Tuberculosis, PulmonaryPhase 2/3TRUNCATE-TBNCT03474198
Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis
A Phase 2/3 study testing Rifampicin, Isoniazid and Pyrazinamide in people with Tuberculosis, Pulmonary, run by University College, London at 18 sites in 6 countries.
Trial summary
The current standard management strategy for drug-sensitive pulmonary tuberculosis (TB) is to treat with multiple drugs for 6 months, although patients often fail to adhere to the long treatment, leading to poor clinical outcomes including drug resistance, which is expensive and difficult to treat. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Rifampicin, Isoniazid and Pyrazinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 21 Mar 2018to 20 Jan 2022
- Phase
- Phase 2/3
- 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
- Age 18 to 65 years
- Clinical symptoms consistent with pulmonary TB and/or evidence of pulmonary TB on chest X-ray (CXR)
- Sputum GeneXpert test positive
- Willing to comply with the study visits and procedures
- Resident at a fixed address
- Willing to have directly observed therapy
- Willing and able to provide written informed consent
Who cannot join
- Taken more than 10 daily doses of standard anti-TB medication or fluoroquinolones during the 3 months prior to randomisation
- Previous active TB disease for which treatment was given prior to the current episode
- Known or suspected extra-pulmonary TB
- Severe clinical pulmonary TB
- Sputum smear 3+ on microscopy*
- Cavity size > 4cm on screening CXR*
Show all 33Show fewer
- Presence of rifampicin resistance on GeneXpert test
- Poorly-controlled diabetes that, in the opinion of the investigator, is unlikely to be controlled with available management strategies
- Active malignancy requiring systemic chemotherapy or radiotherapy
- Known Hepatitis B surface antigen positive and/or HCV antibody positive, unless liver function tests consistently within normal range for at least 2 years
- History of myocardial infarction, congestive cardiac failure, cardiac arrhythmias or any known congenital cardiac problems
- History of severe chronic lung disease with symptom score of ≥3 on MRC breathlessness scale
- History of seizures
- Current tendinitis or history of tendinopathy associated with fluoroquinolone use
- Symptomatic peripheral neuropathy causing greater than minimal interference with usual social and functional activities
- Current alcohol or drug abuse
- Women who are currently pregnant or breast-feeding
- Women of childbearing potential unwilling or unable to use appropriate effective contraception for the first 6 months of the trial
- Known allergy to one or more of the study drugs
- Taking a concomitant medication that has a known or predicted interaction with any of the study drugs to which the patient might be randomised, or is known to prolong the QTc interval
- Taking any immunosuppressive drugs or use of systemic corticosteroids for more than 2 weeks prior to screening
- Colour blindness detected by Ishihara test
- 23.12-lead ECG at screening shows QTc greater than 450ms and/or any other clinically-significant abnormality such as arrhythmia or ischaemia
- 24.Any of the following laboratory parameters at screening:
- Absolute neutrophil <1000 cells/mL, haemoglobin <7.0 g/dL, OR platelet count <50,000 cells/mm3
- Creatinine clearance of <60ml/min (calculated using Cockcroft-Gault equation)
- ALT greater than 3 times the upper limit of normal
- Uncorrected serum potassium <3.5 mmol/L
- 25.HIV antibody positive at screening
- 26.Any other significant condition (e.g. psychiatric illness, chronic diarrhoeal disease), that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial or lead to poor compliance with study visits and protocol requirements
- 27.Participation in other clinical intervention trial or research protocol
- Note: Criteria may be modified in later stages of the trial
- -
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Philippines6 sites
Perpetual Succour Hospital
Cebu
De La Salle Health Sciences Institute
Manila
Lung Center Philippines
Manila
Philippines Tuberculosis Society Incorporated (PTSI)
Manila
Tropical Disease Foundation
Manila
Quezon Institute
Quezon City
Indonesia5 sites
Universitas Padjadjaran
Bandung
Persahbahatan Hospital
Jakarta
Wahidin Sudirohusodo Hospital
Makassar
Saiful Anwar Hospital
Malang
Soetomo General Hospital
Surabaya
Uganda3 sites
Infectious Diseases Institute
Kampala
Joint Clinical Research Centre
Kampala
Joint Clinical Research Centre
Mbarara
Thailand2 sites
King Chulalongkorn Memorial Hospital
Bangkok
Central Chest Institute of Thailand
Nonthaburi
About this study
The current standard management strategy for drug-sensitive pulmonary tuberculosis (TB) is to treat with multiple drugs for 6 months, although patients often fail to adhere to the long treatment, leading to poor clinical outcomes including drug resistance, which is expensive and difficult to treat.
