Overview

Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU

Status:
Terminated
Trial end date:
2007-02-01
Target enrollment:
0
Participant gender:
All
Summary
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). The study is 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 anti-microbial-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). Subjects will be randomly placed in either the meropenem group or standard antibiotic therapy group. The study will also examine whether short-course therapy reduces hospital length of stay and hospital cost, without having a negative effect on subject morbidity and mortality.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Meropenem
Thienamycins
Criteria
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.