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

This study has been terminated.
(Trial terminated due to financial resource limitations)
Sponsor:
Information provided by:
Arpida AG
ClinicalTrials.gov Identifier:
NCT00543608
First received: October 11, 2007
Last updated: February 12, 2009
Last verified: February 2009

October 11, 2007
February 12, 2009
November 2007
April 2009   (final data collection date for primary outcome measure)
  • Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin [ Time Frame: at test of cure (TOC) visit ]
  • Efficacy: Iclaprim clinical cure rates [ Time Frame: at TOC and end of therapy (EOT) ]
  • Safety
Efficacy: Clinical cure rate at TOC - comparison of the two iclaprim dosing regimens versus vancomycin b) Efficacy: Iclaprim Clinical cure rates at TOC and EOT c) Safety
Complete list of historical versions of study NCT00543608 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Hospital-Acquired Pneumonia
  • Ventilator-Associated Pneumonia
  • Health-Care-Associated Pneumonia
  • Drug: iclaprim
  • Drug: vancomycin
  • Experimental: 1
    Dose 1 iclaprim
    Intervention: Drug: iclaprim
  • Experimental: 2
    Dose 2 iclaprim
    Intervention: Drug: iclaprim
  • Active Comparator: 3
    vancomycin
    Intervention: Drug: vancomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
135
May 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00543608
ICLA-20-PNE1
Yes
Not Provided
Arpida AG
Not Provided
Principal Investigator: David Willms, MD Sharp HealthCare
Arpida AG
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP