Cystic fibrosis patients.

3. Bone marrow or solid organ transplant patients.

4. Neutropenia from any cause (absolute neutophil count (ANC) 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
carbapenem (e.g., imipenem).

9. On systemic antibiotics for more than 7 consecutive days during the previous 30 days.

10. Received more than 2 doses of systemic antibiotics within the past 24 hours (other
than those used for surgical prophylaxis),

9. 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).

10. Unlikely to survive past Day 7 of the study (as determined by the primary care team).

11. Previous enrollment in this study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Combined measure of either emergence of antimicrobial resistance or isolation of a potential pathogen detected in any positive clinical cultures that are deemed a clinically significant infection

Outcome Time Frame:

Day 0 to day 28 (or hospital discharge, if earlier)

Safety Issue:

Yes

Authority:

United States: Federal Government

Study ID:

03-216

NCT ID:

NCT00307099

Start Date:

October 2006

Completion Date:

February 2007

Related Keywords:

  • Bacterial Infection
  • bacterial diseases
  • Bacterial Infections
  • Lung Diseases, Interstitial

Name

Location

University of OklahomaOklahoma City, Oklahoma  73190
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of MiamiMiami, Florida  33136
University of Maryland Medical CenterBaltimore, Maryland  21201-1595
Christiana Care Health ServicesNewark, Delaware  19713
Washington University in St. LouisSt. Louis, Missouri  63110
Saint Patricks Hospital and Health Sciences CenterMissoula, Montana  59802
South Texas Veterans Health Care SystemSan Antonio, Texas  78229
Roswell Park Cancer Institute - Infectious DiseasesBuffalo, New York  14263-0001
Akron General Medical Center- MedicineAkron, Ohio  44307-2433