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 )

First Received on October 11, 2007. Last Updated on February 12, 2009 History of Changes

Sponsor:	Arpida AG
Information provided by:	Arpida AG
ClinicalTrials.gov Identifier:	NCT00543608

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 II

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

Drug Information available for: Iclaprim Vancomycin Vancomycin hydrochloride

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 Memorial Hospital

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 February 09, 2012