THERMotherapy Against Persistent Bacterial LUNG Infections

Sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Study ID
NCT05351242
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Thermotherapy/sauna bath — OTHER
    Thermotherapy/sauna bath

Study Details

The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.

Key Dates

First listed
Apr 28, 2022
Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Thermotherapy/sauna bath
    Must go to a sauna (min. Temperature 85℃) min. 4 times a week for 6 months. Each sauna bath must last at least 7 minutes. The intervention patients receive a subscription card for a sauna during the period. Patients will still receive pre-existing treatment
  • No Intervention: No thermotherapy/sauna bath
    Not allowed to go to a sauna for 6 months. Patients who come to do so, by e.g. an oversight, however, remain in the study, to avoid introducing bias. It will be registered as a "protocol violation", but the patient will be included in Intention To Treat analysis and modified Intention To Treat analysis. Patients will still receive pre-existing treatment.

Primary Outcome Measure

Number of days from baseline without antibiotic treatment against pulmonary infection [ Time Frame: 6 months ]

Central Contacts

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