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Sponsored by: |
IntraBiotics Pharmaceuticals |
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Information provided by: | IntraBiotics Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00118781 |
This is a multinational, double-blind, placebo-controlled trial designed to assess whether iseganan, applied topically to the oral cavity, can prevent ventilator-associated pneumonia among patients who are intubated and mechanically ventilated and survive for up to 14 days.
Condition | Intervention | Phase |
---|---|---|
Pneumonia |
Drug: iseganan hydrochloride |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled, Multinational Phase 3 Trial Of Iseganan In Prevention Of Ventilator-Associated Pneumonia |
Estimated Enrollment: | 900 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | June 2004 |
Patients will be randomized and receive their first dose of Study Drug within 24 hours of oral/nasal intubation and the initiation of mechanical ventilation. The Study Period will begin with the first administration of Study Drug (Study Day 1). Three mL of Study Drug (9 mg iseganan or matching placebo) will be applied to all visible surfaces in the oral cavity and the oral portion of the endotracheal tube (for non-tracheostomy patients) every 4 hours through Study Day 14, or until the diagnosis of microbiologically-confirmed pneumonia (based on central laboratory results) or extubation, whichever occurs first.
All patients will be evaluated for clinically defined pneumonia at least once daily and, if diagnosed, blood specimens will be collected and cultured, and a bronchoscopic alveolar lavage (BAL) specimen (for intubated patients) or a respiratory secretion specimen (for extubated patients) will be obtained PRIOR to initiating or changing any systemic antimicrobial therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Barnes-Jewish Hospital | |
St. Louis, Missouri, United States, 63110 |
Study Chair: | Marin Kollef, MD | Barnes-Jewish Hospital, Washington University School of Medicine |
Study ID Numbers: | 09-002 |
Study First Received: | July 1, 2005 |
Last Updated: | July 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00118781 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ventilator-associated pneumonia VAP pneumonia ICU infection |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases |
Pneumonia, Ventilator-Associated Cross Infection Pneumonia |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Infection |
Pneumonia, Ventilator-Associated Cross Infection Pneumonia |