Thermotherapy Against Persistent Bacterial LUNG Infections

NCT05351242 | Recruiting DMC

• 1 other identifier: THERM-A-LUNG
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Diseases, Obstructive; Bronchiectasis; Asthma; Copd; Chronic Obstructive Pulmonary Disease; Chronic Lung Infections

Outcome Measures

Primary Outcomes (2)

• Changes in bacterial growth (measured in cfu/mL) from bronchoalveolar lavage after 6 months

  6 months

• Eradication of the cultured bacteria at baseline, defined by no use of antibiotics the last 14 days at the follow-up assessment after 6 months

  6 months

Secondary Outcomes (9)

• Number of hospitalizations for all causes or death within 6 months

  6 months

• Number of antibiotic treatment regimes within 6 months

  6 months

• Physical performance measured by distance walked over 6 minutes

  6 months

• Changes in FEV1 after 6 months

  6 months

• Changes in BMI after 6 months

  6 months

Study Arms (2)

Thermotherapy/sauna bath

EXPERIMENTAL

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

Other: Thermotherapy/sauna bath

No thermotherapy/sauna bath

NO INTERVENTION

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.

Interventions

Thermotherapy/sauna bath OTHER

Thermotherapy/sauna bath

Thermotherapy/sauna bath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Competent and capable
• FEV1\>1,0 L
• Have had a positive culture from sputum or BAL min. 2 times in the last 24 months for bacteria of the species: Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Staphylococcus aureus, Haemophilus influenzae, Achromobacter xylosoxidans, Klebsiella oxytoca or Klebsiella pneumoniae. In addition, min. 1 positive culture after treatment with antibiotics
• Willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months

You may not qualify if:

• Allergy to lidocaine and/or midazolam
• Contraindications to bronchoscopy
• Previous severe laryngospasm (intubation requiring)
• Pregnancy/breastfeeding
• Severe linguistic problems or inability to give informed consent
• Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others

Sponsors & Collaborators

• Chronic Obstructive Pulmonary Disease Trial Network, Denmark: lead

Study Sites (1)

Herlev and Gentofte University hospital

Hellerup, Capital Region, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Obstructive; Bronchiectasis; Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Mohamad I Saeed, MD

CONTACT

+4538673555; mohamad.isam.saeed.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 28, 2022
• Study Start: January 31, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (1)