Trial of Iseganan in Prevention of Ventilator-Associated Pneumonia

NCT00118781 | Terminated Phase 2

• 1 other identifier: 09-002
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Keywords

ventilator-associated pneumonia; VAP; pneumonia; ICU infection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

iseganan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• IntraBiotics Pharmaceuticals: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marin Kollef, MD

  Barnes-Jewish Hospital, Washington University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 12, 2005
• Study Start: September 1, 2003
• Study Completion: June 1, 2004
• Last Updated: July 19, 2005

Record last verified: 2005-07

Locations

US (1)