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

Arpida

Status and phase: Terminated; Phase 2

Conditions: Ventilator-Associated Pneumonia; Hospital-Acquired Pneumonia; Health-Care-Associated Pneumonia

Treatments: Drug: iclaprim; Drug: vancomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543608

ICLA-20-PNE1

Details and patient eligibility

About

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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 3 patient groups

1

Experimental group

Description:

Dose 1 iclaprim

Treatment:

Drug: iclaprim

2

Experimental group

Description:

Dose 2 iclaprim

Treatment:

Drug: iclaprim

3

Active Comparator group

Description:

vancomycin

Treatment:

Drug: vancomycin