Evidence map›Paper›PMID 31712809›Full record

Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

Clinical Outcomes Among Patients With Drug-resistant Tuberculosis Receiving Bedaquiline- or Delamanid-Containing Regimens.

R R Kempker, L Mikiashvili, Y Zhao, D Benkeser, K Barbakadze, N Bablishvili, Z Avaliani, C A Peloquin, H M Blumberg, M Kipiani

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 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

33 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Bedaquiline-containing regimens and multidrug-resistant tuberculosis: a systematic review and meta-analysis.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2022
    Pooled it
  4. Pooled it
  5. Article
  6. Review
  7. Bedaquiline Delivery Innovations: A Review on Advancing MDR-TB Treatment Strategies.Recent advances in anti-infective drug discovery · 2025
    Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. The effect of anti-tuberculosis drug pharmacokinetics on QTc prolongation.International journal of antimicrobial agents · 2023
    Observational
  17. Review
  18. Article
  19. New and Repurposed Drugs for the Treatment of Active Tuberculosis: An Update for Clinicians.Respiration; international review of thoracic diseases · 2023
    Review
  20. 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

10 authors.

R R KempkerDepartment of Medicine, Division of Infectious Disease, Emory University School of Medicine, Atlanta, Georgia, USA.
L MikiashviliNational Center for Tuberculosis and Lung Disease, Tbilisi, Georgia.
Y ZhaoDepartment of Biostatistics and Bioinformatics, Emory Rollins School of Public Health, Atlanta, Georgia, USA.
D BenkeserDepartment of Biostatistics and Bioinformatics, Emory Rollins School of Public Health, Atlanta, Georgia, USA.
K BarbakadzeNational Center for Tuberculosis and Lung Disease, Tbilisi, Georgia.
N BablishviliNational Center for Tuberculosis and Lung Disease, Tbilisi, Georgia.
Z AvalianiNational Center for Tuberculosis and Lung Disease, Tbilisi, Georgia.
C A PeloquinDepartment of Pharmacy, University of Florida, Gainesville, Florida, USA.
H M BlumbergDepartment of Medicine, Division of Infectious Disease, Emory University School of Medicine, Atlanta, Georgia, USA.
M KipianiNational Center for Tuberculosis and Lung Disease, Tbilisi, Georgia.

Funding

Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
Emory-Georgia TB Research Training ProgramD43TW007124 · FIC · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Nestani Tukvadze · 2004 to 2026
$4.6M
Intra Cavitary Pharmacokinetics and Drug Resistance in Pulmonary TuberculosisK23AI103044 · NIAID · EMORY UNIVERSITY · PI KEMPKER, RUSSELL RYAN · 2013 to 2017
$910k
A Clinical Pharmacology Study of a Novel Drug Regimen for Pre XDR and XDR TuberculosisR21AI122001 · NIAID · EMORY UNIVERSITY · PI KEMPKER, RUSSELL RYAN · 2016 to 2017
$369k
FIC NIH HHS D43 TW007124NCATS NIH HHS UL1 TR002378NIAID NIH HHS K23 AI103044NIAID NIH HHS R21 AI122001
6 · The paper itself

Abstract

backgroundBedaquiline and delamanid are newly available drugs for treating multidrug-resistant tuberculosis (MDR-TB); however, there are limited data guiding their use and no comparison studies.

methodsWe conducted a prospective, observational study among patients with MDR-TB in Georgia who were receiving a bedaquiline- or delamanid-based treatment regimen. Monthly sputum cultures, minimal inhibitory concentration testing, and adverse event monitoring were performed. Primary outcomes were culture conversion rates and clinical outcomes. Targeted maximum likelihood estimation and super learning were utilized to produce a covariate-adjusted proportion of outcomes for each regimen.

resultsAmong 156 patients with MDR-TB, 100 were enrolled and 95 were receiving a bedaquiline-based (n = 64) or delamanid-based (n = 31) regimen. Most were male (82%) and the median age was 38 years. Rates of previous treatment (56%) and cavitary disease (61%) were high. The most common companion drugs included linezolid, clofazimine, cycloserine, and a fluoroquinolone. The median numbers of effective drugs received among patients on bedaquiline-based (4; interquartile range [IQR], 4-4) and delamanid-based (4; IQR, 3.5-5) regimens were similar. Rates of acquired drug resistance were significantly higher among patients receiving delamanid versus bedaquiline (36% vs 10%, respectively; P < .01). Adjusted rates of sputum culture conversion at 2 months (67% vs 47%, respectively; P = .10) and 6 months (95% vs 74%, respectively; P < .01), as well as more favorable clinical outcomes (96% vs 72%, respectively; P < .01), were higher among patients receiving bedaquiline versus delamanid.

conclusionsAmong patients with MDR-TB, bedaquiline-based regimens were associated with higher rates of sputum culture conversion, more favorable outcomes, and a lower rate of acquired drug resistance versus delamanid-based regimens.

Indexed as

Antitubercular AgentsTuberculosis, Multidrug-ResistantAdultDiarylquinolinesFemaleGeorgiaHumansMaleNitroimidazolesOxazolesProspective StudiesAntitubercular AgentsbedaquilineDiarylquinolinesNitroimidazolesOPC-67683Oxazolesbedaquilineculture conversiondelamanidmultidrug-resistanttuberculosis

Identifiers

PMID31712809
PMCPMC7713674

What OpenQuestion holds

Textmetadata
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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.