Published ahead of print on September 28, 2005, doi:10.1164/rccm.200504-656OC Am. J. Respir. Crit. Care Med., Volume 173, Number 1, January 2006, 91-97 A more recent version of this article appeared on January 1, 2006
Submitted on April 26, 2005 A Randomized Double-blind Trial of Iseganan in Prevention of Ventilator-Associated PneumoniaMarin H Kollef1*,1 Washington University School of Medicine, St. Louis, MO, USA, 2 University of Geneva Hospitals, Geneva, Switzerland, 3 Hospital Universitario Principe de Asturias, Alcala de Henares, Madrid, Spain, 4 Hopital Pitie-Salpetriere, Paris, France, 5 Hopital Europeen Georges Pompidou, Paris, France, 6 University Medical Center, Utrecht, The Netherlands, 7 University of Michigan Medical Center, Ann Arbor, MI, USA, 8 University of Washington, Seattle, WA, USA, 9 IntraBiotics Pharmaceuticals, Inc., Mountain View, CA, USA, 10 CHU Angers, Angers, France, 11 Ciutat Sanitaria i Universitaria de Bellvitge, Barcelona, Spain, 12 Hospital Universitario Virgen de Arrixaca, Murcia, Spain * To whom correspondence should be addressed. E-mail: mkollef{at}im.wustl.edu.
Rationale: Iseganan, an antimicrobial peptide, is active against aerobic and anaerobic Gram-positive and -negative bacteria as well as fungi and yeasts. The drug has shown little resistance in vitro and to be safe and well tolerated in 800 cancer patients treated for up to 6 weeks.
Objectives: To determine the efficacy of iseganan for the prevention of ventilator-associated pneumonia (VAP).
Methods: Mechanically ventilated patients in US and Europe were randomized to oral topical iseganan or placebo (1:1) and treated six times a day while intubated for up to 14 days. Patients were eligible if randomized within 24 hours of intubation and estimated to survive and remain mechanically ventilated for Key words: pneumonia, mechanical ventilation, prevention
This article has been cited by other articles:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
48 hours. The primary efficacy endpoint of the study was VAP measured among survivors at day 14.
Measurements and Main Results: 709 patients were randomized and received at least one dose of study drug. The two groups were comparable at baseline except iseganan-treated patients were on average 3 years older. The rate of VAP among survivors at day 14 was 16 percent (45/282) in patients treated with iseganan and 20 percent (57/284) in those treated with placebo (P=0.145). Mortality at day 14 was 22.1 percent (80/362) in the iseganan group compared to 18.2 percent (63/347) in the placebo group (P=0.206). No pattern of excess adverse events in the iseganan group compared to placebo was observed.
Conclusions: Iseganan is not effective in improving outcome in patients on prolonged mechanical ventilation.
