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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014