Evidence map›Paper›PMID 29954183›Full record

Trial reportAmerican journal of respiratory and critical care medicine2018

Efficacy and Safety of High-Dose Rifampin in Pulmonary Tuberculosis. A Randomized Controlled Trial.

Gustavo E Velásquez, Meredith B Brooks, Julia M Coit, Henry Pertinez, Dante Vargas Vásquez, Epifanio Sánchez Garavito, Roger I Calderón, Judith Jiménez, Karen Tintaya, Charles A Peloquin and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03988933 (2R2), which is not on this map. Cited by 61 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT03988933 phase2completednot on this mapstarted 2019, after this paper: background citation

2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB: a 3-arm Randomized Trial.

TypeinterventionalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2019 to 2024Enrolled1,368ConditionsLatent TuberculosisArmsRifampin double dose, Rifampin triple dose, Rifampin standard dose
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Safety of Triple-Dose Rifampin in Tuberculosis Treatment: A Systematic Review and Meta-Analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
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  9. 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 · 2024
    Trial
  10. Trial
  11. Trial
  12. Review
  13. Insights into the Role of Rifampicin Exposure and Clinical Baseline Covariates on the Response to Pulmonary Tuberculosis Treatment.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  14. Article
  15. Pharmacokinetic and pharmacogenomic predictors of hepatotoxicity in the HIRIF trial for drug-susceptible tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  16. Article
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  18. Article
  19. Therapeutic drug monitoring in tuberculosis.European journal of clinical pharmacology · 2024
    Review
  20. Article

1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Gustavo E Velásquez1 Division of Infectious Diseases and.ORCID 0000-0003-1438-0692
Meredith B Brooks2 Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts.
Julia M Coit2 Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts.
Henry Pertinez3 Institute of Infection and Global Health and.
Dante Vargas Vásquez5 Hospital Nacional Hipólito Unanue, Lima, Peru.
Epifanio Sánchez Garavito6 Hospital Nacional Sergio Bernales, Lima, Peru.
Roger I Calderón7 Partners in Health/Socios en Salud Sucursal Peru, Lima, Peru.
Judith Jiménez7 Partners in Health/Socios en Salud Sucursal Peru, Lima, Peru.
Karen Tintaya7 Partners in Health/Socios en Salud Sucursal Peru, Lima, Peru.
Charles A Peloquin8 College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, Florida; and.
Elna Osso2 Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts.
Dylan B Tierney9 Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts.
Kwonjune J Seung9 Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts.
Leonid Lecca2 Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts.
Geraint R Davies3 Institute of Infection and Global Health and.
Carole D Mitnick9 Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts.

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Randomized Trial of High-Dose Rifampin in Patients with New Smear-Positive TBU01AI091429 · NIAID · HARVARD MEDICAL SCHOOL · PI DAVIES, GERAINT, MITNICK, CAROLE D. · 2011 to 2013
$8.5M
NIAID NIH HHS L30 AI120170NIAID NIH HHS U01 AI091429NIAID NIH HHS UM1 AI068636
6 · The paper itself

Abstract

rationaleWe examined whether increased rifampin doses could shorten standard therapy for tuberculosis without increased toxicity.

objectivesTo assess the differences across three daily oral doses of rifampin in change in elimination rate of Mycobacterium tuberculosis in sputum and frequency of rifampin-related adverse events.

methodsWe conducted a blinded, randomized, controlled phase 2 clinical trial of 180 adults with new smear-positive pulmonary tuberculosis, susceptible to isoniazid and rifampin. We randomized 1:1:1 to rifampin at 10, 15, and 20 mg/kg/d during the intensive phase. We report the primary efficacy and safety endpoints: change in elimination rate of M. tuberculosis log MEASUREMENTS AND MAIN

resultsEach 5-mg/kg/d increase in rifampin dose resulted in differences of -0.011 (95% confidence interval, -0.025 to +0.002; P = 0.230) and -0.022 (95% confidence interval, -0.046 to -0.002; P = 0.022) log

conclusionsOur findings of more rapid sputum sterilization and similar toxicity with higher rifampin doses support investigation of increased rifampin doses to shorten tuberculosis treatment. Clinical trial registered with www.clinicaltrials.gov (NCT 01408914) .

Indexed as

AdultAntibiotics, AntitubercularFemaleHumansMaleMycobacterium tuberculosisRifampinSputumTreatment OutcomeTuberculosis, PulmonaryYoung AdultAntibiotics, AntitubercularRifampinadverse drug eventrandomized controlled trialrifampintreatment efficacytuberculosis

Identifiers

PMID29954183
PMCPMC6118011

What OpenQuestion holds

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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.