Evaluation of a patient diary to assess treatment outcome in patients with pulmonary non-tuberculous mycobacterial (NTM) infections
This prospective, multicenter, observational study aims to evaluate whether a simple and inexpensive patient diary can effectively monitor treatment response and detect potential treatment failure in patients with pulmonary nontuberculous mycobacterial (NTM) infections. Currently, monitoring these infections relies primarily on microbiological and radiological assessments, both of which have significant limitations. Microbiological tests can be affected by variable sample quality, intermittent mycobacterial shedding, and contamination, while radiological assessments may be challenging to interpret due to underlying chronic lung conditions and raise concerns about cumulative radiation exposure. As a result, there is a need for a systematic, user-friendly method to track disease progression that reduces reliance on costly, invasive procedures. Although patient diaries have been used in other chronic lung diseases, they have not been systematically studied in pulmonary NTM infections. This study seeks to address this gap by exploring how patient diaries can aid in treatment monitoring and enhance assessments of health-related quality of life. The diary-based approach is also expected to reduce the frequency of microbiological and radiological follow-ups, offering potential economic benefits and providing continuous, real-time symptom tracking.
The study aims to enroll 200 participants with pulmonary NTM infections across multiple centers. It will include two cohorts: patients undergoing antimicrobial therapy and those not receiving treatment due to clinical or personal reasons. Participants will document daily symptoms, medication adherence, and notable clinical events in a patient diary. Data will be collected at baseline and during follow-up visits, and microbiological and radiological assessments will be performed in parallel to examine correlations between diary entries, microbiological findings, and radiological outcomes.
We aim to provide valuable insights into the utility of patient diaries for managing pulmonary NTM infections. The findings could improve patient care and reduce the need for frequent, burdensome microbiological and radiological monitoring.
PIs: Dr. Thomas Brehm, Prof. Christoph Lange
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