- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00543608
Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia
February 12, 2009 updated by: Arpida AG
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
135
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Dose 1 iclaprim
|
|
Experimental: 2
Dose 2 iclaprim
|
|
Active Comparator: 3
vancomycin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
|
|
Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin
Time Frame: at test of cure (TOC) visit
|
at test of cure (TOC) visit
|
Efficacy: Iclaprim clinical cure rates
Time Frame: at TOC and end of therapy (EOT)
|
at TOC and end of therapy (EOT)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Willms, MD, Sharp HealthCare
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Anticipated)
April 1, 2009
Study Completion (Anticipated)
May 1, 2009
Study Registration Dates
First Submitted
October 11, 2007
First Submitted That Met QC Criteria
October 12, 2007
First Posted (Estimate)
October 15, 2007
Study Record Updates
Last Update Posted (Estimate)
February 13, 2009
Last Update Submitted That Met QC Criteria
February 12, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Cross Infection
- Iatrogenic Disease
- Healthcare-Associated Pneumonia
- Pneumonia
- Pneumonia, Ventilator-Associated
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Folic Acid Antagonists
- Vancomycin
- Iclaprim
Other Study ID Numbers
- ICLA-20-PNE1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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