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A Phase I Study Investigating the Local Tolerability and Pharmacokinetics of Isoniazid (INH) Inhalation by Wet Nebulization in Patients With Tuberculosis

RecruitingPhase 1Ages 18 Years - anyAllUniversity Medical Center Groningen
NCT07708779 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: To halt the global tuberculosis (TB) crisis, and particular the ongoing threat of drug-resistant TB (DR-TB), it is essential to reduce transmission. This could be done by shortening the period that patients with pulmonary TB secrete viable bacilli, and are therefore contagious to others, by prompt initiation of effective treatment. Pulmonary administration of anti-TB drugs might play an important role since it yields higher local concentrations and lower systemic concentrations compared to systemic (oral or parenteral) administration. Isoniazid (INH) has very high bactericidal activity and is one of the most effective drugs in the treatment of TB. Although the occurrence of mutations leading to resistance to INH at systemic concentrations has hindered the use of this drug, INH can still be effective when administered in a high concentration at the site of infection even in ca

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years and older * Diagnosis of TB with known drug susceptibility, either by culture or molecular testing * Clinically stable or improving after at least 2 weeks of effective TB treatment * Obtained written informed consent Exclusion Criteria: * Patients that are pregnant, or breast feeding * History of adverse events on previous or current INH use * FEV1 \< 30% predicted * Concurrent use of corticosteroids in varying dose (a stable dose one week before participating and during the study is allowed). * Concurrent use of aluminium containing medicines (i.e. antacids) * Concurrent use of carbamazepine, phenytoin or theophylline Additionally, a potential subject with DS-TB (eliciting switch to levofloxacin) who meets any of the following criteria will be excluded from participation in this study: * History of epilepsy * History of adverse events on previous levofloxacin or other fluoroquinolone use * Risk of QTc prolongation (prolonged QTc-interval (\>450 msec), long-QT syndrome (LQTS) or concurrent use of high risk QTc prolongating drugs (amiodarone, erythromycin (daily dose \> 1000 mg) or sotalol)
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What it tests

  • Isoniazid
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Where

1 site
University Medical Center Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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