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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02568358

Enrollment

Registered

2015-10-05

Start date

2015-10-31

Completion date

2016-06-30

Last updated

2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Respiratory Tract and Lung Infections

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.

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.

Interventions

OTHERExperimental Intervention: DNA-based testing of BAL fluid

DNA based testing needs 4.5 hours lab time in addition to standard testing

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	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	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.

Contacts

Primary ContactNora Drick, MD

drick.nora@mh-hannover.de0511 532

Backup ContactHoyer Susanne

hoyer.susanne@mh-hannover.de0511 532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026