Evidence map›Paper›PMID 22391540›Full record

Trial reportAntimicrobial agents and chemotherapy2012

Randomized pilot trial of eight weeks of bedaquiline (TMC207) treatment for multidrug-resistant tuberculosis: long-term outcome, tolerability, and effect on emergence of drug resistance.

A H Diacon, P R Donald, A Pym, M Grobusch, R F Patientia, R Mahanyele, N Bantubani, R Narasimooloo, T De Marez, R van Heeswijk and 4 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02409290 (STREAM), which is not on this map. Cited by 168 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
168citing papers in PubMed, 9 pooled it
23.7field-weighted citation impact, top 1% 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.

NCT02409290 phase3completednot on this mapstarted 2016, after this paper: background citation

STREAM: The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

TypeinterventionalSponsorIUATLD, IncRan2016 to 2023Enrolled588ConditionsMDR-TBArmsRegimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Clofazimine, Ethambutol, Pyrazinamide
3 · Its place in the literature

Who cites it

168 citing papers in PubMed, 9 syntheses or guidelines pooled it, 375 citations in OpenAlex.

  1. Pooled it
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  3. Guideline
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  5. Linezolid for drug-resistant pulmonary tuberculosis.The Cochrane database of systematic reviews · 2019
    Pooled it
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  8. Fluoroquinolones for treating tuberculosis (presumed drug-sensitive).The Cochrane database of systematic reviews · 2013
    Pooled it
  9. Pooled it
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  13. Bedaquiline for multidrug-resistant TB in paediatric patients.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2021
    Trial
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108 more citing papers are in PubMed but not listed here.

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

14 authors at 3 institutions in 1 country.

A H DiaconFaculty of Health Sciences, Stellenbosch University, Tygerberg, South Africa.
P R Donald
A Pym
M Grobusch
R F Patientia
R Mahanyele
N Bantubani
R Narasimooloo
T De Marez
R van Heeswijk
N Lounis
P Meyvisch
K Andries
D F McNeeley
Stellenbosch University · ZAUniversity of the Witwatersrand · ZASouth African Medical Research Council · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The 2-year follow-up results for a randomized placebo-controlled study of 47 patients with multidrug-resistant pulmonary tuberculosis treated with either the new diarylquinoline TMC207, recently renamed bedaquiline, or placebo, added to the first 8 weeks of a background regimen, are presented. Bedaquiline significantly reduced the time to culture conversion over 24 weeks (hazard ratio, 2.253; 95% confidence interval, 1.08 to 4.71; P = 0.031). With the exception of nausea reported in 26% of patients receiving bedaquiline and none receiving placebo, adverse events occurred at similar frequencies in both groups of patients: bilateral hearing impairment, extremity pain, acne, and noncardiac chest pain occurred in 13 and 21%, 17 and 13%, 9 and 17%, and 4 and 17% of patients, respectively, receiving bedaquiline or placebo. Excluding resistance to ethambutol and ethionamide, only one patient receiving bedaquiline acquired resistance to companion drugs, but five patients receiving placebo (4.8% versus 21.7%; P = 0.18) acquired resistance to companion drugs, and resistance to ofloxacin was acquired in four patients receiving placebo and none receiving bedaquiline (0% versus 22%; 0 = 0.066). In all, 23 patients (49%), including 13 receiving placebo (54%) and 10 receiving bedaquiline (44%), discontinued the study prior to its completion, 12 during the first 24 weeks of treatment. Eight subjects were withdrawn for noncompliance or default, and seven withdrew consent, citing the rigorous program of investigations for safety and pharmacokinetic monitoring. Bedaquiline may contribute to the management of multidrug-resistant tuberculosis by effecting more rapid sputum culture negativity and by preventing acquired resistance to companion drugs.

Indexed as

Antitubercular AgentsClarithromycinCycloserineDapsoneDiarylquinolinesErythromycinFemaleHumansIsoxazolesMaleOfloxacinOxazolidinonesQuinolinesTuberculosis, Multidrug-ResistantAntitubercular AgentsbedaquilineClarithromycinCycloserineDapsoneDiarylquinolinesErythromycinIsoxazolesOfloxacinOxazolidinonesQuinolinesterizidone

Identifiers

PMID22391540
PMCPMC3370813
OpenAlexW2164918529

What OpenQuestion holds

Textmetadata
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.