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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:
ClinicalTrials.gov Identifier:
NCT00543608
First Posted: October 15, 2007
Last Update Posted: February 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Arpida AG
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543608


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

ClinicalTrials.gov Identifier: NCT00543608     History of Changes
Other Study ID Numbers: ICLA-20-PNE1
First Submitted: October 11, 2007
First Posted: October 15, 2007
Last Update Posted: February 13, 2009
Last Verified: February 2009

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
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action