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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00543608
Other study ID # ICLA-20-PNE1
Secondary ID
Status Terminated
Phase Phase 2
First received October 11, 2007
Last updated February 12, 2009
Start date November 2007
Est. completion date May 2009

Study information

Verified date February 2009
Source Arpida AG
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 135
Est. completion date May 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
iclaprim

vancomycin


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Arpida AG

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin at test of cure (TOC) visit
Primary Efficacy: Iclaprim clinical cure rates at TOC and end of therapy (EOT)
Primary Safety
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