Can a Four-Month TB cure replace six months of treatment?
NCT ID NCT05575518
First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time
Summary
Tuberculosis treatment usually lasts six months, which is hard for patients and health systems to manage. This trial tests whether a four-month regimen using a higher dose of rifampicin, with or without moxifloxacin, can cure drug-susceptible pulmonary TB as reliably as standard treatment. Researchers enroll 414 adults in African populations with high rates of HIV co-infection. They measure whether patients are cured without relapse and track serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an optimized higher dose of rifampicin, with or without moxifloxacin
- What this could lead to
- If it works, a four-month TB regimen could shorten treatment for millions of people and ease the burden on health systems in countries where TB is common.
- What could go wrong
- Shorter regimens can fail if the drugs do not clear the infection completely, and higher doses may cause more side effects. The trial must show the four-month approach works as well as standard treatment in people who also have HIV.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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414 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Sep 2026
- Lead sponsor
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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.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Each patient must meet all the following inclusion criteria prior to enrolment into the trial: 1. The patient has given fully informed, signed written or witnessed oral informed consent for study participation prior to all trial-related procedures, including HIV testing if HIV status is not known. 2. The patient has a diagnosis of pulmonary TB established by Xpert MTB/RIF® result which confirms "low" "medium" or "high" level detection of M tuberculosis and does not detect rifampicin resistance. 1. If the patient has been referred from a clinic at which the pre-screening clinical diagnostic test for TB was an Xpert MTB/RIF® assay done at the trial laboratory, and the full read-out of that result is available, the test does not need to repeated to confirm eligibility. 2. If the patient has been referred from a clinic at which the pre-screening clinical diagnostic test for TB was an Xpert MTB/RIF® assay done at a non-trial laboratory, but the full read-out of that result is available, the test does not need to repeated to confirm eligibility. 3. If the patient has been referred to the study from a clinic from which the full pre-screening clinical diagnostic Xpert MTB/RIF® test result is unavailable, a repeat Xpert MTB/RIF® assay should be performed by the study laboratory to confirm eligibility before recruitment. 3. The patient should be aged ≥ 18 years on the day of providing informed consent. 4. The patient has a body weight in light clothing and without shoes of at least 35kg. 5. Female patients of child-bearing potential must have a negative urine or serum pregnancy test ≤ 7 days prior to screening, and consent to practice an effective method of contraception until completion of therapy. 6. The patient must have a verifiable residence location and telephone number that is accessible if necessary for contact during follow-up. Exclusion Criteria: * Patients for whom one of the following criteria is met will be excluded from the trial: 1. There is concern about any circumstances that raise concern about free, informed consent to study participation. 2. The patient's pre-screening or screening Xpert MTB/RIF® assay result is "negative","trace", or "very low" positive. 3. At least one M tuberculosis isolate, either cultured or detected through molecular assays from sputum obtained from the patient prior to treatment initiation is found to be resistant to one or more of: rifampicin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones (late exclusion). 4. The patient is in poor general condition where delay in treatment cannot be tolerated, or death within three months is likely, as assessed by the investigator. 5. The patient had a nose/throat swab which was positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2), on Polymerase Chain Reaction (PCR) or a rapid diagnostic test ≤ 14 days preceding study recruitment. 6. The patient is pregnant or breast-feeding (female patients only). 7. The patient is unable to take oral medications. 8. The patient has received any investigational drug in the past three months. 9. The patient has received more than five days of treatment directed against active tuberculosis ≤ 6 months preceding initiation of study drugs. 10. The patient has known intolerance to any of the study drugs, or conditions for which they are contra-indicated. 11. The patient is unwilling, or unable to adhere to requirements regarding restricted use of other medications during the study. Restricted medications will include medications which prolong the QTc interval, and CYP450 inhibitors or inducers. 12. The patient is due to initiate, or requires continuation of, non-efavirenz, non-dolutegravir-based anti-retroviral therapy for HIV infection. 13. The patient has decompensated liver disease and/or aminotransaminases \>3x upper limit of normal (ULN), serum total bilirubin level \>1.5x ULN or serum/plasma creatinine level \>x2 ULN. 14. The patient has a baseline QTc interval of \>450ms. 15. The patient is being, or about to be, treated for malaria. 16. The patient has other medical conditions that, in the investigator's judgement, make study participation not in the individual's best interest.
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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
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Kibong'oto Infectious Diseases Hospital
Moshi, Kilimanjaro, 25401, Tanzania
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Other studies related to the condition(s) this trial covers.
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