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Photodynamic Treatment of Endotracheal Tubes
This study is not yet open for participant recruitment.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), April 2008
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00529685
  Purpose

The purpose of this study is to look at the safety and effectiveness of a new type of equipment system, which is used to clean the inside of an endotracheal (ET) tube. An ET tube is a thin flexible tube that is placed inside the airway of a patient. The tube is connected to a mechanical breathing machine (respirator), which helps the patient to breathe. This new ET tube cleaning system is called Photodynamic Treatment (PDT). The PDT system uses a light-sensitive liquid solution to coat the endotracheal tube. A light shined on the solution reduces germs that have been found to grow inside the ET tube and cause a serious lung illness (pneumonia). The study will enroll 270 patients, 18-90 years old, who are using a respirator. These patients will be randomly divided into two groups. One group will receive standard care on the ET tube. The other group will receive standard care plus treatment of the ET tube with PDT. Participants may be involved in the study for approximately 2 weeks.


Condition Intervention Phase
Hospital-Acquired Infections
Other: No Intervention
Device: PDT System
Phase I
Phase II

MedlinePlus related topics: Pneumonia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Photodynamic Treatment of Endotracheal Tubes for the Eradication of Microorganisms

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 270
Estimated Study Completion Date: June 2010
Detailed Description:

The leading cause of patient death from hospital-acquired infections is pneumonia. Ventilator-associated pneumonia (VAP) is a common, significant, life threatening infectious disease that occurs in subjects who are intubated with an endotracheal tube and require mechanical ventilation. The primary objective of this study is to evaluate the safety and effectiveness of using photodynamic treatment (PDT) to significantly reduce microbial biofilm (by at least 2 logarithms base 10) that commonly grow inside an endotracheal tube of intubated subjects. Secondary objectives include the following: comparison between PDT treated subjects and those receiving standard-of-care medical treatment (control group) will be made regarding the proportion of subjects who develop tracheobronchitis or VAP during the study period, as documented by fever, new radiographic density, purulent tracheal aspirates, and leukocytosis or leukopenia; comparison of pathogen sensitivities between the treatment and control groups (pathogen sensitivities will be performed on both the endotracheal tube and sputum cultures); comparison of the time to extubation between the treatment and control groups; and comparison of the length of hospitalization between the treatment and control groups. Subjects who will be or who have been recently (within 24 hours) intubated orally with an endotracheal tube and placed on a mechanical respirator are eligible to participate in the study. Subjects will be randomized into either a treatment group or a control group. In the treatment group, the lumen of the subject's endotracheal tube will receive PDT once every 8 hours (3 times per day). The control group will receive no PDT of their endotracheal tube. Treatment group subjects will have a culture sample taken of their endotracheal tube before and after PDT (once per day during the 1st PDT treatment of the day) to determine the effectiveness of PDT to reduce microorganisms. Control group subjects will have their endotracheal tubes cultured for microorganisms once per day at the same time as the treatment group. A sputum culture will be taken from both study groups once per day at the same time of the day. Photodynamic treatment effectiveness will be determined by comparing the quantitative cultures taken before and after PDT within the treatment group as well as comparing the cultures between the treatment and control group. A total of 90 subjects (45 treatment and 45 control) will be studied at each of 3 sites for a grand total of 270 subjects (135 treatment and 135 control). The primary objective will be measured by quantitatively counting the microorganisms present in the endotracheal tube before PDT and after PDT and comparing differences. Quantitative counting will be done using standard microbiologic methodology at each site. Outcomes will also be measured to evaluate the following secondary objectives: quantitative microbiological cultures will be taken from the subject's endotracheal tube in both the control group and treatment group for comparison; a statistical comparison of the incidence of tracheobronchitis and/or VAP will be recorded for both the treatment and the control groups; pathogen sensitivities will be performed and recorded for both the treatment and the control groups including comparisons between both the sputum and endotracheal tube cultures; a statistical comparison of the time from intubation to extubation will be made between the treatment and control groups; and a statistical comparison of the recorded length of hospitalization will be made for both the treatment and the control groups.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained and signed
  • A minimum of 18 years old but no older than 90 years old
  • Medical need for orotracheal intubation and mechanical ventilation or already intubated and ventilated but for no longer than 24 hours
  • Mechanical intubation is required for more than 24 hours

Exclusion Criteria:

  • Subjects intubated for asthma exacerbation
  • Pregnant or lactating females
  • Subjects with head trauma
  • Subjects who have pneumonia as defined by fever, radiographic density, purulent tracheal aspirates, and leukocytosis or leukopenia
  • Subjects who are on pressure controlled ventilation, positive end-expiratory pressure (PEEP) greater than +5 and oxygen requirements greater than 60% throughout the duration of the study
  • Subjects who cannot or are unwilling to provide consent for participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529685

Contacts
Contact: Merrill Biel (612) 871-1144

Locations
United States, Indiana
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
  More Information

Study ID Numbers: 06-0068
Study First Received: September 13, 2007
Last Updated: May 1, 2008
ClinicalTrials.gov Identifier: NCT00529685  
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
photodynamic treatment, ventilator, pneumonia, endotracheal tube

Study placed in the following topic categories:
Cross Infection
Pneumonia

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on January 15, 2009