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

Condition(s) targeted: Hospital-Acquired Pneumonia; Ventilator-Associated Pneumonia; Health-Care-Associated Pneumonia

Intervention: iclaprim (Drug); vancomycin (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Arpida AG

Official(s) and/or principal investigator(s):
David Willms, MD, Principal Investigator, Affiliation: Sharp HealthCare

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.

Official title: Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia Suspected or Confirmed to be Due to Gram-Positive Pathogens

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin

Efficacy: Iclaprim clinical cure rates

Safety

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: November 2007
Last updated: February 12, 2009