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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
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated Enrollment : 900 participants
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 : September 2003
Estimated Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. 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
  2. Days alive and free of parenteral antibiotic use through Day 14
  3. Days alive and free of mechanical ventilation through Day 14

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00118781     History of Changes
Other Study ID Numbers: 09-002
First Posted: July 12, 2005    Key Record Dates
Last Update Posted: July 19, 2005
Last Verified: July 2005

Keywords provided by IntraBiotics Pharmaceuticals:
ventilator-associated pneumonia
VAP
pneumonia
ICU infection

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury