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

Primary Purpose

Hospital-Acquired Pneumonia, Ventilator-Associated Pneumonia, Health-Care-Associated Pneumonia

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
iclaprim
vancomycin
Sponsored by
Arpida AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hospital-Acquired Pneumonia focused on measuring pneumonia, nosocomial pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Dose 1 iclaprim

    Dose 2 iclaprim

    vancomycin

    Outcomes

    Primary Outcome Measures

    Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin
    Efficacy: Iclaprim clinical cure rates
    Safety

    Secondary Outcome Measures

    Full Information

    First Posted
    October 11, 2007
    Last Updated
    February 12, 2009
    Sponsor
    Arpida AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00543608
    Brief Title
    Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Terminated
    Why Stopped
    Trial terminated due to financial resource limitations
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    April 2009 (Anticipated)
    Study Completion Date
    May 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Arpida AG

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hospital-Acquired Pneumonia, Ventilator-Associated Pneumonia, Health-Care-Associated Pneumonia
    Keywords
    pneumonia, nosocomial pneumonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    135 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Dose 1 iclaprim
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Dose 2 iclaprim
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    vancomycin
    Intervention Type
    Drug
    Intervention Name(s)
    iclaprim
    Intervention Type
    Drug
    Intervention Name(s)
    vancomycin
    Primary Outcome Measure Information:
    Title
    Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin
    Time Frame
    at test of cure (TOC) visit
    Title
    Efficacy: Iclaprim clinical cure rates
    Time Frame
    at TOC and end of therapy (EOT)
    Title
    Safety

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: hospitalization for at least two days within 90 days of the current infection, residence in a nursing home or long-term care facility, 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Willms, MD
    Organizational Affiliation
    Sharp HealthCare
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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