Evidence map›Paper›PMID 34843388›Full record

ArticleAntimicrobial agents and chemotherapy2022

Population Pharmacokinetic and Concentration-QTc Analysis of Delamanid in Pediatric Participants with Multidrug-Resistant Tuberculosis.

Tomohiro Sasaki, Elin M Svensson, Xiaofeng Wang, Yanlin Wang, Jeffrey Hafkin, Mats O Karlsson, Suresh Mallikaarjun

Open access · hybridAbstract read
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 23% 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.

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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Delamanid-containing regimens and multidrug-resistant tuberculosis: A systematic review and meta-analysis.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. The cascade of care for household contacts of people with drug-resistant TB.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
    Article
  12. 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 at 3 institutions in 4 countries.

Tomohiro SasakiOtsuka Pharmaceutical Co., Ltd., Osaka, Japan.ORCID 0000-0002-0619-7057
Elin M SvenssonDepartment of Pharmacy, Uppsala Universitygrid.8993.b, Uppsala, Sweden.
Xiaofeng WangOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.ORCID 0000-0002-0890-3197
Yanlin WangOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.
Jeffrey HafkinOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.
Mats O KarlssonDepartment of Pharmacy, Uppsala Universitygrid.8993.b, Uppsala, Sweden.
Suresh MallikaarjunOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.
Pharmaceutical Product Development (United States) · USUppsala University · SEOtsuka (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A population pharmacokinetic analysis of delamanid and its major metabolite DM-6705 was conducted to characterize the pharmacokinetics of delamanid and DM-6705 in pediatric participants with multidrug-resistant tuberculosis (MDR-TB). Data from participants between the ages of 0.67 and 17 years, enrolled in 2 clinical trials, were utilized for the analysis. The final data set contained 634 delamanid and 706 DM-6705 valid plasma concentrations from 37 children. A transit model with three compartments best described the absorption of delamanid. Two-compartment models for each component with linear elimination were selected to characterize the dispositions of delamanid and DM-6705, respectively. The covariates included in the model were body weight on the apparent volume of distribution and apparent clearance (for both delamanid and DM-6705); formulation (dispersible versus film-coated tablet) on the mean absorption time; age, formulation, and dose on the bioavailability of delamanid; and age on the fraction of delamanid metabolized to DM-6705. Based on the simulations, doses for participants within different age/weight groups that result in delamanid exposure comparable to that in adults following the approved adult dose were calculated. By concentration-QTc (QTcB [QT corrected by Bazett's formula]) analysis, a significant positive correlation was detected with concentrations of DM-6705. However, the model-predicted upper bounds of the 90% confidence intervals of ΔQTc values were <10 ms at the simulated maximum concentration (

Indexed as

NitroimidazolesTuberculosis, Multidrug-ResistantAdolescentAdultAntitubercular AgentsChildChild, PreschoolHumansInfantOxazolesAntitubercular AgentsNitroimidazolesOPC-67683OxazolesdelamanidMycobacterium tuberculosispediatric drug therapyPK/QTcpopulation PK

Identifiers

PMID34843388
PMCPMC8846319
OpenAlexW3216999388

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.