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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00543608

Enrollment

135

Registered

2007-10-15

Start date

2007-11-30

Completion date

2009-05-31

Last updated

2009-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

pneumonia, nosocomial pneumonia

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.

Interventions

DRUGiclaprim

DRUGvancomycin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026