Title
Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia
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
Phase
Phase 2Lead Sponsor
Arpida AGStudy Type
InterventionalStatus
TerminatedIndication/Condition
Hospital-Acquired Pneumonia Ventilator-Associated Pneumonia Health-Care-Associated PneumoniaIntervention/Treatment
iclaprim vancomycin ...Study Participants
135The 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.
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: hospitalization for at least two days within 90 days of the current infection, residence in a nursing home or long-term care facility, 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.
