Trial of Iseganan in Prevention of Ventilator-Associated Pneumonia

Sponsor

IntraBiotics Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00118781

Collaborator

(none)

900

Enrollment

Location

Duration (Months)

100

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: iseganan hydrochloride	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

Randomized, Double-Blind, Placebo-Controlled, Multinational Phase 3 Trial Of Iseganan In Prevention Of Ventilator-Associated Pneumonia

Study Start Date :

Sep 1, 2003

Study Completion Date :

Jun 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.