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

Lower Respiratory Tract and Lung Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02568358
• Other study ID #: LuTx_Mibi-DNA-1
• Status: Not yet recruiting
• Phase: N/A
• First received: October 2, 2015
• Last updated: October 2, 2015
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Hannover Medical School
• Contact: Nora Drick, MD
• Phone: 0511 532
• Email: drick.nora[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Lower Respiratory Tract and Lung Infections
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No