Evidence map›Paper›PMID 38842323›Full record

Trial reportAntimicrobial agents and chemotherapy2024

How much should we still worry about QTc prolongation in rifampicin-resistant tuberculosis? ECG findings from TB-PRACTECAL clinical trial.

Ilaria Motta, Martina Cusinato, Andrew J Ludman, Nathalie Lachenal, Matthew Dodd, Moe Soe, Tleubergen Abdrasuliev, Ruzilya Usmanova, Ilhomjon Butabekov, Tigay Zinaida Nikolaevna and 8 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02589782 (A Randomised, Controlled, Open-Label, Phase II-III Trial to Evaluate the Safety and Efficacy of Regimens Containing Bedaquiline and Pretomanid for the Treatment of Adult Patients With Pulmonary Multidrug Resistant Tuberculosis), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

NCT02589782 phase2 / phase3completednot on this map

A Randomised, Controlled, Open-Label, Phase II-III Trial to Evaluate the Safety and Efficacy of Regimens Containing Bedaquiline and Pretomanid for the Treatment of Adult Patients With Pulmonary Multidrug Resistant Tuberculosis

TypeinterventionalSponsorMedecins Sans Frontieres, NetherlandsRan2017 to 2022Enrolled552ConditionsTuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Tuberculosis, PulmonaryArmsBedaquiline, Pretomanid, Moxifloxacin, Linezolid, Clofazimine
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. 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

18 authors.

Ilaria Motta *Médecins Sans Frontières, London, United Kingdom.ORCID 0000-0002-3283-3192
Martina Cusinato *Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.ORCID 0000-0002-5371-2314
Andrew J LudmanRoyal Devon University Healthcare NHS Foundation Trust, Exeter, United Kingdom.ORCID 0000-0001-8000-4295
Nathalie LachenalMédecins Sans Frontières, Geneva, Switzerland.
Matthew DoddDepartment of Medical Statistics, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.ORCID 0000-0002-6207-6604
Moe SoeMédecins Sans Frontières, Amsterdam, the Netherlands.ORCID 0000-0002-2527-592X
Tleubergen AbdrasulievRepublican Phthisiological Hospital, Nukus, Karakalpakstan, Uzbekistan.
Ruzilya UsmanovaRepublican Specialized Scientific and Practical Medical Center of Phthisiology and Pulmonology, Tashkent, Uzbekistan.
Ilhomjon ButabekovRepublican Specialized Scientific and Practical Medical Center of Phthisiology and Pulmonology, Tashkent, Uzbekistan.ORCID 0009-0005-9498-1085
Tigay Zinaida NikolaevnaRepublican Phthisiological Hospital 2, Nukus, Karakalpakstan, Uzbekistan.
Irina LiverkoRepublican Specialized Scientific and Practical Medical Center of Phthisiology and Pulmonology, Tashkent, Uzbekistan.
Nargiza ParpievaRepublican Specialized Scientific and Practical Medical Center of Phthisiology and Pulmonology, Tashkent, Uzbekistan.
Ronelle MoodliarTHINK (TB&HIV Investigative Network): Doris Goodwin Hospital, Pietermaritzburg and Hillcrest, Durban, South Africa.
Varvara SolodovnikovaRepublican Research and Practical Centre for Pulmonology and TB, Minsk, Belarus.
Emil KazounisMédecins Sans Frontières, London, United Kingdom.
Bern-Thomas Nyang'waMédecins Sans Frontières, London, United Kingdom.
Katherine L FieldingDepartment of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.ORCID 0000-0002-6524-3754
Catherine BerryMédecins Sans Frontières, London, United Kingdom.

Funding

Médecins Sans Frontières (MSF)
6 · The paper itself

Abstract

Regimens for the treatment of rifampicin-resistant tuberculosis currently rely on the use of QT-prolonging agents. Using data from the randomized controlled trial, TB-PRACTECAL, we investigated differences in QTcF among participants in the three interventional arms: BPaL (bedaquiline, pretomanid, and linezolid), BPaLC (BPaL with clofazimine), and BPaLM (BPaL with moxifloxacin). Additionally, we assessed whether age, body mass index, and country were causally associated with QTcF prolongation. The trial included participants from South Africa, Uzbekistan, and Belarus. A CLINICAL TRIALS: This study is registered with ClinicalTrials.gov as NCT02589782.

Indexed as

Antitubercular AgentsElectrocardiographyLong QT SyndromeMoxifloxacinRifampinAdultClofazimineDiarylquinolinesFemaleHumansMaleMiddle AgedRepublic of BelarusSouth AfricaTuberculosis, Multidrug-ResistantAntitubercular AgentsbedaquilineClofazimineDiarylquinolinesMoxifloxacinRifampinbedaquilineBPaL/McardiotoxicityDR-TBdrug-resistant tuberculosis

Identifiers

PMID38842323
PMCPMC11232376

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.