The TRUNCATE-TB trial evaluates an alternative strategy (the TRUNCATE-TB Management Strategy) comprising treatment for 2 months (8 weeks, extended to 12 weeks if inadequate clinical response) with a regimen predicted to have enhanced sterilising activity ("boosted regimen") and monitoring closely after treatment cessation. Those who relapse (predicted to be always drug sensitive and likely to occur early) will be retreated with a standard 6 month regimen.
Read more
The trial is a randomized, open-label, multi-arm, multi-stage (MAMS) trial to test the hypothesis that the TRUNCATE-TB Management Strategy is non-inferior to the standard management strategy in terms of longer-term outcomes (clinical status at 96 weeks). If non-inferiority is demonstrated then the advantages/disadvantages of implementing the strategy will be explored in secondary outcomes (from patient and programme perspective).
The trial will evaluate the TRUNCATE-TB Management Strategy with 4 potential boosted regimens (180 per arm, total 900 with the standard TB management strategy arm). The boosted regimens include new drugs (licensed drugs, repurposed from other indications) and optimized doses of standard drugs, selected based on consideration of maximal sterilising effect, absence of drug-drug interactions, as well as safety and tolerability over a period of 2 months
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Rifampicin, Isoniazid, Pyrazinamide, Ethambutol, Linezolid
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampicinDrug
10mg/kg
IsoniazidDrug
5mg/kg
PyrazinamideDrug
25mg/kg
EthambutolDrug
15mg/kg
LinezolidDrug
600mg
ClofazimineDrug
200mg
RifapentineDrug
1200mg
LevofloxacinDrug
1000mg
BedaquilineDrug
400mg once daily for 2 weeks then 200mg 3x a week
RifampicinDrug
35mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Standard TB Management Strategy | Active comparator | Standard combination treatment for pulmonary TB of 8 weeks rifampicin, isoniazid, pyrazinamide, ethambutol, then 16 weeks rifampicin, isoniazid only Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol |
| TRUNCATE-TB Management Strategy using Regimen B | Experimental | TRUNCATE-TB Management Strategy: 8 weeks* of initial treatment using Regimen B; close monitoring after treatment completion; treatment of relapse with 24 weeks of standard treatment.
*If persistent symptoms and positive smear at week 8, extend to 12 weeks of treatment using Regimen B; if persistent symptoms and positive smear at week 12, switch to standard treatment regimen and extend to 24 weeks of treatment.
Regimen B: Rifampicin (35mg/kg), isoniazid, pyrazinamide, ethambutol, linezolid Receives: Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol; Drug: Linezolid; Drug: Rifampicin |
| TRUNCATE-TB Management Strategy using Regimen C | Experimental | TRUNCATE-TB Management Strategy as described above, using Regimen C in place of B.
Regimen C: Rifampicin (35mg/kg), isoniazid, pyrazinamide, ethambutol, clofazimine Receives: Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol; Drug: Clofazimine; Drug: Rifampicin |
| TRUNCATE-TB Management Strategy using Regimen D | Experimental | TRUNCATE-TB Management Strategy as described above, using Regimen D in place of B.
Regimen D: Rifapentine, isoniazid, pyrazinamide, linezolid, levofloxacin Receives: Drug: Isoniazid; Drug: Pyrazinamide; Drug: Linezolid; Drug: Rifapentine; Drug: Levofloxacin |
| TRUNCATE-TB Management Strategy using Regimen E | Experimental | TRUNCATE-TB Management Strategy as described above, using Regimen E in place of B.
