Status:
TERMINATED
Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (CP...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Subject, or legal representative, has given written informed consent.
- Subject has developed a new pulmonary infiltrate after ICU admission (confirmed by radiology).
- Subject has been hospitalized at least three days.
- CPIS \</= 6.
- 18 years of age or older.
Exclusion
- Burn patients.
- Cystic fibrosis patients.
- Bone marrow or solid organ transplant patients.
- Neutropenia from any cause (absolute neutophil 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 carbapenem (e.g., imipenem).
- On systemic antibiotics for more than 7 consecutive days during the previous 30 days.
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00307099
Start Date
October 1 2006
End Date
February 1 2007
Last Update
June 7 2013
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
2
Christiana Care Health Services
Newark, Delaware, United States, 19718-2200
3
University of Miami
Miami, Florida, United States, 33136
4
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201