Trial of Iseganan in Prevention of Ventilator-Associated Pneumonia - Full Text View

Sponsored by:	IntraBiotics Pharmaceuticals
Information provided by:	IntraBiotics Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00118781

Purpose

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

MedlinePlus related topics: Pneumonia

Drug Information available for: Iseganan Iseganan Hydrochloride

U.S. FDA Resources

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

Further study details as provided by IntraBiotics Pharmaceuticals:

Primary Outcome Measures:

The primary objectives of this trial are to evaluate the safety and efficacy of iseganan when administered to intubated patients receiving mechanical ventilation.

Secondary Outcome Measures:

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

Estimated Enrollment:	900
Study Start Date:	September 2003
Estimated Study Completion Date:	June 2004

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Greater than or equal to 18 years of age
Orally/nasally intubated and receiving mechanical ventilation for <24 hours prior to scheduled randomization and administration of the first dose of Study Drug, and in the judgment of the attending physician, expected to remain intubated and mechanically ventilated for at least 48 hours
Expected to survive for at least 21 days and to remain at the investigational site and not transferred to another institution while intubated during the 21-day study period
Willing and able to provide written informed consent, or if unconscious or have altered sensorium, have a surrogate provide written informed consent as approved by the institution
Negative pregnancy test within 7 days prior to randomization if a female of childbearing potential (Negative pregnancy test results [urine or serum] obtained for reason other than the purposes of this study are acceptable.)

Exclusion Criteria:

Current diagnosis of pneumonia (Patients currently receiving antibiotics for treatment of pneumonia and patients who meet the study definition of clinically defined pneumonia at the time of screening will be excluded.)
Absolute neutrophil count less than 1000/mm3
Human immunodeficiency virus infection with a last known CD4 count less than 500/mm3
Recipient of organ transplantation and receiving immunosuppressive therapy
Current hematologic malignancy
Previously documented cystic fibrosis
Severe cranio-facial trauma or other medical condition expected to require imminent tracheostomy
Patient, patient’s family and/or physician not in favor of aggressive medical management or presence of an advanced directive to withhold life-sustaining treatment
Moribund state or expected to survive less than 21 days due to an uncorrectable medical condition
Participation in a clinical trial of any unlicensed drug, biologic or device within 30 days prior to the first dose of study drug
Concurrent participation in a clinical trial of any unlicensed drug, biologic or device.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118781

Locations

United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

IntraBiotics Pharmaceuticals

Investigators

Study Chair:

Marin Kollef, MD

Barnes-Jewish Hospital, Washington University School of Medicine

More Information

Study ID Numbers:	09-002
Study First Received:	July 1, 2005
Last Updated:	July 11, 2005
ClinicalTrials.gov Identifier:	NCT00118781
Health Authority:	United States: Food and Drug Administration

Keywords provided by IntraBiotics Pharmaceuticals:

ventilator-associated pneumonia
VAP
pneumonia
ICU infection

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009