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Could inhaled TB drugs curb the spread of Drug-Resistant tuberculosis?

NCT ID NCT07708779

Disease control Sponsor: University Medical Center Groningen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 1 study tests whether inhaling high doses of the antibiotic isoniazid is safe and tolerable for people with tuberculosis. Eight adults with known drug-sensitive TB will receive single inhaled doses of 200, 600, and 1200 mg, plus one intravenous dose for comparison. Researchers will monitor lung function and side effects to determine if this approach can deliver high drug concentrations directly to the lungs, potentially reducing how long patients remain contagious.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isoniazid inhalation
What this could lead to
If successful, this approach could allow high-dose isoniazid to be delivered directly to the lungs, potentially shortening the contagious period and reducing the spread of tuberculosis, including drug-resistant strains.
What could go wrong
This is a very early, small phase 1 study with only 8 participants, focused on safety and tolerability. It does not yet test effectiveness, and inhaled antibiotics can cause side effects like coughing or shortness of breath.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Respiratory Aspiration tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Medical Center Groningen

    RECRUITING

    Groningen, Netherlands

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