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TuberculosisPhase 3OptiRiMoxTBNCT05575518

A Pragmatic Trial With Optimized Dose of Rifampicin and Moxifloxacin for the Treatment of Drug Susceptible Pulmonary Tuberculosis

A Phase 3 study testing Optimised rifamycin in people with Tuberculosis and Human Immunodeficiency Virus, run by Stellah Mpagama at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Tuberculosis (TB) remains a major global public health problem, particularly in low- and middle-income countries (LMICs) in Africa, Asia, and Eastern Europe. Approximately 10 million people fall sick with TB, causing up to 2 million deaths, worldwide per year. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tuberculosis, Human Immunodeficiency Virus
What is being tested?
Optimised rifamycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
1 siteTanzania
Study dates
11 Aug 2023to 30 Sep 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each patient must meet all the following inclusion criteria prior to enrolment into the trial:
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
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  • The patient should be aged ≥ 18 years on the day of providing informed consent.
  • The patient has a body weight in light clothing and without shoes of at least 35kg.
  • 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.
  • The patient must have a verifiable residence location and telephone number that is accessible if necessary for contact during follow-up.

Who cannot join

  • Patients for whom one of the following criteria is met will be excluded from the trial:
  • There is concern about any circumstances that raise concern about free, informed consent to study participation.
  • The patient's pre-screening or screening Xpert MTB/RIF® assay result is "negative","trace", or "very low" positive.
  • 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).
  • 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.
  • 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.
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  • The patient is pregnant or breast-feeding (female patients only).
  • The patient is unable to take oral medications.
  • The patient has received any investigational drug in the past three months.
  • The patient has received more than five days of treatment directed against active tuberculosis ≤ 6 months preceding initiation of study drugs.
  • The patient has known intolerance to any of the study drugs, or conditions for which they are contra-indicated.
  • 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.
  • The patient is due to initiate, or requires continuation of, non-efavirenz, non-dolutegravir-based anti-retroviral therapy for HIV infection.
  • 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.
  • The patient has a baseline QTc interval of >450ms.
  • The patient is being, or about to be, treated for malaria.
  • The patient has other medical conditions that, in the investigator's judgement, make study participation not in the individual's best interest.

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Kibong'oto Infectious Diseases Hospital

    Moshi, Kilimanjaro, 25401

Other trials in Tanzania

About this study

Tuberculosis (TB) remains a major global public health problem, particularly in low- and middle-income countries (LMICs) in Africa, Asia, and Eastern Europe. Approximately 10 million people fall sick with TB, causing up to 2 million deaths, worldwide per year. Considerable progress was made in TB control from 1990-2015, motivating the World Health Organization (WHO) to launch an ambitious EndTB strategy. However, the effect of the ongoing Coronavirus Disease 2019 (Covid-19) pandemic has been devastating and the last two years have seen the first year-on-year increases (of 5.6%) in TB mortality since 2005 . In order to regain lost ground, and re-establish progress towards elimination of TB, innovation is needed in all aspects of TB control, including development of shorter treatment regimens for drug susceptible (DS) and multi-drug resistant / rifampicin resistant (MDR/RR) forms of the disease.

This protocol seeks to conduct the TB clinical trial combining the 8-methoxyfluroquinolone and optimised dose of rifamycing to address two questions. The first is to confirm the non-inferiority of a four-month optimised dose rifamycin and moxifloxacin-based regimen amongst African TB patient populations with high rates of co-incident HIV. Secondly, we seek to establish that the rifamycin of choice in potent 4-month anti-TB treatments could be rifampicin as this will be more rapidly up-scalable for public health impact.

Read the detailed description

The study objectives of this clinical trial are

Primary effectiveness objective: To evaluate whether one or both of two experimental regimens based on optimised dose rifampicin with or without moxifloxacin and given for 16 weeks are non-inferior to standard treatment for drug-susceptible tuberculosis given for 26 weeks, as assessed by patient survival, free of tuberculosis 12 months after initiation of therapy.

