Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU

NCT00307099 | Terminated Phase 3

• 2 other identifiers: 03-216BAMSG 4-02
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 10

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 (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.

Conditions

Bacterial Infection

Keywords

bacterial diseases

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

• ICU and Hospital length of stay (LOS)

  Through Day 28 (or hospital discharge, if greater)

• Health Economics: The costs will be based on ICU LOS, hospital LOS, antibiotic treatment, and standardized costs related to the treatment of infection-related adverse experiences.

  Through Day 28 (or hospital dischange, if greater)

• Any clinically significant infection, as determined by the subject's primary care team.

  Through Day 28 (or hospital dischange, if greater)

• Mortality rates at Days 14 and 28.

  Days 14 and 28.

Study Arms (2)

Meropenem

EXPERIMENTAL

Meropenem 1 gram intravenously every 8 hours for 3 days (9 doses), then an additional 5 days if the Clinical Pulmonary Infection Score is greater than 6.

Drug: Meropenem

Standard antibiotic therapy

ACTIVE COMPARATOR

Standard intravenous antibiotic therapy for a minimum of 8 days.

Drug: Standard antibiotic therapy

Interventions

Meropenem DRUG

Meropenem 1 gram intravenously every 8 hours for 3 days (9 doses), then an additional 5 days if the Clinical Pulmonary Infection Score is greater than 6.

Meropenem

Standard antibiotic therapy DRUG

Standard intravenous antibiotic therapy for a minimum of 8 days.

Standard antibiotic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older.

You may not qualify if:

• 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),
• \. 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).
• \. Unlikely to survive past Day 7 of the study (as determined by the primary care team).
• \. Previous enrollment in this study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0006, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718-2200, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Saint Patricks Hospital and Health Sciences Center

Missoula, Montana, 59802-4008, United States

Location

Roswell Park Cancer Institute - Infectious Diseases

Buffalo, New York, 14263-0001, United States

Location

Akron General Medical Center- Medicine

Akron, Ohio, 44307-2433, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2006
• First Posted: March 27, 2006
• Study Start: October 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: June 7, 2013

Record last verified: 2007-02

Locations

US (10)