Treatment Monitoring for NTM Infections With a Symptom Diary (NTMdiary)

Research Center Borstel

Status: Enrolling

Conditions: Non-Tuberculous Mycobacterial (NTM) Infections

Treatments: Other: Filling in a symptom diary

Study type: Observational

Funder types: Other

Identifiers

NCT07131774

NTMdiary2025-002

Details and patient eligibility

About

The primary aim of the study is to investigate the correlation between patient-reported symptoms recorded in the diary and the microbiological and radiological disease course in patients with pulmonary infections caused by nontuberculous mycobacteria (NTM).

Full description

This prospective observational study investigates the suitability of a symptom diary for assessing disease progression and treatment outcomes in patients with pulmonary infections caused by nontuberculous mycobacteria (NTM). The aim of the study is to correlate the symptoms documented in the diary with microbiological and radiological parameters to gain a better understanding of the disease course and treatment effects. This may contribute to the development of a simpler and non-invasive tool that could improve patients' quality of life and enable more precise monitoring of disease progression.

This multicenter study plans to enroll 200 adult patients with confirmed pulmonary NTM infections who are capable of providing informed consent. Each patient will document daily symptoms - such as cough, body weight, temperature, and other complaints - in a symptom diary over a period of six months. In addition, clinical routine data, including microbiological and radiological findings, will be used without requiring any additional diagnostic procedures.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pulmonary NTM infection according to ATS/IDSA criteria (1)

• Age ≥ 18 years

• Ability to provide informed consent

• Willingness to participate in the study AND

• Clinical decision to initiate antimicrobial therapy as part of routine care

  • Cohort 1 OR

• Clinical decision against antimicrobial therapy as part of routine care

  • Cohort 2

Exclusion criteria

• Lack of ability to provide informed consent
• Language barriers that prevent completion of the diary
• Antimicrobial therapy for the NTM infection already initiated

Trial design

200 participants in 2 patient groups

NTM infection, under therapy

Description:

Patients who have a pulmonary NTM infection according to ATS/IDSA criteria and are receiving antimicrobial therapy (Cohort 1).

Treatment:

Other: Filling in a symptom diary

NTM infection, no therapy

Description:

Patients who have a pulmonary NTM infection according to ATS/IDSA criteria but are not receiving therapy due to a clinical decision or the patient's own choice (Cohort 2).

Treatment:

Other: Filling in a symptom diary