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DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection

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ClinicalTrials.gov Identifier: NCT02568358
Recruitment Status : Unknown
Verified October 2015 by Thomas Fuehner, Hannover Medical School.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2015
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas Fuehner, Hannover Medical School

Brief Summary:

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.


Condition or disease Intervention/treatment
Lower Respiratory Tract and Lung Infections Other: Experimental Intervention: DNA-based testing of BAL fluid

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.

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
Study Start Date : October 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Experimental Intervention: DNA-based testing of BAL fluid
    DNA based testing needs 4.5 hours lab time in addition to standard testing


Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Bronchoalveolar lavage


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Lung transplant recipients with suspected non-viral lower respiratory tract infection
Criteria

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

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): NCT02568358


Contacts
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Contact: Nora Drick, MD 0511 532 ext 4601 drick.nora@mh-hannover.de
Contact: Hoyer Susanne 0511 532 ext 4601 hoyer.susanne@mh-hannover.de

Sponsors and Collaborators
Hannover Medical School
Investigators
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Principal Investigator: Jens Gottlieb, Prof. Dr. Hannover Medical School
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Responsible Party: Thomas Fuehner, PD Dr. med. Thomas Fühner, Hannover Medical School
ClinicalTrials.gov Identifier: NCT02568358    
Other Study ID Numbers: LuTx_Mibi-DNA-1
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases