Evidence map›Paper›PMID 28827417›Full record

Trial reportAntimicrobial agents and chemotherapy2017

Pharmacokinetics, Tolerability, and Bacteriological Response of Rifampin Administered at 600, 900, and 1,200 Milligrams Daily in Patients with Pulmonary Tuberculosis.

R E Aarnoutse, G S Kibiki, K Reither, H H Semvua, F Haraka, C M Mtabho, S G Mpagama, J van den Boogaard, I M Sumari-de Boer, C Magis-Escurra and 10 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2017. 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 51 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 8 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

51 citing papers in PubMed, 8 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. Effectiveness and Pharmacokinetic Exposures of First-Line Drugs Used to Treat Drug-Susceptible Tuberculosis in Children: A Systematic Review and Meta-Analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Pooled it
  6. Pooled it
  7. Treatment Effect Measures for Culture Conversion Endpoints in Phase IIb Tuberculosis Treatment Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Pooled it
  8. Pooled it
  9. Trial
  10. 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
  11. Trial
  12. Efficacy and Safety of High-Dose Rifampin in Pulmonary Tuberculosis. A Randomized Controlled Trial.American journal of respiratory and critical care medicine · 2018
    Trial
  13. Trial
  14. Review
  15. 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
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

R E AarnoutseRadboud University Medical Center, Department of Pharmacy, Nijmegen, the Netherlands.
G S KibikiKilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Tumaini University, Moshi, Tanzania.
K ReitherSwiss Tropical and Public Health Institute, Basel, Switzerland.
H H SemvuaKilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Tumaini University, Moshi, Tanzania.
F HarakaIfakara Health Institute, Bagamoyo, Tanzania.
C M MtabhoKilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Tumaini University, Moshi, Tanzania.
S G MpagamaKibong'oto National Tuberculosis Hospital, Sanya Juu, Tanzania.
J van den BoogaardKilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Tumaini University, Moshi, Tanzania.
I M Sumari-de BoerKilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Tumaini University, Moshi, Tanzania.
C Magis-EscurraRadboud University Medical Center, Department of Lung Diseases, Nijmegen, the Netherlands.
M WattenbergRadboud University Medical Center, Department of Medical Microbiology, Nijmegen, the Netherlands.
J G M LoggerRadboud University Medical Center, Department of Pharmacy, Nijmegen, the Netherlands.
L H M Te BrakeRadboud University Medical Center, Department of Pharmacy, Nijmegen, the Netherlands Lindsey.teBrake@radboudumc.nl.
M HoelscherMedical Centre of the University of Munich (LMU), Division of Infectious Diseases and Tropical Medicine, Munich, Germany.
S H GillespieSchool of Medicine, University of St. Andrews, North Haugh, St. Andrews, United Kingdom.
A ColbersRadboud University Medical Center, Department of Pharmacy, Nijmegen, the Netherlands.
P P J PhillipsMRC Clinical Trials Unit at UCL, London, United Kingdom.
G Plemper van BalenRadboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.
M J BoereeRadboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.
PanACEA Consortium

Funding

Medical Research Council MC_UU_12023/27
6 · The paper itself

Abstract

In a multiple-dose-ranging trial, we previously evaluated higher doses of rifampin in patients for 2 weeks. The objectives of the current study were to administer higher doses of rifampin for a longer period to compare the pharmacokinetics, safety/tolerability, and bacteriological activity of such regimens. In a double-blind, randomized, placebo-controlled, phase II clinical trial, 150 Tanzanian patients with tuberculosis (TB) were randomized to receive either 600 mg (approximately 10 mg/kg of body weight), 900 mg, or 1,200 mg rifampin combined with standard doses of isoniazid, pyrazinamide, and ethambutol administered daily for 2 months. Intensive pharmacokinetic sampling occurred in 63 patients after 6 weeks of treatment, and safety/tolerability was assessed. The bacteriological response was assessed by culture conversion in liquid and solid media. Geometric mean total exposures (area under the concentration-versus-time curve up to 24 h after the dose) were 24.6, 50.8, and 76.1 mg · h/liter in the 600-mg, 900-mg, and 1,200-mg groups, respectively, reflecting a nonlinear increase in exposure with the dose (

Indexed as

AdultAntibiotics, AntitubercularDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationEthambutolFemaleHumansIsoniazidMaleMycobacterium tuberculosisPyrazinamideRifampinTreatment OutcomeTuberculosis, PulmonaryAntibiotics, AntitubercularEthambutolIsoniazidPyrazinamideRifampindrug safetypharmacokineticsrifampintuberculosis

Identifiers

PMID28827417
PMCPMC5655063

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.