Evidence map›Paper›PMID 17452486›Full record

Trial reportAntimicrobial agents and chemotherapy2007

Pharmacokinetics and tolerability of a higher rifampin dose versus the standard dose in pulmonary tuberculosis patients.

Rovina Ruslami, Hanneke M J Nijland, Bachti Alisjahbana, Ida Parwati, Reinout van Crevel, Rob E Aarnoutse

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2007. 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 81 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 4 pooled it
3.4field-weighted citation impact, top 7% 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.

NCT00760149 phase2completednot on this mapstarted 2010, after this paper: background citation

Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania.

TypeinterventionalSponsorRadboud University Medical CenterRan2010 to 2013Enrolled150ConditionsTuberculosisArmsRifampicin in higher doses
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

81 citing papers in PubMed, 4 syntheses or guidelines pooled it, 179 citations in OpenAlex.

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  3. A systematic review and meta-analysis of first-line tuberculosis drug concentrations and treatment outcomes.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2020
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  19. 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
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21 more citing papers are in PubMed but not listed here.

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

6 authors at 3 institutions in 2 countries.

Rovina RuslamiDepartment of Pharmacology, Medical Faculty, University of Padjadjaran, Bandung, Indonesia.
Hanneke M J Nijland
Bachti Alisjahbana
Ida Parwati
Reinout van Crevel
Rob E Aarnoutse
Radboud University Nijmegen · NLDr. Hasan Sadikin General Hospital · IDPadjadjaran University · ID

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Rifampin is a key drug for tuberculosis (TB) treatment. The available data suggest that the currently applied 10-mg/kg of body weight dose of rifampin may be too low and that increasing the dose may shorten the treatment duration. A double-blind randomized phase II clinical trial was performed to investigate the effect of a higher dose of rifampin in terms of pharmacokinetics and tolerability. Fifty newly diagnosed adult Indonesian TB patients were randomized to receive a standard (450-mg, i.e., 10-mg/kg in Indonesian patients) or higher (600-mg) dose of rifampin in addition to other TB drugs. A full pharmacokinetic curve for rifampin, pyrazinamide, and ethambutol was recorded after 6 weeks of daily TB treatment. Tolerability was assessed during the 6-month treatment period. The geometric means of exposure to rifampin (area under the concentration-time curve from 0 to 24 h [AUC(0-24)]) were increased by 65% (P < 0.001) in the higher-dose group (79.7 mg.h/liter) compared to the standard-dose group (48.5 mg.h/liter). Maximum rifampin concentrations (C(max)) were 15.6 mg/liter versus 10.5 mg/liter (49% increase; P < 0.001). The percentage of patients for whom the rifampin C(max) was > or =8 mg/liter was 96% versus 79% (P = 0.094). The pharmacokinetics of pyrazinamide and ethambutol were similar in both groups. Mild (grade 1 or 2) hepatotoxicity was more common in the higher-dose group (46 versus 20%; P = 0.054), but no patient developed severe hepatotoxicity. Increasing the rifampin dose was associated with a more than dose-proportional increase in the mean AUC(0-24) and C(max) of rifampin without affecting the incidence of serious adverse effects. Follow-up studies are warranted to assess whether high-dose rifampin may enable shortening of TB treatment.

Indexed as

Drug ToleranceAdolescentAdultAntibiotics, AntitubercularAntitubercular AgentsArea Under CurveBiological AvailabilityDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationEthambutolFemaleHalf-LifeHumansIsoniazidAntibiotics, AntitubercularAntitubercular AgentsEthambutolIsoniazidPyrazinamideRifampin

Identifiers

PMID17452486
PMCPMC1913243
OpenAlexW2112348327

What OpenQuestion holds

Textmetadata
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.