ArticleContemporary clinical trials2020
High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial.
Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349
Shortened Regimen for Drug-susceptible TB in Children
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- Pharmacokinetics and Dose Optimization of Ethambutol in Children on First-Line Antituberculosis Therapy: An Individual Patient Data Meta-Analysis.The Journal of infectious diseases · 2026Pooled it
- Pregnancy Outcomes after Exposure to Tuberculosis Treatment in Phase 3 Clinical Trial, 2016-2020.Emerging infectious diseases · 2025Trial
- Pyrazinamide Safety, Efficacy, and Dosing for Treating Drug-Susceptible Pulmonary Tuberculosis: A Phase 3, Randomized Controlled Clinical Trial.American journal of respiratory and critical care medicine · 2024Trial
- Risk-stratified treatment for drug-susceptible pulmonary tuberculosis.Nature communications · 2024Trial
- Pharmacokinetic-Pharmacodynamic Evidence From a Phase 3 Trial to Support Flat-Dosing of Rifampicin for Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- A Standardized Approach for Collection of Objective Data to Support Outcome Determination for Late-Phase Tuberculosis Clinical Trials.American journal of respiratory and critical care medicine · 2023Trial
- Rifapentine With and Without Moxifloxacin for Pulmonary Tuberculosis in People With Human Immunodeficiency Virus (S31/A5349).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- Efavirenz Pharmacokinetics and Human Immunodeficiency Virus Type 1 (HIV-1) Viral Suppression Among Patients Receiving Tuberculosis Treatment Containing Daily High-Dose Rifapentine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Optimizing drug inventory management with a web-based information system: The TBTC Study 31/ACTG A5349 experience.Contemporary clinical trials · 2021Trial
- Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis.The New England journal of medicine · 2021Trial
- Central monitoring in a randomized, open-label, controlled phase 3 clinical trial for a treatment-shortening regimen for pulmonary tuberculosis.Contemporary clinical trials · 2021Trial
- Decreased plasma rifapentine concentrations associated with AADAC single nucleotide polymorphism in adults with tuberculosis.The Journal of antimicrobial chemotherapy · 2021Trial
- Trials, tribulations, and formulations in access to new TB drugs for children: learning from rifapentine.IJTLD open · 2026Review
- Ethambutol Population Pharmacokinetics and Pharmacodynamics From a Phase 3 Confirmatory Trial for the Treatment of Tuberculosis.The Journal of infectious diseases · 2026Article
- Buruli ulcer.Nature reviews. Disease primers · 2025Review
- Multicentre controlled open randomised clinical trial to assess efficacy and safety of an anti-tuberculosis drug combination based on optimised-dose rifampicin, optimised-dose moxifloxacin and optimised-dose linezolid for TB: the RML-TB trial protocol.BMJ open respiratory research · 2025Article
- Diagnostics and new treatment regimens for TB: can the Xpert MTB/XDR assay fill the gap for fluoroquinolone testing?Journal of clinical microbiology · 2025Article
- ERS Congress 2024: highlights from the Respiratory Infections Assembly.ERJ open research · 2025Article
- Advancing against drug-resistant tuberculosis: an extensive review, novel strategies and patent landscape.Naunyn-Schmiedeberg's archives of pharmacology · 2025Review
- Toward better cures forClinical microbiology reviews · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
33 authors at 18 institutions in 7 countries.
Funding
Abstract
introductionPhase 2 clinical trials of tuberculosis treatment have shown that once-daily regimens in which rifampin is replaced by high dose rifapentine have potent antimicrobial activity that may be sufficient to shorten overall treatment duration. Herein we describe the design of an ongoing phase 3 clinical trial testing the hypothesis that once-daily regimens containing high dose rifapentine in combination with other anti-tuberculosis drugs administered for four months can achieve cure rates not worse than the conventional six-month treatment regimen. METHODS/
designS31/A5349 is a multicenter randomized controlled phase 3 non-inferiority trial that compares two four-month regimens with the standard six-month regimen for treating drug-susceptible pulmonary tuberculosis in HIV-negative and HIV-positive patients. Both of the four-month regimens contain high-dose rifapentine instead of rifampin, with ethambutol replaced by moxifloxacin in one regimen. All drugs are administered seven days per week, and under direct observation at least five days per week. The primary outcome is tuberculosis disease-free survival at twelve months after study treatment assignment. A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of non-inferiority. DISCUSSION: This phase 3 trial formally tests the hypothesis that augmentation of rifamycin exposures can shorten tuberculosis treatment to four months. Trial design and standardized implementation optimize the likelihood of obtaining valid results. Results of this trial may have important implications for clinical management of tuberculosis at both individual and programmatic levels.
trial registrationNCT02410772. Registered 8 April 2015,https://www.clinicaltrials.gov/ct2/show/NCT02410772?term=02410772&rank=1.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.