Thermotherapy for persistent bacterial lung infections
Thermotherapy Against Persistent Bacterial LUNG Infections
This study is testing if regular heat therapy can help people with chronic lung infections get rid of stubborn bacteria that don’t respond to regular antibiotics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chronic Obstructive Pulmonary Disease Trial Network, Denmark Academic / other |
| Locations | 1 site (Hellerup, Capital Region) |
| Trial ID | NCT05351242 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of frequent thermotherapy in reducing colonizing bacteria in patients with persistent bacterial lung infections. Participants will undergo a minimum of 7 minutes in an environment of at least 85℃, four times a week for six months. The study focuses on individuals with chronic lung diseases who have had multiple positive cultures for specific bacteria over the past two years. The goal is to determine if thermotherapy can help eradicate these infections, which are often resistant to standard antibiotic treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of persistent bacterial lung infections and specific positive cultures.
Not a fit: Patients with severe mental illness, allergies to lidocaine or midazolam, or contraindications to bronchoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel treatment option for patients suffering from persistent bacterial lung infections, potentially improving their quality of life.
How similar studies have performed: While the approach of using thermotherapy is novel for this specific condition, similar studies have explored the use of heat in treating infections, though results may vary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Hellerup, Capital Region
- Herlev and Gentofte University hospital — Hellerup, Capital Region, Denmark (Recruiting)
Study contacts
- Study coordinator: Mohamad I Saeed, MD
- Email: mohamad.isam.saeed.02@regionh.dk
- Phone: +4538673555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.