Regimen E: Isoniazid, pyrazinamide, ethambutol, linezolid, bedaquiline Receives: Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol; Drug: Linezolid; Drug: Bedaquiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsatisfactory clinical outcome at week 96 after randomisation
As defined by ongoing requirement for TB treatment at week 96 OR ongoing TB disease activity at week 96 (clinical, microbiological and/or imaging evidence) OR death before week 96
Measured: 96 weeks
Secondary outcomes (12)
Acceptability of the strategy using trial-specific questionnaire
7-item trial-specific questionnaire
Measured: 96 weeks
Total days on TB drug treatment
Measured: 96 weeks
Time off work or study due to illness/treatment
Measured: 96 weeks
Total Quality of life using MOS-HIV questionnaire
MOS-HIV questionnaire
Measured: 96 weeks
Respiratory disability at week 96
Measured: 96 weeks
Total Grade 3 or 4 clinical adverse events
Measured: 96 weeks
Total serious adverse events
Measured: 96 weeks
Death
Measured: 96 weeks
Adherence to TB medication
Measured: Either during first 8 weeks or at any time during period when TB treatment is prescribed
Treatment default
Measured: Either during first 8 weeks or at any time during period when TB treatment is prescribed
Acquired drug resistance by week 96
Measured: 96 weeks
Community transmission risk
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start21 Mar 2018
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a multi-arm, multi-stage (MAMS) parallel study design
- Masking
- None (open label)
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore, Singapore Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Nicholas Paton, Study director, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474198
- Sponsor's protocol ID
- TRUNCATE-TB
- Acronym
- TRUNCATE-TB
- Status last verified
- Aug 2023
- First submitted
- 12 Mar 2018
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paton NI, Cousins C, Sari IP, Burhan E, Ng NK, Dalay VB, Suresh C, Kusmiati T, Chew KL, Balanag VM, Lu Q, Ruslami R, Djaharuddin I, Sugiri JJR, Veto RS, Sekaggya-Wiltshire C, Avihingsanon A, Saini JK, Papineni P, Nunn AJ, Crook AM; TRUNCATE-TB Trial Team. Efficacy and safety of 8-week regimens for the treatment of rifampicin-susceptible pulmonary tuberculosis (TRUNCATE-TB): a prespecified exploratory analysis of a multi-arm, multi-stage, open-label, randomised controlled trial. Lancet Infect Dis. 2025 Oct;25(10):1084-1096. doi: 10.1016/S1473-3099(25)00151-3. Epub 2025 May 22.
PubMed 40414233Paton NI, Cousins C, Suresh C, Burhan E, Chew KL, Dalay VB, Lu Q, Kusmiati T, Balanag VM, Lee SL, Ruslami R, Pokharkar Y, Djaharuddin I, Sugiri JJR, Veto RS, Sekaggya-Wiltshire C, Avihingsanon A, Sarin R, Papineni P, Nunn AJ, Crook AM; TRUNCATE-TB Trial Team. Treatment Strategy for Rifampin-Susceptible Tuberculosis. N Engl J Med. 2023 Mar 9;388(10):873-887. doi: 10.1056/NEJMoa2212537. Epub 2023 Feb 20.
PubMed 36808186Converse PJ, Almeida DV, Tasneen R, Saini V, Tyagi S, Ammerman NC, Li SY, Anders NM, Rudek MA, Grosset JH, Nuermberger EL. Shorter-course treatment for Mycobacterium ulcerans disease with high-dose rifamycins and clofazimine in a mouse model of Buruli ulcer. PLoS Negl Trop Dis. 2018 Aug 13;12(8):e0006728. doi: 10.1371/journal.pntd.0006728. eCollection 2018 Aug.
PubMed 30102705
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis
- ClinicalTrials.gov ID
- NCT03474198
- Acronym / sponsor ID
- TRUNCATE-TB / TRUNCATE-TB
- Conditions
- Tuberculosis, Pulmonary
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, Singapore Clinical Research Institute
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current standard management strategy for drug-sensitive pulmonary tuberculosis (TB) is to treat with multiple drugs for 6 months, although patients often fail to adhere to the long treatment, leading to poor clinical outcomes including drug resistance, which is expensive and difficult to treat.
The TRUNCATE-TB trial evaluates an alternative strategy (the TRUNCATE-TB Management Strategy) comprising treatment for 2 months (8 weeks, extended to 12 weeks if inadequate clinical response) with a regimen predicted to have enhanced sterilising activity ("boosted regimen") and monitoring closely after treatment cessation. Those who relapse (predicted to be always drug sensitive and likely to occur early) will be retreated with a standard 6 month regimen.
