TuberculosisPhase 3SMILE-TBNCT06253715
Shortened Regimen for Drug-susceptible TB in Children
A Phase 3 study testing Isoniazid, Rifampin and Pyrazinamide in people with Tuberculosis and Tuberculosis, Pulmonary, run by Johns Hopkins University at 9 sites in 7 countries.
Trial summary
While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Read more about this study
- Who is it for?
- Ages 0 days to 9 years
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Lymph Node
- What is being tested?
- Isoniazid, Rifampin and Pyrazinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 15 Jan 2025to 30 Sep 2027
- Phase
- Phase 3
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 0 days to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee/Institutional Review Board (EC/IRB) policies and procedures, potential participant is willing and able to provide assent for study participation.
- At Entry, age of less than 10 years.
- At Entry, weight 3 kilograms (kg) or greater.
- At Entry, diagnosed with TB disease, defined as:
- Pulmonary (including pleural effusion) and/or lymph node (extra-thoracic and/or intra-thoracic) TB with or without bacteriologic confirmation;
- Clinician has decided to treat with standard first-line drug-susceptible TB regimen.
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- Known HIV status or HIV testing in progress based on meeting testing requirements.
- Has normal, Grade 1 or 2 test results for all of the following done at or within 14 days of Entry (including the most recent):
- Alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal;
- Total bilirubin less than or equal to 2.5 times the upper limit of normal;
- Potassium level of 3.0 milliequivalent/L or greater;
- Hemoglobin level of 7.0 g/dL or greater;
- Platelet count of 100,000/mm3 or greater;
- Estimated glomerular filtration rate (eGFR; bedside Schwartz formula) 60 mL/min/1.73m2 or higher.
- For children living with HIV:
- On antiretroviral therapy (ART) at Entry: Must be on, or able to be switched to a dolutegravir-based regimen at or prior to Entry;
- Not on ART at Entry: Planned initiation of dolutegravir before or at study Week 4.
- For participants who have reached menarche or who are engaging in sexual activity (self-reported): negative serum or urine pregnancy test within 7 days of Entry.
- For participants who are engaging in sexual activity that could lead to pregnancy (self-reported): agrees to practice at least one non-hormonal method of contraception or abstain from heterosexual intercourse during study drug treatment and for 30 days after stopping study medications. Non-hormonal methods include:
- Male or female condoms
- Diaphragm or cervical cap (with spermicide, if available)
- Non-hormonal intrauterine device (IUD) or intrauterine system (IUS)
- At Entry, intends to remain in the catchment area of the study site for the duration of study follow-up or willingness to be followed up beyond the catchment area if/when applicable, as determined by the site investigator based on participant/parent/guardian report.
Who cannot join
- Presumed or documented extra-pulmonary TB involving the central nervous system and/or bones and/or joints, and/or miliary TB, and/or pericardial TB and/or TB of the gastrointestinal (GI) tract and/or renal TB.
- Premature infant (born less than 37-weeks gestation) who is less than 3 months of age at Entry.
- Any known contraindication to taking any study drug:
- Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs;
- Any prohibited medications within three days prior to Entry or planned use within the following 6 months;
- Unable to take oral medications;
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- Known history of prolonged QT syndrome not caused by electrolyte derangements.
- Received more than 10 days of treatment directed against TB disease within 6 months preceding initiation of study drugs.
- M. tuberculosis isolate known or suspected to be resistant to isoniazid, rifampin, pyrazinamide, ethambutol, and/or fluoroquinolones.
- Known exposure to an infectious adult with drug-resistant TB, including resistance to isoniazid, rifampin, pyrazinamide, ethambutol, and/or fluoroquinolones.
- Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- Previously enrolled in this study.
- Late Exclusions:
- M. tuberculosis cultured or detected through World Health Organization (WHO) approved molecular assays (e.g., Cepheid Xpert MTB/RIF, Xpert XDR, sequencing or Hain MTB-DR plus assays) from sputum, swallowed sputum, nasopharyngeal aspirates, stool, or lymph node aspirate obtained around the time of study entry is determined to be resistant to isoniazid and/or rifampin and/or pyrazinamide and/or ethambutol and/or fluoroquinolones.
- Any child with a clinical TB diagnosis who is found to have a definitive alternative diagnosis for their presenting signs and symptoms whose TB treatment is discontinued prior to completion.
