Tuberculosis
Conditions
Interventions
All participants receive in sequence one intravenous dose of isoniazide 300 mg
and three inhaled dosies isoniazide inhaled via e-Flow nebulizer in increasing
dosing (200 mg, 600 mg and 1200 mg)
Sponsors
Rijksuniversiteit Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - Patients that are pregnant, or breast feeding - History of adverse events on previous or current INH use - FEV1 450 msec), long-QT syndrome (LQTS) or concurrent use of high risk QTc prolongating drugs (amiodarone, erythromycin (daily dose > 1000 mg) or sotalol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the local tolerability, spirometry will be performed and adverse events will be recorded. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following serum pharmacokinetic parameters will be calculated: AUC0-24 (area under the concentration-time curve 0-24 h post-administration), Cmax (maximum serum concentration), Tmax (time to maximum serum concentration). | — |
Countries
Netherlands
Outcome results
None listed