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

Study Overview
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Brief Summary
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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
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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

Conditions
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Hospital-Acquired Pneumonia, Ventilator-Associated Pneumonia, Health-Care-Associated Pneumonia

Intervention / Treatment
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* Drug: iclaprim
* Drug: vancomycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose 1 iclaprim | Drug: iclaprim<br> <br> |
| Experimental: 2<br>Dose 2 iclaprim | Drug: iclaprim<br> <br> |
| Active Comparator: 3<br>vancomycin | Drug: vancomycin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, nosocomial pneumonia