Evidence map›Paper›PMID 35028659›Full record

Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Safety of Treatment Regimens Containing Bedaquiline and Delamanid in the endTB Cohort.

Catherine Hewison, Uzma Khan, Mathieu Bastard, Nathalie Lachenal, Sylvine Coutisson, Elna Osso, Saman Ahmed, Palwasha Khan, Molly F Franke, Michael L Rich and 22 more

Erratum issued 2 registry-linked trialsOpen access · bronzeAbstract 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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
10.7field-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.

NCT02754765 phase3completednot on this map

Evaluating Newly Approved Drugs for Multidrug-resistant TB (endTB): A Clinical Trial

TypeinterventionalSponsorMédecins Sans Frontières, FranceRan2016 to 2023Enrolled754ConditionsTuberculosis, Multidrug-Resistant, Infection, Bacterial, Pulmonary TuberculosesArmsBedaquiline, Delamanid, Clofazimine, Levofloxacin, Moxifloxacin
NCT03259269 completednot on this map

endTB (Expand New Drugs for TB) Observational Study: Treatment of MDR-TB With Regimens Containing Bedaquiline or Delamanid

TypeobservationalSponsorPartners in HealthRan2015 to 2019Enrolled2,804ConditionsTuberculosis, Multidrug-ResistantArmsThis is a non-intervention observational study
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

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  20. Safety and Effectiveness of 3 Novel All-Oral Shortened Regimens for Rifampicin- or Multidrug-Resistant Tuberculosis in Kazakhstan.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors at 10 institutions in 7 countries.

Catherine HewisonMedical Department, Médecins Sans Frontières, Paris, France.ORCID 0000-0002-0363-1479
Uzma KhanInteractive Research and Development Global, Singapore, Singapore.
Mathieu BastardField Epidemiology Department, Epicentre, Paris, France.
Nathalie LachenalPharmacovigilance Unit, Médecins Sans Frontières, Geneva, Switzerland.
Sylvine CoutissonPharmacovigilance Unit, Médecins Sans Frontières, Geneva, Switzerland.
Elna OssoPartners In Health, Boston, Massachusetts, USA, and Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Saman AhmedInteractive Research and Development, Karachi, Pakistan.
Palwasha KhanInteractive Research and Development Global, Singapore, Singapore.
Molly F FrankePartners In Health, Boston, Massachusetts, USA, and Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Michael L RichPartners In Health, Boston, Massachusetts, USA, and Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Francis VaraineMedical Department, Médecins Sans Frontières, Paris, France.
Nara MelikyanField Epidemiology Department, Epicentre, Paris, France.
Kwonjune J SeungPartners In Health, Boston, Massachusetts, USA, and Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Malik AdenovNational Scientific Center of Phthisiopulmonology, MOH RK (NSCP MOH RK), Almaty, Kazakhstan.
Sana AdnanIndus Health Network, Karachi, Pakistan.
Narine DanielyanMedical Department, Médecins Sans Frontières, Tbilisi, Georgia.
Shirajul IslamInteractive Research and Development, Dhaka, Bangladesh.
Aleeza JanmohamedInteractive Research and Development, Karachi, Pakistan.
Hayk KarakozianMedical Department, Médecins Sans Frontières, Bishkek, Krygystan.
Maureen Kamene KimenyeNational Tuberculosis Program, Nairobi, Kenya.
Ohanna KirakosyanMedical Department, Médecins Sans Frontières, Yerevan, Armenia.
Begimkul KholikulovMedical Department, Médecins Sans Frontières, Minsk, Belarus.
Aga KrisnandaAga Krisnanda, Interactive Research and Development, Jakarta, Indonesia.
Andargachew KumsaPartners In Health, Addis Ababa, Ethiopia.
Garmaly LeblancZanmi Lasante, Cange, Haiti.
Leonid LeccaSocios En Salud Sucursal Peru, Lima, Peru.
Mpiti NkuebePartners In Health, Maseru, Lesotho.
Shahid MamsaIndus Health Network, Karachi, Pakistan.
Shrivani PadayacheeInteractive Research and Development, Durban, South Africa.
Phone ThitMedical Department, Médecins Sans Frontières, Yangon, Myanmar.
Carole D MitnickPartners In Health, Boston, Massachusetts, USA, and Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Helena HuergaField Epidemiology Department, Epicentre, Paris, France.
Brigham and Women's Hospital · USInteractive Research and Development · PKPartners In Health · USIndus Hospital · PKMédecins Sans Frontières · FRMédecins Sans Frontières · CHEsSALUD · PEKazakh Institute of Oncology and Radiology · KZMédecins Sans Frontières · USMédecins Sans Frontières · UG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSafety of treatment for multidrug-resistant tuberculosis (MDR/RR-TB) can be an obstacle to treatment completion. Evaluate safety of longer MDR/RR-TB regimens containing bedaquiline and/or delamanid.

methodsMulticentre (16 countries), prospective, observational study reporting incidence and frequency of clinically relevant adverse events of special interest (AESIs) among patients who received MDR/RR-TB treatment containing bedaquiline and/or delamanid. The AESIs were defined a priori as important events caused by bedaquiline, delamanid, linezolid, injectables, and other commonly used drugs. Occurrence of these events was also reported by exposure to the likely causative agent.

resultsAmong 2296 patients, the most common clinically relevant AESIs were peripheral neuropathy (26.4%), electrolyte depletion (26.0%), and hearing loss (13.2%) with an incidence per 1000 person months of treatment, 1000 person-months of treatment 21.5 (95% confidence interval [CI]: 19.8-23.2), 20.7 (95% CI: 19.1-22.4), and 9.7 (95% CI: 8.6-10.8), respectively. QT interval was prolonged in 2.7% or 1.8 (95% CI: 1.4-2.3)/1000 person-months of treatment. Patients receiving injectables (N = 925) and linezolid (N = 1826) were most likely to experience events during exposure. Hearing loss, acute renal failure, or electrolyte depletion occurred in 36.8% or 72.8 (95% CI: 66.0-80.0) times/1000 person-months of injectable drug exposure. Peripheral neuropathy, optic neuritis, and/or myelosuppression occurred in 27.8% or 22.8 (95% CI: 20.9-24.8) times/1000 patient-months of linezolid exposure.

conclusionsAEs often related to linezolid and injectable drugs were more common than those frequently attributed to bedaquiline and delamanid. MDR-TB treatment monitoring and drug durations should reflect expected safety profiles of drug combinations. CLINICAL TRIALS REGISTRATION: NCT02754765.

Indexed as

NitroimidazolesTuberculosis, Multidrug-ResistantAntitubercular AgentsDiarylquinolinesElectrolytesHumansLinezolidOxazolesProspective StudiesTreatment OutcomeAntitubercular AgentsbedaquilineDiarylquinolinesElectrolytesLinezolidNitroimidazolesOPC-67683Oxazolesadverse eventslinezolidMDR-TBnew drugsQT prolongation

Identifiers

PMID35028659
PMCPMC9522425
OpenAlexW4205476487

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.