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Can a 4-Month drug cocktail cure TB as well as 6 months?

NCT ID NCT05047055

Cure Sponsor: Tuberculosis Research Centre, India 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers in India are studying whether a 4-month daily regimen that includes moxifloxacin can cure newly diagnosed, microbiologically confirmed pulmonary tuberculosis as effectively as the standard 6-month treatment. The study enrolls 550 adults aged 18 to 65 who have not yet been treated for TB. Participants receive the shorter regimen under India's National TB Elimination Program, and researchers track whether the infection stays cured, how well patients tolerate the drugs, and whether any cases return.

What this could mean

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

Active substance
moxifloxacin added to standard TB drugs (isoniazid, rifampicin, pyrazinamide, ethambutol)
What this could lead to
If it works, a shorter 4-month TB treatment could become standard under India's TB program, cutting treatment time by a third and easing the burden on patients and health systems.
What could go wrong
The regimen may not cure as reliably outside the controlled trial setting, or side effects from moxifloxacin could limit its use. The study follows participants for recurrence, so the full picture takes time to emerge.

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.

Participants

550 people

The number who actually took part.

Started

Mar 2022

Finished

Apr 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

Newly diagnosed adult sputum smear and or CBNAAT positive pulmonary TB patients

Ages

18 to 65 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.

Inclusion Criteria: 1. Age 18 to 65 years 2. At least one sputum smear and or CBNAAT test should be positive for tubercle bacilli 3. Female participants of childbearing potential must have a negative urine pregnancy test at screening. Those who have not undergone permanent sterilisation - tubal ligation or spouse with vasectomy must agree for use of contraceptive measures for birth control - vaginal diaphragm, intrauterine device, condom until treatment completion. 4. Willing to follow the trial procedures 5. Willing to give written informed consent 6. Residing within the study TU Exclusion Criteria: 1. Body weight less than 30 kg 2. Previous anti-TB treatment, if any, should not exceed one month in the past 2 years and more than 7 days in the preceding one month 3. Multidrug resistant TB (MDR-TB) 4. Resistance to isoniazid or rifampicin or quinolone as evidenced by Cartridge based Nucleic acid Amplification test (CBNAAT) and Line probe Assay (LPA) test 5. Associated extra-pulmonary TB except TB superficial lymphadenitis 6. Hepatic or renal disease as evidenced by clinical or biochemical abnormalities- ALT/AST\> 2.5 times ULN or Total bilirubin \>1.2 mg/dl, Serum Creatinine \>1.2 mg/dl, Blood Urea \>43 mg/dl. 7. QTcF\> 450 ms or bundle branch block or heart block on ECG 8. Psychiatric illness 9. Seizure disorder 10. Pregnancy or lactation 11. Those seriously ill as defined by a score of \<50 on Karnofsky scale (Annexure 1)

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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

Contacts and locations

Locations

  • National Institute for Research in Tuberculosis

    Chennai, Tamil Nadu, 600031, India

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