- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03312829
FINDpath: Fast I(n)Dentification of PATHogens (FINDpath)
Team Sepsis: Fast I(n)Dentification of PATHogens (FINDPATH)
Study Overview
Status
Conditions
Detailed Description
The trial design is a pilot observational feasibility study within three intensive care units at the Hamilton General Hospital, which is composed of both medical and surgical patient populations where waived consent has been confirmed and approved by the Hamilton Integrated Research Ethics Board. The study sample will include 50 patients over the age of 16 that will be mechanically ventilated for greater than 48 hours with no antibiotic use for the past 24 hours and meet the Johanson Criteria for Ventilator Associated Pneumonia (VAP) as the gold standard for diagnosis still remain controversial. This Johanson criteria maintains patients must have 2 out of three criteria to be enrolled in the study and that criteria includes either a leukocyte count >12,000/mm³ , Fever >38.0ºC and/or a new onset of purulent endotracheal secretions or change in the character of sputum. Chest x-rays for examination of a new or progressing infiltrate will be assessed but will not be used for initial inclusion criteria but possibly in the conclusions when attempting to differentiate VAP from VAT.
Recruitment of eligible patients maintains the need for daily screening of patients which will be done primarily by myself as the co-investigator and from a research assistant through the secure hospital patient data system. However education of the frontline staff particularly nursing, respiratory therapists, physiotherapists and staff physicians who will have direct contact with potential subject is also essential for successful recruitment, coordination and timing of enrollment. I will create and hold education sessions for all frontline staff outlining the purpose of the study, patient enrollment criterion and proper sample collection procedures as well as continual bedside education throughout the course of the study to ensure all staff will have the information to identify potential study patients.
Once patients are identified as meeting criteria for enrollment, the research assistant will be notified at which time the frontline staff will retrieved a premade package for the sample collection. Using a sterile catheter and a clean technique, two separate tracheal aspirates will be acquired from the subject and placed in their specialized clinical or research sputum trap. To acquire two samples, sterile saline irrigation will be permitted and if needed the splitting of the specimen into the separated collection traps. Concurrently a tube of blood as well as one set of blood cultures from an established indwelling access (either central line, arterial line or peripheral blood draw) will be drawn. Clinical lab labels will be placed on one sputum sample and the set of blood cultures and sent routinely to the microbiology lab. The research lab bag will contain the second sputum sample and blood tube labelled with patient identification number and the time of sample collection. To ensure the ability of culturing for anaerobic bacteria in the research laboratory, an anaerobic pack will be placed in the research sample bag with the sputum sample and blood tube as well as a damp paper towel. The sample bag will then be voided of air and sealed. The research bag is labelled as well with patient identification number and date/time of sample collection which is then sent to the clinical microbiology lab. The clinical laboratory is then notified of the incoming research sample which will need to be transported to the research laboratory via established laboratory transportation protocols. Once the sample is sent, the co-investigator is notified again and clinical data (leukocytes, hemoglobin, platelets, arterial blood gases, temperature, Glasgow coma scale, oxygen requirements, high/low respiratory rate, heart rate, and blood pressure) for the day of collection and for the following six days including complete ICU antibiotic usage, extubation date and final patient outcome after 30 days can be collected and entered into a secure RedCap database. Communication to the research laboratory will be the responsibility of the co-investigator to ensure samples have arrived and can be plated in the time set out within the study protocol. Transportation of the samples are available from 0700 until 2000 Monday through Sunday so identification of potential enrollment , and collection of samples will be encouraged during these times to ensure successful arrival and processing of samples at the research laboratory.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L2L 2X2
- Hamilton Health Sciences - General Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age greater than 16yrs
- ICU patients at the General site with a suspected tracheobronchitis or VAP
- Ventilated for greater than 48 hours
- No antibiotics for 24 hours prior to collection of specimens
Exclusion Criteria:
- Hopeless prognosis
- Have received antibiotics 24 hours prior to collection of specimens
- Previously enrolled in FINDPATH
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of eligible patients recruited by front line respiratory and nursing staff
Time Frame: 12 months
|
Staff identify and enrolled 80% of eligible patients
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between clinical lab and research laboratory for pathogen identification
Time Frame: 18 months
|
What pathogens are identified by the research lab that are not cultured in the clinical laboratory
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with ventilator specific outcomes according to Ventilator Associated Pneumonia guidelines
Time Frame: 24 months
|
Morbidity and Mortality at 60 days
|
24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alison Fox-Robichaud, MD, Hamilton Health Sciences; McMaster University
- Principal Investigator: Stephanie Rotella, BSc, RRT, Hamilton Health Sciences Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FINDpath14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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