Evidence map›Paper›PMID 30870476›Full record

Observational studyPloS one2019

High-dose rifampicin in tuberculosis: Experiences from a Dutch tuberculosis centre.

Charlotte Seijger, Wouter Hoefsloot, Inge Bergsma-de Guchteneire, Lindsey Te Brake, Jakko van Ingen, Saskia Kuipers, Reinout van Crevel, Rob Aarnoutse, Martin Boeree, Cecile Magis-Escurra

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04768231 (Safety of Rifampicin at High Dose for the Treatment of Adult Subjects With Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
6.1field-weighted citation impact, top 3% of its field
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.

NCT04768231 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

Safety of Rifampicin at High Dose for the Treatment of Adult Subjects With Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis

TypeinterventionalSponsorHospital Universitari Vall d'Hebron Research InstituteRan2021 to 2023Enrolled130ConditionsTuberculosisArmsRifampin
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 70 citations in OpenAlex.

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  10. Therapeutic drug monitoring in tuberculosis.European journal of clinical pharmacology · 2024
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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

10 authors at 1 institution in 1 country.

Charlotte SeijgerDepartment of Pulmonary Diseases, Radboud University Medical Center-Dekkerswald, Nijmegen, The Netherlands.
Wouter HoefslootDepartment of Pulmonary Diseases, Radboud University Medical Center-Dekkerswald, Nijmegen, The Netherlands.
Inge Bergsma-de GuchteneireDepartment of Pulmonary Diseases, Radboud University Medical Center-Dekkerswald, Nijmegen, The Netherlands.ORCID 0000-0002-6998-7427
Lindsey Te BrakeDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
Jakko van IngenDepartment of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands.
Saskia KuipersDepartment of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands.
Reinout van CrevelDepartment of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Rob AarnoutseDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
Martin BoereeDepartment of Pulmonary Diseases, Radboud University Medical Center-Dekkerswald, Nijmegen, The Netherlands.
Cecile Magis-EscurraDepartment of Pulmonary Diseases, Radboud University Medical Center-Dekkerswald, Nijmegen, The Netherlands.
Radboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent evidence suggests that higher rifampicin doses may improve tuberculosis (TB) treatment outcome.

methodsIn this observational cohort study we evaluated all TB patients who were treated with high-dose rifampicin (> 10 mg/kg daily) in our reference centre, from January 2008 to May 2018. Indications, achieved plasma rifampicin exposures, safety and tolerability were evaluated.

resultsEighty-eight patients were included. The main indications were low plasma concentrations (64.7%) and severe illness (29.5%), including central nervous system TB. Adjusted rifampicin dosages ranged from 900 mg to a maximum of 2400 mg (corresponding to 32 mg/kg) per day. Patients with severe illness received high-dose rifampicin immediately, the others had a higher dosage guided by therapeutic drug monitoring. Four patients developed hepatotoxicity, of which two were proven due to isoniazid. Re-introduction of high-dose rifampicin was successful in all four. Eighty-seven patients tolerated high-dose rifampicin well throughout treatment. Only one patient required a dose reduction due to gastro-intestinal disturbance.

conclusionHigh-dose rifampicin, used in specific groups of patients in our clinical setting, is safe and well-tolerated for the whole treatment duration. Measurement of drug exposures could be used as a tool/guide to increase rifampicin dosage if a reduced medication absorption or a poor treatment outcome is suspected. We suggest to administer high-dose rifampicin to patients with severe manifestations of TB or low rifampicin exposure to improve treatment outcome.

Indexed as

AdolescentAdultAgedAged, 80 and overAntitubercular AgentsArea Under CurveCentral Nervous SystemCohort StudiesDrug Administration ScheduleDrug MonitoringFemaleHumansIsoniazidLiverMaleMiddle AgedAntitubercular AgentsIsoniazidRifampin

Identifiers

PMID30870476
PMCPMC6417786
OpenAlexW2921782256

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.