THERMotherapy Against Persistent Bacterial LUNG Infections

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChronic Obstructive Pulmonary Disease Trial Network, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Allergy to lidocaine and/or midazolam

Contraindications to bronchoscopy

Previous severe laryngospasm (intubation requiring)

Pregnancy/breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thermotherapy/sauna bath

    Other intervention

    Thermotherapy/sauna bath

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Thermotherapy/sauna bathExperimental treatment 1 intervention
Group B: No thermotherapy/sauna bathNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of days from baseline without antibiotic treatment against pulmonary infection

This is a measure of infectious exacerbations.

Time frame
6 months

Secondary outcomes

1

Number of hospitalizations for all causes or death within 6 months

Time frame
6 months
2

Changes in antibiotic usage

Time frame
6 months
3

Number of antibiotic treatment regimes within 6 months

Time frame
6 months
4

Eradication of the cultured bacteria at baseline, defined by a) absence of the trial inclusion bacteria or b) the participant cannot expectorate dure to dry airways.

Absence of bacteria, which lead to inclusion, is measured by a min. of 3 consecutive expectorates with a min. of 24 hours in between.

Time frame
6 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: