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