Evidence map›Paper›PMID 34916467›Full record

Trial reportInternational journal of mycobacteriology

Pharmacodynamic biomarkers for quantifying the mycobacterial effect of high doses of rifampin in patients with rifampin-susceptible pulmonary tuberculosis.

Bibie N Said, Scott K Heysell, Getnet Yimer, Rob E Aarnoutse, Gibson S Kibiki, Stellah Mpagama, Peter M Mbelele

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of mycobacteriology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Multidrug-resistant tuberculosis.Nature reviews. Disease primers · 2024
    Review
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

7 authors.

Bibie N SaidKibong'oto Infectious Diseases Hospital (KIDH), Research Department, Siha, Kilimanjaro, Tanzania; Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Charlottesville, Virginia, USA.
Scott K HeysellDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia, USA.
Getnet YimerCenter for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Charlottesville, Virginia; Global One Health initiative, Office of International Affairs, The Ohio State University, Columbus, Ohio, USA.
Rob E AarnoutseRadboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the, Netherlands.
Gibson S KibikiKilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Tumaini University, Moshi, Tanzania.
Stellah MpagamaKibong'oto Infectious Diseases Hospital (KIDH), Research Department, Siha, Kilimanjaro, Tanzania.
Peter M MbeleleKibong'oto Infectious Diseases Hospital (KIDH), Research Department, Siha, Kilimanjaro; Department of Global Health and Biomedical Sciences, School of Life Sciences and Bioengineering, Nelson Mandela African Institution of Science and Technology (NM-AIST), Arusha, Tanzania.

Funding

Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and AdultsR01AI137080 · NIAID · UNIVERSITY OF VIRGINIA · PI Scott K Heysell, Leonid Kagan · 2018 to 2026
$6.3M
European & Developing Countries Clinical Trials Partnership (EDCTP) TMA2016SF-1463NIAID NIH HHS R01 AI137080
6 · The paper itself

Abstract

Background: Suboptimal drug exposure in patients with drug-susceptible tuberculosis (DS-TB) can drive treatment failure. Pharmacodynamics (PD) biomarkers such as the plasma TB drug-activity (TDA) assay may guide dose finding studies and predict microbiological outcomes differently than conventional indices. Methods: A study was nested from phase 2b randomized double-blind controlled trial of Tanzanian patients who received a 600 mg, 900 mg, or 1200 mg with a standard dose for DS-TB. Serum at 6 weeks collected over 24-h at 2-h intervals was collected for rifampin area under the concentration-time curve relative to minimum inhibitory concentration (AUC Results: Among 10 patients, 600 mg (3), 900 mg (3), and 1200 mg (4) of rifampin dosages. The mean ± standard deviation (SD) of AUC Conclusions: TDA and rifampin AUC

Indexed as

Mycobacterium tuberculosisTuberculosisTuberculosis, PulmonaryAntitubercular AgentsBiomarkersHumansRifampinAntitubercular AgentsBiomarkersRifampinMycobacterial activitypharmacodynamic biomarkerstuberculosistuberculosis drug activity

Identifiers

PMID34916467
PMCPMC7612567

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Registered trials

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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.