BridgeMD
New treatment option for Tuberculosis
Official title A Phase I Study Investigating the Local Tolerability and Pharmacokinetics of Isoniazid (INH) Inhalation by Wet Nebulization in Patients With Tuberculosis
ClinicalTrials.gov ID: NCT07708779
What this study is testing
What is Isoniazid?
Isoniazid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for tuberculosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.