Can a new pill shorten tuberculosis treatment?

NCT ID NCT04044001

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
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests an experimental antibiotic called BTZ-043 in adults with newly diagnosed, drug-sensitive pulmonary tuberculosis. Participants take the drug by mouth once daily for 14 days, and researchers compare it to a standard combination treatment. The main goal is to check whether BTZ-043 is safe and tolerable, while also measuring how well it kills TB bacteria in the sputum. The study is early-stage and open-label, meaning both participants and researchers know which treatment is given.

What this could mean

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

Active substance
BTZ-043, an experimental antibiotic tablet taken by mouth once daily for 14 days
What this could lead to
If BTZ-043 proves safe and kills TB bacteria quickly, it could become a new, shorter treatment option for drug-sensitive tuberculosis.
What could go wrong
This is an early-stage trial with a small number of participants, so the drug may not work as hoped or may cause side effects. Results will need confirmation in larger studies.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

78 people

The number who actually took part.

Started

Nov 2019

Finished

May 2022

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 to 64 years

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.

General inclusion criteria: 1. Provide written, informed consent prior to all trial-related procedures including HIV testing. 2. Understand and willing to comply with the study procedures. 3. Male or female adults, aged 18 up to and including 64 years. 4. Body weight ≥ 40 kg. 5. Participants are either unable to conceive/father children AND/OR they will be using two effective methods of contraception, including methods used by the patient's sexual partner(s). At least one to be a barrier method. Disease-specific inclusion criteria: 6. Newly diagnosed, previously untreated, drug-susceptible pulmonary TB 7. Chest X-ray which is consistent with TB 8. Ability to produce an adequate volume of sputum (at least 10ml estimated overnight production) 9. ≥ 1 sputum sample from concentrated sputum positive for acid-fast bacilli on microscopy (at least 1+ on the International Union Against Tuberculosis and Lung Disease/World Health Organization (IUATLD/WHO) scale) from either a spot sputum or overnight sputum sample. General exclusion criteria: 1. Poor general condition, where delay in treatment cannot be tolerated or death within three months is likely, as assessed by the investigator. 2. The patient is pregnant or breast-feeding. Disease-specific exclusion criteria: 3. The patient is infected with HIV. 4. The patient has a known intolerance to any of the study drugs or concomitant disorders or conditions for which study drugs or standard TB treatment are contraindicated. 5. Treatment with any other investigational drug within 1 month prior to enrolment or enrolment into other clinical (intervention) trials during participation. 6. The patient has a history of or current evidence of clinically relevant cardiovascular metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy or any other condition, that will influence treatment response, study adherence or survival in the judgement of the investigator, especially: 1. Clinically significant evidence of severe TB (e.g. miliary TB, TB meningitis, excluding limited lymph node involvement) 2. Serious lung conditions other than TB or significant respiratory impairment in the discretion of the investigator 3. Neuropathy, epilepsy or significant psychiatric disorder 4. Any diabetes mellitus 5. Cardiovascular disease, such as myocardial infarction, heart failure, coronary heart disease, arrhythmia, tachyarrhythmia, or pulmonary hypertension 6. Current or history of hypertension (systolic blood pressure \>135 mmHg and/or diastolic blood pressure of \>85 mmHg) AND/OR ever received antihypertensive treatment) 7. Long QT syndrome or family history of long QT syndrome or sudden death of unknown or cardiac-related cause 8. Alcohol or other drug abuse, that is sufficient to significantly compromise the safety or cooperation of the patient, includes substances prohibited by the protocol, or has led to significant organ damage, at the discretion of the investigator Laboratory exclusion criteria at screening: 7. Serum amino aspartate transferase (AST) and/or alanine aminotransferase (ALT) activity \>2x the upper limit of normal (ULN) 8. serum alkaline phosphatase (ALP) or y-glutamyl transferase (GGT) \> 2x the ULN 9. serum total bilirubin level \>1.5 times the ULN 10. estimated creatinine clearance (eCrCl) using the Cockcroft and Gault formula level lower than 60 mls/min 11. haemoglobin level \<8.0 g/dL 12. platelet count \<100,000/mm3 13. serum potassium below the lower level of normal (LLN) for the laboratory ECG-specific exclusion criteria: 14. corrected QT interval (QTc)F of \> 450 milliseconds (ms) 15. Atrioventricular (AV) block with PR interval \> 200 ms 16. QRS complex \> 120 ms 17. any other changes in the ECG that are clinically relevant as per discretion of the investigator Restricted medication: 18. Treatment with drugs active against Mycobacterium Tuberculosis (MTB) within the last 3 months prior to screening 19. Requires medication as included in the following drug classes within 2 weeks prior to the first dose of study treatment: * medication that prolongs the QTc interval * Cytochrome P450 (CYP450) inhibitors or inducers, including grapefruit containing foods / beverages and St. John's Wort * Antacids or antipeptic drugs (antacids, H2 blockers, proton pump inhibitors)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • TASK Applied Sciences Clinical Research Centre

    Cape Town, 7530, South Africa

  • University of Cape Town Lung Institute (UCTLI)

    Cape Town, 7700, South Africa

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