Evidence map›Paper›PMID 25182637›Full record

ArticleAntimicrobial agents and chemotherapy2014

Quantification of rifapentine, a potent antituberculosis drug, from dried blood spot samples using liquid chromatographic-tandem mass spectrometric analysis.

Teresa L Parsons, Mark A Marzinke, Thuy Hoang, Erin Bliven-Sizemore, Marc Weiner, William R Mac Kenzie, Susan E Dorman, Kelly E Dooley

Abstract readClinical Trial, Phase I
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 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.

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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  4. Review
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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

8 authors.

Teresa L ParsonsJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Mark A MarzinkeJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Thuy HoangJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Erin Bliven-SizemoreCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Marc WeinerVA Medical Center, San Antonio, Texas, USA.
William R Mac KenzieCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Susan E DormanJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Kelly E DooleyJohns Hopkins University School of Medicine, Baltimore, Maryland, USA kdooley1@jhmi.edu.

Funding

Multidisciplinary Clinical Research and Mentoring in Tuberculosis DiagnosticsK24AI104830 · NIAID · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DORMAN, SUSAN E · 2015 to 2019
$790k
PK/PD Issues in the Use of New Therapies for the Treatment of TuberculosisK23AI080842 · NIAID · JOHNS HOPKINS UNIVERSITY · PI DOOLEY, KELLY E. · 2009 to 2013
$670k
Applied Biosystems API5500 Triple Quadrupole Mass SpectrometerS10RR027733 · NCRR · JOHNS HOPKINS UNIVERSITY · PI HUBBARD, WALTER C · 2010 to 2010
$350k
NCRR NIH HHS 1S10 RR 27733NCRR NIH HHS S10 RR027733NIAID NIH HHS K23 AI080842NIAID NIH HHS K23AI080842NIAID NIH HHS K24 AI104830
6 · The paper itself

Abstract

The quantification of antituberculosis drug concentrations in multinational trials currently requires the collection of modest blood volumes, centrifugation, aliquoting of plasma, freezing, and keeping samples frozen during shipping. We prospectively enrolled healthy individuals into the Tuberculosis Trials Consortium Study 29B, a phase I dose escalation study of rifapentine, a rifamycin under evaluation in tuberculosis treatment trials. We developed a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantifying rifapentine in whole blood on dried blood spots (DBS) to facilitate pharmacokinetic/pharmacodynamic analyses in clinical trials. Paired plasma and whole-blood samples were collected by venipuncture, and whole blood was spotted on Whatman protein saver 903 cards. The methods were optimized for plasma and then validated for DBS. The analytical measuring range for quantification of rifapentine and its metabolite was 50 to 80,000 ng/ml in whole-blood DBS. The analyte was stable on the cards for 11 weeks with a desiccant at room temperature and protected from light. The method concordance for paired plasma and whole-blood DBS samples was determined after correcting for participant hematocrit or population-based estimates of bias from Bland-Altman plots. The application of either correction factor resulted in acceptable correlation between plasma and whole-blood DBS (Passing-Bablok regression corrected for hematocrit; y = 0.98x + 356). Concentrations of rifapentine may be determined from whole-blood DBS collected via venipuncture after normalization in order to account for the dilutional effects of red blood cells. Additional studies are focused on the application of this methodology to capillary blood collected by finger stick. The simplicity of processing, storage, shipping, and low blood volume makes whole-blood DBS attractive for rifapentine pharmacokinetic evaluations, especially in international and pediatric trials.

Indexed as

Antitubercular AgentsChromatography, LiquidDried Blood Spot TestingDrug MonitoringHigh-Throughput Screening AssaysHumansProspective StudiesReproducibility of ResultsRifampinTandem Mass SpectrometryTuberculosis, PulmonaryAntitubercular AgentsRifampinrifapentine

Identifiers

PMID25182637
PMCPMC4249427

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.