The trial is a randomized, open-label, multi-arm, multi-stage (MAMS) trial to test the hypothesis that the TRUNCATE-TB Management Strategy is non-inferior to the standard management strategy in terms of longer-term outcomes (clinical status at 96 weeks). If non-inferiority is demonstrated then the advantages/disadvantages of implementing the strategy will be explored in secondary outcomes (from patient and programme perspective).
The trial will evaluate the TRUNCATE-TB Management Strategy with 4 potential boosted regimens (180 per arm, total 900 with the standard TB management strategy arm). The boosted regimens include new drugs (licensed drugs, repurposed from other indications) and optimized doses of standard drugs, selected based on consideration of maximal sterilising effect, absence of drug-drug interactions, as well as safety and tolerability over a period of 2 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This study uses a multi-arm, multi-stage (MAMS) parallel study design
| Arm | Type | Receives |
|---|---|---|
| Standard TB Management Strategy | Active comparator | Drug: Rifampicin, Drug: Isoniazid, Drug: Pyrazinamide, Drug: EthambutolStandard combination treatment for pulmonary TB of 8 weeks rifampicin, isoniazid, pyrazinamide, ethambutol, then 16 weeks rifampicin, isoniazid only |
| TRUNCATE-TB Management Strategy using Regimen B | Experimental | Drug: Isoniazid, Drug: Pyrazinamide, Drug: Ethambutol, Drug: Linezolid, Drug: RifampicinTRUNCATE-TB Management Strategy: 8 weeks* of initial treatment using Regimen B; close monitoring after treatment completion; treatment of relapse with 24 weeks of standard treatment. *If persistent symptoms and positive smear at week 8, extend to 12 weeks of treatment using Regimen B; if persistent symptoms and positive smear at week 12, switch to standard treatment regimen and extend to 24 weeks of treatment. Regimen B: Rifampicin (35mg/kg), isoniazid, pyrazinamide, ethambutol, linezolid |
| TRUNCATE-TB Management Strategy using Regimen C | Experimental | Drug: Isoniazid, Drug: Pyrazinamide, Drug: Ethambutol, Drug: Clofazimine, Drug: RifampicinTRUNCATE-TB Management Strategy as described above, using Regimen C in place of B. Regimen C: Rifampicin (35mg/kg), isoniazid, pyrazinamide, ethambutol, clofazimine |
| TRUNCATE-TB Management Strategy using Regimen D | Experimental | Drug: Isoniazid, Drug: Pyrazinamide, Drug: Linezolid, Drug: Rifapentine, Drug: LevofloxacinTRUNCATE-TB Management Strategy as described above, using Regimen D in place of B. Regimen D: Rifapentine, isoniazid, pyrazinamide, linezolid, levofloxacin |
| TRUNCATE-TB Management Strategy using Regimen E | Experimental | Drug: Isoniazid, Drug: Pyrazinamide, Drug: Ethambutol, Drug: Linezolid, Drug: BedaquilineTRUNCATE-TB Management Strategy as described above, using Regimen E in place of B. Regimen E: Isoniazid, pyrazinamide, ethambutol, linezolid, bedaquiline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 65 years
- Clinical symptoms consistent with pulmonary TB and/or evidence of pulmonary TB on chest X-ray (CXR)
- Sputum GeneXpert test positive
- Willing to comply with the study visits and procedures
- Resident at a fixed address
Key exclusion criteria (33 listed)
- Taken more than 10 daily doses of standard anti-TB medication or fluoroquinolones during the 3 months prior to randomisation
- Previous active TB disease for which treatment was given prior to the current episode
- Known or suspected extra-pulmonary TB
- Severe clinical pulmonary TB
- Sputum smear 3+ on microscopy*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifampicin10mg/kg | Drug | Standard TB Management Strategy |
| Isoniazid5mg/kg | Drug | Standard TB Management Strategy, TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen C, TRUNCATE-TB Management Strategy using Regimen D, TRUNCATE-TB Management Strategy using Regimen E |
| Pyrazinamide25mg/kg | Drug | Standard TB Management Strategy, TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen C, TRUNCATE-TB Management Strategy using Regimen D, TRUNCATE-TB Management Strategy using Regimen E |
