Evidence map›Paper›PMID 30287613›Full record

ArticleBMJ open2018

Plasma concentrations of second-line antituberculosis drugs in relation to minimum inhibitory concentrations in multidrug-resistant tuberculosis patients in China: a study protocol of a prospective observational cohort study.

Lina Davies Forsman, Katarina Niward, Yi Hu, Rongrong Zheng, Xubin Zheng, Ran Ke, Weiping Cai, Chao Hong, Yang Li, Yazhou Gao and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02816931 (Plasma Drug Concentrations in the Treatment of Multidrug-resistant Tuberculosis in Relation to Minimum Inhibitory Concentrations - a Prospective Observational Study), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 25% 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.

NCT02816931 completednot on this map

Plasma Drug Concentrations in the Treatment of Multidrug-resistant Tuberculosis in Relation to Minimum Inhibitory Concentrations - a Prospective Observational Study

TypeobservationalSponsorKarolinska InstitutetRan2016 to 2020Enrolled37ConditionsTuberculosis, Multidrug Resistant
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
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

21 authors at 7 institutions in 3 countries.

Lina Davies ForsmanDivision of Infectious Diseases, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.
Katarina NiwardDepartment of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
Yi HuDepartment of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety, Fudan University, Shanghai, China.
Rongrong ZhengDepartment of Tuberculosis and AIDS prevention, Xiamen City Centre for Disease Control, Xiamen, China.
Xubin ZhengDepartment of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety, Fudan University, Shanghai, China.
Ran KeDepartment of Tuberculosis and AIDS prevention, Xiamen City Centre for Disease Control, Xiamen, China.
Weiping CaiDepartment of Tuberculosis and AIDS prevention, Xiamen City Centre for Disease Control, Xiamen, China.
Chao HongDepartment of Tuberculosis and AIDS prevention, Xiamen City Centre for Disease Control, Xiamen, China.
Yang LiDepartment of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety, Fudan University, Shanghai, China.
Yazhou GaoDepartment of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety, Fudan University, Shanghai, China.
Jim WerngrenDepartment of Microbiology, The Public Health Agency of Sweden, Stockholm, Sweden.
Jakob PauesDepartment of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
Johanna KuhlinDivision of Infectious Diseases, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.
Ulrika S H SimonssonDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Erik EliassonDivision of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska University Hospital, Stockholm, Sweden.
Jan-Willem AlffenaarDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Mikael MansjöDepartment of Microbiology, The Public Health Agency of Sweden, Stockholm, Sweden.
Sven HoffnerDepartment of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
Biao XuDepartment of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety, Fudan University, Shanghai, China.
Thomas SchönDepartment of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
Judith BruchfeldDivision of Infectious Diseases, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.
Fudan University · CNKarolinska University Hospital · SELinköping University · SEKarolinska Institutet · SEPublic Health Agency of Sweden · SEUniversity of Groningen · NLUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIndividualised treatment through therapeutic drug monitoring (TDM) may improve tuberculosis (TB) treatment outcomes but is not routinely implemented. Prospective clinical studies of drug exposure and minimum inhibitory concentrations (MICs) in multidrug-resistant TB (MDR-TB) are scarce. This translational study aims to characterise the area under the concentration-time curve of individual MDR-TB drugs, divided by the MIC for METHODS AND ANALYSIS: Adult patients with pulmonary MDR-TB treated in Xiamen, China, are included. Plasma samples for measure of drug exposure are obtained at 0, 1, 2, 4, 6, 8 and 10 hours after drug intake at week 2 and at 0, 4 and 6 hours during weeks 4 and 8. Sputum samples for evaluating time to culture positivity and MIC determination are collected at days 0, 2 and 7 and at weeks 2, 4, 8 and 12 after treatment initiation. Disease severity are assessed with a clinical scoring tool (TBscore II) and quality of life evaluated using EQ-5D-5L. Drug concentrations of pyrazinamide, ethambutol, levofloxacin, moxifloxacin, cycloserine, prothionamide and para-aminosalicylate are measured by liquid chromatography tandem-mass spectrometry and the levels of amikacin measured by immunoassay. Dried blood spot on filter paper, to facilitate blood sampling for analysis of drug concentrations, is also evaluated. The MICs of the drugs listed above are determined using custom-made broth microdilution plates and MYCOTB plates with Middlebrook 7H9 media. MIC determination of pyrazinamide is performed in BACTEC MGIT 960. ETHICS AND DISSEMINATION: This study has been approved by the ethical review boards of Karolinska Institutet, Sweden and Fudan University, China. Informed written consent is given by participants. The study results will be submitted to a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02816931; Pre-results.

Indexed as

Antitubercular AgentsDrug MonitoringMycobacterium tuberculosisTuberculosis, Multidrug-ResistantAdultChinaCohort StudiesFemaleHumansMaleMicrobial Sensitivity TestsObservational Studies as TopicProspective StudiesSerum Bactericidal TestAntitubercular Agentsclinical pharmacologymicrobiologypublic healthtuberculosis

Identifiers

PMID30287613
PMCPMC6173237
OpenAlexW2894563875

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.