Trial of Iseganan in Prevention of Ventilator-Associated Pneumonia
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|ClinicalTrials.gov Identifier: NCT00118781|
Recruitment Status : Terminated
First Posted : July 12, 2005
Last Update Posted : July 19, 2005
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Drug: iseganan hydrochloride||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled, Multinational Phase 3 Trial Of Iseganan In Prevention Of Ventilator-Associated Pneumonia|
|Study Start Date :||September 2003|
|Estimated Study Completion Date :||June 2004|
- The primary objectives of this trial are to evaluate the safety and efficacy of iseganan when administered to intubated patients receiving mechanical ventilation.
- The secondary objectives of this trial are to compare patients receiving iseganan to patients receiving placebo on the following: VAP-free survival through Day 21
- Days alive and free of parenteral antibiotic use through Day 14
- Days alive and free of mechanical ventilation through Day 14
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118781
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Study Chair:||Marin Kollef, MD||Barnes-Jewish Hospital, Washington University School of Medicine|