| Ethambutol15mg/kg | Drug | Standard TB Management Strategy, TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen C, TRUNCATE-TB Management Strategy using Regimen E |
| Linezolid600mg | Drug | TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen D, TRUNCATE-TB Management Strategy using Regimen E |
| Clofazimine200mg | Drug | TRUNCATE-TB Management Strategy using Regimen C |
| Rifapentine1200mg | Drug | TRUNCATE-TB Management Strategy using Regimen D |
| Levofloxacin1000mg | Drug | TRUNCATE-TB Management Strategy using Regimen D |
| Bedaquiline400mg once daily for 2 weeks then 200mg 3x a week | Drug | TRUNCATE-TB Management Strategy using Regimen E |
| Rifampicin35mg/kg | Drug | TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen C |
Primary outcome
Unsatisfactory clinical outcome at week 96 after randomisation
Time frame: 96 weeks
As defined by ongoing requirement for TB treatment at week 96 OR ongoing TB disease activity at week 96 (clinical, microbiological and/or imaging evidence) OR death before week 96
12 secondary outcomes
Acceptability of the strategy using trial-specific questionnaire
Time frame: 96 weeks
Total days on TB drug treatment
Time frame: 96 weeks
Time off work or study due to illness/treatment
Time frame: 96 weeks
Total Quality of life using MOS-HIV questionnaire
Time frame: 96 weeks
Respiratory disability at week 96
Time frame: 96 weeks
Total Grade 3 or 4 clinical adverse events
Time frame: 96 weeks
Total serious adverse events
Time frame: 96 weeks
Death
Time frame: 96 weeks
Adherence to TB medication
Time frame: Either during first 8 weeks or at any time during period when TB treatment is prescribed
Treatment default
Time frame: Either during first 8 weeks or at any time during period when TB treatment is prescribed
Acquired drug resistance by week 96
Time frame: 96 weeks
Community transmission risk
Time frame: 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 40414233Paton NI, Cousins C, Sari IP, Burhan E, Ng NK, Dalay VB, Suresh C, Kusmiati T, Chew KL, Balanag VM, Lu Q, Ruslami R, Djaharuddin I, Sugiri JJR, Veto RS, Sekaggya-Wiltshire C, Avihingsanon A, Saini JK, Papineni P, Nunn AJ, Crook AM; TRUNCATE-TB Trial Team. Efficacy and safety of 8-week regimens for the treatment of rifampicin-susceptible pulmonary tuberculosis (TRUNCATE-TB): a prespecified exploratory analysis of a multi-arm, multi-stage, open-label, randomised controlled trial. Lancet Infect Dis. 2025 Oct;25(10):1084-1096. doi: 10.1016/S1473-3099(25)00151-3. Epub 2025 May 22.
- Derived from this study: PubMed 36808186Paton NI, Cousins C, Suresh C, Burhan E, Chew KL, Dalay VB, Lu Q, Kusmiati T, Balanag VM, Lee SL, Ruslami R, Pokharkar Y, Djaharuddin I, Sugiri JJR, Veto RS, Sekaggya-Wiltshire C, Avihingsanon A, Sarin R, Papineni P, Nunn AJ, Crook AM; TRUNCATE-TB Trial Team. Treatment Strategy for Rifampin-Susceptible Tuberculosis. N Engl J Med. 2023 Mar 9;388(10):873-887. doi: 10.1056/NEJMoa2212537. Epub 2023 Feb 20.
- Derived from this study: PubMed 30102705Converse PJ, Almeida DV, Tasneen R, Saini V, Tyagi S, Ammerman NC, Li SY, Anders NM, Rudek MA, Grosset JH, Nuermberger EL. Shorter-course treatment for Mycobacterium ulcerans disease with high-dose rifamycins and clofazimine in a mouse model of Buruli ulcer. PLoS Negl Trop Dis. 2018 Aug 13;12(8):e0006728. doi: 10.1371/journal.pntd.0006728. eCollection 2018 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Paton study director
National University Hospital, Singapore
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rifampicin, Isoniazid and Pyrazinamide in people with Tuberculosis, Pulmonary, run by University College, London at 18 sites in 6 countries.
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 7 inclusion and 33 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Philippines, Indonesia, Uganda, Thailand, India and 1 more country. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Unsatisfactory clinical outcome at week 96 after randomisation (time frame: 96 weeks). 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 NCT03474198, which also lists 3 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 14 Aug 2023.