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

Phase 2

Terminated

• Conditions: Hospital-Acquired Pneumonia; Ventilator-Associated Pneumonia; Health-Care-Associated Pneumonia
• Interventions: Drug: iclaprim; Drug: vancomycin

• Registration Number: NCT00543608
• Lead Sponsor: Arpida AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Study Start: 2007-11
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-13
• Primary Completion: 2009-04
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	iclaprim	Dose 1 iclaprim
2	iclaprim	Dose 2 iclaprim
3	vancomycin	vancomycin

Primary Outcome Measures

Name	Time	Method
Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin	at test of cure (TOC) visit
Efficacy: Iclaprim clinical cure rates	at TOC and end of therapy (EOT)
Safety