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

Not Applicable

• Conditions: Z94.2; J22; Lung transplant status; Unspecified acute lower respiratory infection

• Registration Number: DRKS00019225
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-18
• Study Completion: 2020-08-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

No provided informed consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to test result notification of DNA-based testing in comparison to standard cultures

Secondary Outcome Measures

Name	Time	Method
- Time from sampling to test initiation of DNA-based testing in comparison to standard cultures<br>- Time to pathogen isolation of DNA-based testing in comparison to standard cultures<br>- Time to treatment modification based on pathogen isolation of DNA-based testing in comparison to standard cultures<br>- 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<br>- 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<br>- Positive and negative agreement of DNA-based testing in comparison to the final diagnosis of lower respiratory tract infection<br>- Hospilisation and days spent in the hospital<br>- Cost estimation mPCR vs conventional diagnostics<br>- Number of treatment modifications (as a result of mPCR or conventional testing)