Trial locations and contacts
9 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 7 countries
India2 sites, 2 recruiting
- Recruiting
Indian Council of Medical Research - National Institute for Research in Tuberculosis
Chennai
Aishwarya Venkataraman, MBBS, DCH, PgDip PID, MRCPCH, +44 2836 9500 ext. 9533, venkataraman.a@icmr.gov.in
Aishwarya Venkataraman, MBBS, DCH, PgDip PID, MRCPCH
- Recruiting
Dr. D.Y. Patil Medical College, Hospital and Research Center
Pune
Shailaja Mane, MBBS, MD, PGDAP, FRIPH, +91 9822595553, shailaja.mane@dpu.edu.in
Shailaja Mane, MBBS, MD, PGDAP, FRIPH
Zambia2 sites, 2 recruiting
- Recruiting
University of Zambia, School of Medicine
Lusaka
Chishala Chabala, MBChB MMed MSc, +260977849537, cchabala@gmail.com
Chishala Chabala, MBChB MMed MSc
- Recruiting
Arthur Davison Children's Hospital
Ndola
Bwendo Nduna, MBChB, MMed (Paeds), +260 96 6183841, bwendonduna@gmail.com
Indonesia1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Universitas Padjadjaran
Bandung
Rovina Ruslami, MD, PhD, +62895328254920, n.ruslami@gmail.com
Rovina Ruslami, MD, PhD
Mozambique1 site, 1 recruiting
- Recruiting
Instituto Nacional de Saúde (INS)
Maputo
Celso Khosa, MD PhD, +25821311038, celso.khosa@ins.gov.mz
Celso Khosa, MD, PhD
South Africa1 site, 1 recruiting
- Recruiting
Africa Health Research Institute (AHRI)
Durban
Moherndran Archary, MBChB PhD, +270312604318, mo.archary@ahri.org
Moherndran Archary, MBChB, PhD
Uganda1 site, 1 recruiting
- Recruiting
MU-JHU Care Ltd
Kampala
Eric Wobudeya, MD, +256708162351, ewobudeya@mujhu.org
Eric Wobudeya, MBChB MMed MSc
Zimbabwe1 site, 1 recruiting
- Recruiting
Harare Health and Research Consortium (HHRC)
Harare
Sukunena Maturure, RN, +263 772601735, smaturure@uz-ctrc.org
Mutsa Bwakura-Dangarembizi, MBChB, MMed (Paeds)
About this study
While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.
Read the detailed description
In previously untreated individuals with presumed drug-susceptible pulmonary and or peripheral lymph node TB treated with eight weeks of rifapentine, isoniazid, pyrazinamide and moxifloxacin (2HPZM), all given daily throughout, the proportion of participants who experience absence of cure (unsuccessful outcome) will not be inferior to that observed in participants who are treated with the standard regimen (eight weeks of rifampin, isoniazid, pyrazinamide, with or without ethambutol followed by 8 to 16 weeks of rifampin plus isoniazid depending on disease severity) all given daily throughout.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Lymph Node, Mycobacterium Tuberculosis
- Being tested
- Isoniazid, Rifampin, Pyrazinamide, Ethambutol, Rifapentine
- Keywords
- tuberculosis, pediatric, stratified medicine, shortened regimen, rifapentine, moxifloxacin, dolutegravir, drug-susceptible, lymph node, pulmonary, infections, TB, mycobacterium infections, respiratory tract infections, lung diseases, antitubercular agents, respiratory tract diseases, child, paediatric
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Lymph Node, Infections, Mycobacterium Infections, Respiratory Tract Infections, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
Also called H
Once daily weight-based dose
RifampinDrug
Also called R
Once daily weight-based dose
PyrazinamideDrug
Also called Z
Once daily weight-based dose
EthambutolDrug
Also called E
Once daily weight-based dose
RifapentineDrug
Also called P, Priftin
Once daily weight-based dose
MoxifloxacinDrug
Also called M, Avelox
Once daily weight-based dose
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1: Isoniazid (H), Rifampin (R), Pyrazinamide (Z), Ethambutol (E) | Active comparator | 8 weeks of daily HRZ(E) followed by either 16 or 24 weeks of daily HR, per local standard of care Receives: Drug: Isoniazid; Drug: Rifampin; Drug: Pyrazinamide; Drug: Ethambutol |
| Regimen 2: Isoniazid (H), Rifapentine (P), Pyrazinamide (Z), Moxifloxacin (M) | Experimental | 8 weeks of daily HPZM Receives: Drug: Isoniazid; Drug: Pyrazinamide; Drug: Rifapentine; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB disease-free survival at 48-weeks
Non-inferiority will be assessed by comparing the upper bound of a 95%, 2-sided confidence interval for the difference between the proportion of participants who are classified as having an unsuccessful outcome on the control regimen (HRZ(E)) and the intervention regimen (HPZM) to the predefined non-inferiority margin of 6% at 48 weeks.