Primary safety objective: To evaluate whether one or both of two experimental regimens based on optimised dose rifampicin with or without moxifloxacin and given for 16 weeks are as safe and tolerable as standard treatment for drug-susceptible tuberculosis given for 26 weeks, as assessed by the frequency of Adverse Events (AEs) of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 severity or higher.

Participants will be individuals with bacteriological confirmed pulmonary TB aged 18 years or above, with or without HIV co-infection in Gabon, Malawi, Mozambique and Tanzania. The trial sites are also established members of the PanACEA / SimpliciTB group including the Centre de Recherches Médicales de Lambaréné (CERMEL)-Gabon, the Helse Nord Tuberculosis Initiative (HNTI) at Kamuzu University of Health Sciences (KUHES)-Malawi and the Polana Caniço Health Research and Training Center (CISPOC) at the Instituto Nacional de Saúde (INS)-Mozambique and the Kibong'oto Infectious Diseases Hospital-Tanzania.

Being tested
Optimised rifamycin
Keywords
TB/HIV, Phase III, Randomised
Medical subject headings
Tuberculosis, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimised rifamycinDrug

    Also called 8-methoxy-fluoroquinolone

    optimised dose rifampicin with or without moxifloxacin

Study groups in NCT05575518
Study groupRoleWhat they receive
No interventionNo interventionStandard of care according to the National TB Programmes which is a weight-banded rifampicin, isoniazid, pyrazinamide, and ethambutol for weeks 0-8 followed by rifampicin and isoniazid for weeks 9-26.
Experimental Arm 1ExperimentalOptimised dose of rifampicin. The rifampicin 35mg/kg alongside standard weight-banded doses of isoniazid, pyrazinamide, and ethambutol, once daily
Receives: Drug: Optimised rifamycin
Experimental Arm 2ExperimentalOptimised dose of rifampicin and moxifloxacin. The rifampicin 35mg/kg and moxifloxacin 400mg alongside standard weight-banded doses of isoniazid and pyrazinamide, once daily.
Receives: Drug: Optimised rifamycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bacteriological cure, absence of either TB treatment failure or relapse

    Treatment failure, defined as submitting two sputum samples with positive culture for M tuberculosis on different visits, when the first of these samples was collected at or after two weeks prior to the scheduled end of treatment.

    TB relapse, defined as submitting two sputum samples with positive culture for M tuberculosis on different visits, when the first of these samples was collected after completion of scheduled TB therapy and where at least one of the M tuberculosis isolates is genetically similar to the baseline strain.

    Measured: Participant survival, free of tuberculosis 12 months after randomisation

  2. Proportional of adverse events (AE) of grade 3 severity or higher

    The severity of all AEs will be classified according to the U.S. National Institutes of Health Common Terminology Criteria for Adverse Events 5.0 (CTCAE).

    Measured: 4 or 6 months of treatment

Secondary outcomes (4)

  1. Proportional of clinically significant adverse events related to the intervention

    Treatment discontinuation or interruption related to AE

    Measured: 4 or 6 months of treatment

  2. Clinical improvement of TB symptoms

    Clinical response of TB symptoms as measured by questionnaire

    Measured: 12 month after randomisation

  3. Clinical improvement of body mass index (BMI)

    Increase of BMI as measured by the ratio of weight (kg) and height squared in metres squared

    Measured: 12 month after randomisation

  4. Clinical improvement of participant reported health status

    Increase of participant reported health status as measured by questionnaire

    Measured: 12 month after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2022
  2. Study start11 Aug 2023
  3. Primary completion25 May 2026
  4. Study completion30 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05575518
Sponsor's protocol ID
OptiRiMoxTB-01
Acronym
OptiRiMoxTB
Status last verified
Sep 2026
First submitted
6 Oct 2022
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • World Health Organization. Global Tuberculosis Report 2021. World Health Organisation 2021.https://www.who.int/publications/i/item/9789240037021

  • World Health Organisation. WHO End TB Strategy: Global strategy and targets for tuberculosis prevention, care and control after 2015. World Health Organization 2021. https://www.who.int/tb/strategy/End_TB_Strategy.pdf

  • Pai M, Kasaeva T, Swaminathan S. Covid-19's Devastating Effect on Tuberculosis Care - A Path to Recovery. N Engl J Med. 2022 Apr 21;386(16):1490-1493. doi: 10.1056/NEJMp2118145. Epub 2022 Jan 5. No abstract available.

