DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
October 2, 2015 updated by: Thomas Fuehner, Hannover Medical School
Lung transplantation (LTx) , DNA-based testing.
Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard testing.
Experimental intervention: DNA-based testing of BAL fluid.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection.
Study Type
Observational
Enrollment (Anticipated)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Lung transplant recipients with suspected non-viral lower respiratory tract infection
Description
Inclusion Criteria:
- patients after lung transplantation (single, double or combined)
- suspicion of non-viral lower respiratory tract infection as defined by at least 2 out of
- new onset of malaise
- new or progressive pulmonary infiltrate
- hypoxemia (SpO2/SaO2 <92% or need for oxygen)
- temperature of 38 o C or above within 7 days
- purulent (yellow or greenish) sputum
- CRP of 30 mg/l or above
- PCT of 0,5 µg/l or above
Exclusion Criteria:
- no informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection
Time Frame: 6 month
|
Cohen's kappa measures the agreement between methods and the final clinical diagnosis.
Both methods (DNA-based testing and standard cultures) will result in isolation of a non-viral pathogen or no isolation of a pathogen.
A final clinical diagnosis will classify patients clinically in two categories as non-viral lower respiratory tract infection or no non-viral lower respiratory tract infection usually made 48-72 hours made after sampling.
Cohen's kappa will be compared between the two methods.
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jens Gottlieb, Prof. Dr., Hannover Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
April 1, 2016
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
October 2, 2015
First Submitted That Met QC Criteria
October 2, 2015
First Posted (Estimate)
October 5, 2015
Study Record Updates
Last Update Posted (Estimate)
October 5, 2015
Last Update Submitted That Met QC Criteria
October 2, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LuTx_Mibi-DNA-1
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.