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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hospital-Acquired Pneumonia
Ventilator-Associated Pneumonia
Health-Care-Associated Pneumonia
 Drug: iclaprim
Drug: vancomycin
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Arpida AG:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 135
Study Start Date: November 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose 1 iclaprim
 Drug: iclaprim
Experimental: 2
Dose 2 iclaprim
 Drug: iclaprim
Active Comparator: 3
vancomycin
 Drug: vancomycin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543608

Sponsors and Collaborators
Arpida AG
Investigators
Principal Investigator: David Willms, MD Sharp HealthCare
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00543608     History of Changes
Other Study ID Numbers: ICLA-20-PNE1
Study First Received: October 11, 2007
Last Updated: February 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Arpida AG:
pneumonia
nosocomial pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
 Vancomycin
Iclaprim
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013