Measured: Measured from study entry through week 48
Proportion of participants with grade 3 or higher adverse events over 28 weeks
The proportion of participants with a Grade 3 or higher adverse event and the corresponding 95% confidence intervals will be generated. An exact test for equality of proportions will be used to compare safety outcomes between the arms.
Measured: Measured from study entry through Week 28
Secondary outcomes (14)
TB disease-free survival at 48-weeks
Non-inferiority will be assessed by comparing the upper bound of a 95%, 2-sided confidence interval for the difference between the proportion of participants who are classified as having an unsuccessful outcome on the control regimen (HRZ(E)) and the intervention regimen (HPZM) to the predefined non-inferiority margin of 6% at 48 weeks.
Measured: Measured from study entry through Week 48
TB disease-free survival at 72-weeks
Non-inferiority will be assessed by comparing the upper bound of a 95%, 2-sided confidence interval for the difference between the proportion of participants who are classified as having an unsuccessful outcome on the control regimen (HRZ(E)) and the intervention regimen (HPZM) to the predefined non-inferiority margin of 6% at 72 weeks.
Measured: Measured from study entry through Week 72
Adherence to treatment regimens
The per-protocol analysis will account for variations in adherence to the treatment regimens. Inverse probability of treatment weighting (IPTW) using propensity scores will be applied and the net difference in treatment failure rates between the two treatment regimens and the 95% confidence interval around this will be calculated to determine non-inferiority.
Measured: Measured from study entry through Week 48
Tolerability as assessed by proportion of participants who discontinue treatment
Tolerability will be assessed as discontinuation of the assigned treatment for a reason other than microbiological ineligibility (AEs assessed as related to the study regimen that led to permanent discontinuation of the regimen, participant refusal, parent/guardian prematurely discontinues, etc.) among the modified intention-to-treat population. Proportion of participants who discontinue the assigned study regimen and the corresponding 95% confidence intervals will be generated. The control regimen (HRZ(E)) will be compared against the intervention regimen (HPZM) using an exact test for equality of proportions.
Measured: Week 8 (intervention/HPZM) or Week 16 or Week 24 (control/HRZ(E))
Rifapentine Area under the curve (AUC0-24)
Area under the curve from start of dose to 24 hours post-dose. Measured at Week 4 or Week 8. Blood samples drawn at 0, 1 minute, 2 minutes, 4 hours and 6 hours post dose.
Measured: Measured from study entry through Week 8
Rifapentine minimal concentration (Cmin)
Minimal concentration from start of dose to 24 hours post-dose. Measured at Week 4 or Week 8. Blood samples drawn at 0, 1 minute, 2 minutes, 4 hours and 6 hours post dose.
Measured: Measured from study entry through Week 8
Rifapentine peak concentration (Cmax)
Peak concentration from start of dose to 24 hours post-dose. Measured at Week 4 or Week 8. Blood samples drawn at 0, 1 minute, 2 minutes, 4 hours and 6 hours post dose.
Measured: Measured from study entry through Week 8
Moxifloxacin AUC0-24
Area under the curve from start of dose to 24 hours post-dose. Measured at Week 4 or Week 8. Blood samples drawn at 0, 1 minute, 2 minutes, 4 hours and 6 hours post dose.
Measured: Measured from study entry through Week 8
Moxifloxacin Cmin
Minimal concentration from start of dose to 24 hours post-dose. Measured at Week 4 or Week 8. Blood samples drawn at 0, 1 minute, 2 minutes, 4 hours and 6 hours post dose.
Measured: Measured from study entry through Week 8
Moxifloxacin Cmax
Peak concentration from start of dose to 24 hours post-dose. Measured at Week 4 or Week 8. Blood samples drawn at 0, 1 minute, 2 minutes, 4 hours and 6 hours post dose.
