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Can higher doses of TB drugs cut treatment time?

NCT ID NCT04694586

Disease control Sponsor: University Hospital, Linkoeping Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This phase II trial is investigating whether higher doses of two tuberculosis (TB) drugs, rifampicin and pyrazinamide, can safely shorten treatment for people with mild to moderate pulmonary TB. The study compares drug levels and safety of this high-dose regimen against the standard treatment. If successful, this approach could lead to shorter, more effective TB therapy.

What this could mean

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

Active substance
High-dose rifampicin and pyrazinamide
What this could lead to
If successful, this could lead to a shorter, more effective treatment for tuberculosis, improving adherence and outcomes.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. High doses of these drugs could increase the risk of side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Started

Nov 2022

Expected to finish

May 2030

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: * Patient 18 years and older * Confirmed pulmonary TB (positive Mtb culture or positive polymerase chain reaction (PCR) Mtb-complex) * Intended to start on first-line TB treatment * HIV negative * BMI \>17 * Written Informed Consent * Women of childbearing potential should agree on adequate contraceptives during treatment period and have a negative pregnancy test prior to treatment initiation Exclusion Criteria: * Not able to provide informed consent/unable to assimilate study information * Concomitant infectious disease that requires treatment * Known allergy to rifamycins, isoniazid, pyrazinamide, ethambutol or history of severe sideeffect to any of the drugs * Drug-induced inflammatory liver diseases in medical history * History of acute liver disease * On-going liver disease including hepatitis and elevated transaminase levels \>x5 upper normal limit * Porphyria * Drug-drug interaction between concomitant drugs and rifampicin that could not be bridged by dose-adjustment of the concomitant drug * Jaundice * Acute gout * Treatment of active TB during the last year * Drug resistance to RIF, INH, PZA or EMB * Miliary TB * Pulmonary TB with smear positivity grade 3 and/or chest X-ray grading equal to advanced TB * TB in the central nervous system * Extrapulmonary TB (outside central nervous system) without pulmonary TB * Pregnancy and breast-feeding * Immunosuppressive condition * Heart failure (NYHA class III and IV) * Renal failure with estimated glomerular filtration rate (eGFR) \<50 mL/min * Dysregulated diabetes mellitus * Alcohol and drug abuse * Weight \<35 kg or \>90 kg * Participation in other clinical trial (investigating a drug) within the last 30 days prior to study inclusion * Person who the investigator, after consultation with the central contact persons of the study, finds by other reason than the above listed not suitable for study participation

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis

As listed by the trial registrant

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

Tuberculosis, pulmonary

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Linköping University Hospital

    Linköping, S-581 85, Sweden

More trials for these conditions

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