DNA-based testing of BAL in suspected lower respiratory tract infection after lung transplantation

DNA-based testing of BAL in suspected lower respiratory tract infection after lung transplantation - DBATE-IT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00019225

Enrollment

Registered

2019-11-18

Start date

2019-11-04

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Z94.2 J22

Interventions

Group 1: Rapid multiplex PCR in addition to standard testing of BAL (culture and viral tests)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. patients after lung transplantation (single, double or combined) 2. Patient presents to the Post-Lung-Tx outpatient clinic (During regular working hours) as an emergency visit 3. Suspicion of lower respiratory tract infection as defined by at least 2 out of a) new or progressive pulmonary opacities b) hypoxemia (SpO2/SaO2 <92% or capillary pO2 < 60 mmHg) c) temperature of 38 o C or above within 7 days d) new onset or increasing productive cough e) reduction of forced expiratory volume in 1 sec (FEV1) of 10% or more compared to last outpatient spirometry measurement f) CRP of 5 mg/l or above

Exclusion criteria

Exclusion criteria: No provided informed consent

Design outcomes

Primary

Measure	Time frame
Time to test result notification of DNA-based testing in comparison to standard cultures	—

Secondary

Measure	Time frame
- Time from sampling to test initiation of DNA-based testing in comparison to standard cultures - Time to pathogen isolation of DNA-based testing in comparison to standard cultures - Time to treatment modification based on pathogen isolation of DNA-based testing in comparison to standard cultures - Cohen´s kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of lower respiratory tract infection - Positive and negative agreement, sensitivity and odds ratio of any pathogen isolation DNA-based testing vs. standard cultures in comparison to the final diagnosis of lower respiratory tract infection - Positive and negative agreement of DNA-based testing in comparison to the final diagnosis of lower respiratory tract infection - Hospilisation and days spent in the hospital - Cost estimation mPCR vs conventional diagnostics - Number of treatment modifications (as a result of mPCR or conventional testing)	—

Measure

Time frame

- Time from sampling to test initiation of DNA-based testing in comparison to standard cultures - Time to pathogen isolation of DNA-based testing in comparison to standard cultures - Time to treatment modification based on pathogen isolation of DNA-based testing in comparison to standard cultures - Cohen´s kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of lower respiratory tract infection - Positive and negative agreement, sensitivity and odds ratio of any pathogen isolation DNA-based testing vs. standard cultures in comparison to the final diagnosis of lower respiratory tract infection - Positive and negative agreement of DNA-based testing in comparison to the final diagnosis of lower respiratory tract infection - Hospilisation and days spent in the hospital - Cost estimation mPCR vs conventional diagnostics - Number of treatment modifications (as a result of mPCR or conventional testing)

—

Countries

Germany

Contacts

Public ContactBenjamin Seeliger

Medizinische Hochschule Hannover Klinik für Pneumologie

seeliger.benjamin@mh-hannover.de0511-532-4681

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026