Condition: Tuberculosis · Sponsor: University Medical Center Groningen
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 case of drug resistance. This cannot easily be achieved by oral dosing because of the associated risk of systemic toxicity. However, pulmonary administration of INH may be a solution. The concept of inhalable antimicrobials is not new; for example it is a well-established therapy for the treatment of Pseudomonas aeruginosa infection in cystic fibrosis patients. INH has been used by inhalation before in patients with TB but only up to a dose of 200 mg/day. In this protocol, a local tolerability and pharmacokinetic study of higher doses of INH inhalations will be performed by wet nebulization in p…
This description comes directly from the study's public registry record.
Cynthia Maharani, MD · +31503616161 · c.maharani@umcg.nl
Always discuss trial participation with your own doctor first.
| University Medical Center Groningen | Groningen, Netherlands | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07708779