Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours [q12h]) in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arpida AG
• Treatments: Iclaprim; Vancomycin

Criteria

Inclusion Criteria:

• Suspected or confirmed acute bacterial pneumonia due to Gram-positive pathogens in one of the following subgroups:

• hospital-acquired pneumonia (HAP), i.e., pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; or

• ventilator-associated pneumonia (VAP), i.e., pneumonia that arises more than 48 hours after endotracheal intubation; or

• health-care-associated pneumonia (HCAP), i.e., pneumonia diagnosed within 48 hours of hospital admission, in a patient who fulfills at least one of the following criteria:

1. hospitalization for at least two days within 90 days of the current infection,

2. residence in a nursing home or long-term care facility,

3. recipient of intravenous antibiotic therapy, chemotherapy, or wound care within 30 days of the current infection

Exclusion Criteria:

• Acute Physiology and Chronic Health Enquiry (APACHE) II score < 8 or ≥ 25.

• Pneumonia not requiring empiric or targeted treatment effective against Gram-positive pathogens.

• Pulmonary infection due to Gram-positive organisms known to be resistant to either study medication prior to study entry.