Measured: Measured from study entry through Week 8
Parent/guardian and/or participant reported palatability and acceptability of study regimen
Based on questionnaire developed by study team, data will be aggregated to measure acceptability at Entry, Week 4, and Week 8 (all participants), and Weeks 16 and 24 (for those who continue on HRZ(E) only). Scoring based on a likert or likert-like scale for each question. Each question is scored 1 to 5 with higher scores reflecting increased acceptability.
Measured: Baseline, Week 4, Week 8 (Regimens 1 and 2) and at Weeks 16 and 24 (Regimen 1 only)
Adherence as assessed by proportion of participants who have taken at least 90% of their doses
Adherence measures will be documented by a treatment supporter on a TB treatment card (as per local practice), by pill count and by an adherence questionnaire and descriptively summarized for all participants. Participants are considered adherent who have taken at least 90% of their doses within the 8 week, 16 week or 24-week time frame of their regimen.
Measured: Baseline through Week 8 for HPZM, Week 16 for HRZ(E) with non-severe disease, or Week 24 for HRZ(E) with severe disease
Risk Stratification Algorithm
If the study outcome is not non-inferior, pragmatic, programmatically available data will be considered for inclusion in a risk stratification algorithm that would aim to identify children at high risk of unsuccessful TB treatment outcome who may benefit from a longer duration of therapy. The efficacy endpoint will be analyzed using mixed-effects logistic regression models to identify predictors. The models will be adjusted for World Bank country income categories and by site using random intercepts. Univariable and multivariable analysis will be performed. The association between baseline clinical predictors and unsuccessful treatment outcomes will be analyzed, Treatment characteristics will then be added to the models to determine if treatment helped in the description of the primary efficacy endpoint.
Measured: Measured from study entry through Week 48
Cost effectiveness as assessed by the incremental cost-effective ratio (ICER)
ICER: Total costs of HPZM minus the total costs 16 or 24 week HRZE, divided by the total number of disability-adjusted life-year (DALY) averted for HPZM minus the total DALYs averted for 16- or 24-week HRZE.
Measured: Measured from study entry through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start15 Jan 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (74)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- International, multicenter, randomized, controlled, open-label, non-inferiority
- Masking
- None (open label)
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Nicole Salazar-Austin, MD, ScM, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253715
- Sponsor's protocol ID
- IRB00388853
- Acronym
- SMILE-TB
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Make individual participant data, after de-identification, publicly available in accordance with USAID's policy on data sharing.
Publications
Avelox package insert. U.S. Food and Drug Administration. (2016). Label: Avelox (moxifloxacin hydrochloride) tablets. URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s063lbl.pdf
Baciewicz AM, Self TH. Isoniazid interactions. South Med J. 1985 Jun;78(6):714-8. doi: 10.1097/00007611-198506000-00025.
PubMed 3890202Ball P. Moxifloxacin (Avelox): an 8-methoxyquinolone antibacterial with enhanced potency. Int J Clin Pract. 2000 Jun;54(5):329-32.
PubMed 10954961Berg A, Clary J, Hanna D, Nuermberger E, Lenaerts A, Ammerman N, Ramey M, Hartley D, Hermann D. Model-Based Meta-Analysis of Relapsing Mouse Model Studies from the Critical Path to Tuberculosis Drug Regimens Initiative Database. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0179321. doi: 10.1128/AAC.01793-21. Epub 2022 Jan 31.
PubMed 35099274Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, Jasmer RM, Koppaka V, Menzies RI, O'Brien RJ, Reves RR, Reichman LB, Simone PM, Starke JR, Vernon AA; American Thoracic Society, Centers for Disease Control and Prevention and the Infectious Diseases Society. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med. 2003 Feb 15;167(4):603-62. doi: 10.1164/rccm.167.4.603. No abstract available.
PubMed 12588714Burman WJ, Goldberg S, Johnson JL, Muzanye G, Engle M, Mosher AW, Choudhri S, Daley CL, Munsiff SS, Zhao Z, Vernon A, Chaisson RE. Moxifloxacin versus ethambutol in the first 2 months of treatment for pulmonary tuberculosis. Am J Respir Crit Care Med. 2006 Aug 1;174(3):331-8. doi: 10.1164/rccm.200603-360OC. Epub 2006 May 4.