    PubMed 34986295

  • Boeree MJ, Diacon AH, Dawson R, Narunsky K, du Bois J, Venter A, Phillips PP, Gillespie SH, McHugh TD, Hoelscher M, Heinrich N, Rehal S, van Soolingen D, van Ingen J, Magis-Escurra C, Burger D, Plemper van Balen G, Aarnoutse RE; PanACEA Consortium. A dose-ranging trial to optimize the dose of rifampin in the treatment of tuberculosis. Am J Respir Crit Care Med. 2015 May 1;191(9):1058-65. doi: 10.1164/rccm.201407-1264OC.

    PubMed 25654354

  • Te Brake LHM, de Jager V, Narunsky K, Vanker N, Svensson EM, Phillips PPJ, Gillespie SH, Heinrich N, Hoelscher M, Dawson R, Diacon AH, Aarnoutse RE, Boeree MJ; PanACEA Consortium. Increased bactericidal activity but dose-limiting intolerability at 50 mg.kg-1 rifampicin. Eur Respir J. 2021 Jul 8;58(1):2000955. doi: 10.1183/13993003.00955-2020. Print 2021 Jul.

    PubMed 33542056

  • Boeree MJ, Heinrich N, Aarnoutse R, Diacon AH, Dawson R, Rehal S, Kibiki GS, Churchyard G, Sanne I, Ntinginya NE, Minja LT, Hunt RD, Charalambous S, Hanekom M, Semvua HH, Mpagama SG, Manyama C, Mtafya B, Reither K, Wallis RS, Venter A, Narunsky K, Mekota A, Henne S, Colbers A, van Balen GP, Gillespie SH, Phillips PPJ, Hoelscher M; PanACEA consortium. High-dose rifampicin, moxifloxacin, and SQ109 for treating tuberculosis: a multi-arm, multi-stage randomised controlled trial. Lancet Infect Dis. 2017 Jan;17(1):39-49. doi: 10.1016/S1473-3099(16)30274-2. Epub 2016 Oct 26.

    PubMed 28100438

  • Dorman SE, Nahid P, Kurbatova EV, Phillips PPJ, Bryant K, Dooley KE, Engle M, Goldberg SV, Phan HTT, Hakim J, Johnson JL, Lourens M, Martinson NA, Muzanyi G, Narunsky K, Nerette S, Nguyen NV, Pham TH, Pierre S, Purfield AE, Samaneka W, Savic RM, Sanne I, Scott NA, Shenje J, Sizemore E, Vernon A, Waja Z, Weiner M, Swindells S, Chaisson RE; AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. N Engl J Med. 2021 May 6;384(18):1705-1718. doi: 10.1056/NEJMoa2033400.

    PubMed 33951360

  • World Health Organization. WHO consolidated guidelines on tuberculosis Module 4: Drug-susceptible tuberculosis treatment. World Health Organization 2022 https://www.who.int/publications/i/item/9789240048126

  • Mlyuka HJ, Liyoyo A, Nyaulingo B, Mpolya E, Kaswaga OL, Semvua H, Lwambura S, McHugh TD, Wildner L, Sabiiti W, Adegbite BR, Nliwasa M, Khosa C, Mbelele P, Mbeya B, Jeremiah K, Boeree MJ, Gillespie SH, Sloan DJ, Mpagama SG; SimpliciTB Consortium. A pragmatic trial with an optimized dose of rifampicin and moxifloxacin for the treatment of drug-susceptible pulmonary tuberculosis: a study protocol for open-label, randomized phase III trial (OptiRiMoxTB). Trials. 2026 Jan 30;27(1):182. doi: 10.1186/s13063-026-09466-0.

    PubMed 41612490

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Optimised rifamycin in people with Tuberculosis and Human Immunodeficiency Virus, run by Stellah Mpagama at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacteriological cure, absence of either TB treatment failure or relapse (time frame: Participant survival, free of tuberculosis 12 months after randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05575518, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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