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

Ventilator-Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00543608
• Other study ID #: ICLA-20-PNE1
• Status: Terminated
• Phase: Phase 2
• First received: October 11, 2007
• Last updated: February 12, 2009
• Start date: November 2007
• Est. completion date: May 2009

Study information

• Verified date: February 2009
• Source: Arpida AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 135
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Health-Care-Associated Pneumonia
• Hospital-Acquired Pneumonia
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-Associated Pneumonia

Intervention

Drug:
• iclaprim

• vancomycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arpida AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin		at test of cure (TOC) visit
Primary	Efficacy: Iclaprim clinical cure rates		at TOC and end of therapy (EOT)
Primary	Safety