PubMed 16675781Centers for Disease Control and Prevention. (2023, March 22). Tuberculosis (TB) Treatment, Treatment for TB Disease. https://www.cdc.gov/tb/topic/treatment/tbdisease.htm
Combs DL, O'Brien RJ, Geiter LJ. USPHS Tuberculosis Short-Course Chemotherapy Trial 21: effectiveness, toxicity, and acceptability. The report of final results. Ann Intern Med. 1990 Mar 15;112(6):397-406. doi: 10.7326/0003-4819-76-3-112-6-397.
PubMed 2155569Conde MB, Efron A, Loredo C, De Souza GR, Graca NP, Cezar MC, Ram M, Chaudhary MA, Bishai WR, Kritski AL, Chaisson RE. Moxifloxacin versus ethambutol in the initial treatment of tuberculosis: a double-blind, randomised, controlled phase II trial. Lancet. 2009 Apr 4;373(9670):1183-9. doi: 10.1016/S0140-6736(09)60333-0.
PubMed 19345831Donald PR, Maritz JS, Diacon AH. The pharmacokinetics and pharmacodynamics of rifampicin in adults and children in relation to the dosage recommended for children. Tuberculosis (Edinb). 2011 May;91(3):196-207. doi: 10.1016/j.tube.2011.02.004. Epub 2011 Mar 22.
PubMed 21429802Dooley KE, Park JG, Swindells S, Allen R, Haas DW, Cramer Y, Aweeka F, Wiggins I, Gupta A, Lizak P, Qasba S, van Heeswijk R, Flexner C; ACTG 5267 Study Team. Safety, tolerability, and pharmacokinetic interactions of the antituberculous agent TMC207 (bedaquiline) with efavirenz in healthy volunteers: AIDS Clinical Trials Group Study A5267. J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):455-62. doi: 10.1097/QAI.0b013e3182410503.
PubMed 22126739Dooley KE, Bliven-Sizemore EE, Weiner M, Lu Y, Nuermberger EL, Hubbard WC, Fuchs EJ, Melia MT, Burman WJ, Dorman SE. Safety and pharmacokinetics of escalating daily doses of the antituberculosis drug rifapentine in healthy volunteers. Clin Pharmacol Ther. 2012 May;91(5):881-8. doi: 10.1038/clpt.2011.323.
PubMed 22472995Dooley KE, Kaplan R, Mwelase N, Grinsztejn B, Ticona E, Lacerda M, Sued O, Belonosova E, Ait-Khaled M, Angelis K, Brown D, Singh R, Talarico CL, Tenorio AR, Keegan MR, Aboud M; International Study of Patients with HIV on Rifampicin ING study group. Dolutegravir-based Antiretroviral Therapy for Patients Coinfected With Tuberculosis and Human Immunodeficiency Virus: A Multicenter, Noncomparative, Open-label, Randomized Trial. Clin Infect Dis. 2020 Feb 3;70(4):549-556. doi: 10.1093/cid/ciz256.
PubMed 30918967Dorman SE, Goldberg S, Stout JE, Muzanyi G, Johnson JL, Weiner M, Bozeman L, Heilig CM, Feng PJ, Moro R, Narita M, Nahid P, Ray S, Bates E, Haile B, Nuermberger EL, Vernon A, Schluger NW; Tuberculosis Trials Consortium. Substitution of rifapentine for rifampin during intensive phase treatment of pulmonary tuberculosis: study 29 of the tuberculosis trials consortium. J Infect Dis. 2012 Oct 1;206(7):1030-40. doi: 10.1093/infdis/jis461. Epub 2012 Jul 30.
PubMed 22850121Dorman SE, Savic RM, Goldberg S, Stout JE, Schluger N, Muzanyi G, Johnson JL, Nahid P, Hecker EJ, Heilig CM, Bozeman L, Feng PJ, Moro RN, MacKenzie W, Dooley KE, Nuermberger EL, Vernon A, Weiner M; Tuberculosis Trials Consortium. Daily rifapentine for treatment of pulmonary tuberculosis. A randomized, dose-ranging trial. Am J Respir Crit Care Med. 2015 Feb 1;191(3):333-43. doi: 10.1164/rccm.201410-1843OC.
PubMed 25489785