Evidence map›Paper›PMID 40381662›Full record

Trial reportThe Journal of infection2025

Long term outcomes in drug resistant tuberculosis with Bedaquiline, Pretomanid and varying doses of Linezolid.

Bella Devaleenal Daniel, Sivakumar Shanmugam, Rashi Mehta, Manpreet Bhalla, Muthuvijayalakshmi Mariappan, Balaji Ramraj, Avijit Kumar Awasthi, Pranav Patel, Amita Jain, Parul Jain and 22 more

Abstract readRandomized Controlled TrialMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in The Journal of infection, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. 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

32 authors.

Bella Devaleenal DanielICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India. Electronic address: belladevalleenal.d@icmr.gov.in.
Sivakumar ShanmugamICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
Rashi MehtaInfexn laboratories Private Ltd, Mumbai, Maharashtra, India.
Manpreet BhallaNational Institute of Tuberculosis and Respiratory Diseases, New Delhi, India.
Muthuvijayalakshmi MariappanICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
Balaji RamrajICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India. Electronic address: balaji.ramraj@icmr.gov.in.
Avijit Kumar AwasthiIntermediate Reference Laboratory, NTEP, State TB Training & Demonstration Centre, Agra, Uttar Pradesh, India.
Pranav PatelIntermediate Reference Laboratory, NTEP, Ahmedabad, Gujarat, India.
Amita JainKing George's Medical University, Lucknow, Uttar Pradesh, India.
Parul JainKing George's Medical University, Lucknow, Uttar Pradesh, India.
Chetan KumarSarvodaya Charitable Trust Hospital, Mumbai, Maharashtra, India.
Vikas OswalShatabdi Centenary Hospital, Mumbai, Maharashtra, India.
Neeta SinglaNational Institute of Tuberculosis and Respiratory Diseases, New Delhi, India.
Santosh KumarSN Medical College, Agra, Uttar Pradesh, India.
Jigna DaveGovernment Medical College, Bhavnagar, Gujarat, India.
Parul VadgamaGovernment Medical College, Surat, Gujarat, India.
Anuj K BhatnagarRajan Babu Institute of Pulmonary Medicine and Tuberculosis, New Delhi, India.
Surya KantKing George's Medical University, Lucknow, Uttar Pradesh, India.
Rathinam PrabhakaranGovernment Rajaji Hospital, Madurai Medical College, Madurai, Tamil Nadu, India.
Grinish TamakuwalaGovernment Medical College, Surat, Gujarat, India.
Rishikesh Nath MukherjeeRajan Babu Institute of Pulmonary Medicine and Tuberculosis, New Delhi, India.
Ramesh Kumar SanthanakrishnanICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
Dhandapani RavikumarICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
Naveen Kumar NagarajanICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
Shanmugapriya KumaravadiveluICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
Jeyadeepa BharathiICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
Anand SridharWorld Health Organization, India Office, New Delhi, India.
Ranjani RamachandranWorld Health Organization, India Office, New Delhi, India.
Sanjay K MatooNational Tuberculosis Elimination Programme, Central TB Division, New Delhi, India.
Chinnaiyan PonnurajaICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
Jyoti JajuiDEFEAT TB project, International Union Against Tuberculosis and Lung Disease, New Delhi, India.
Chandrasekaran PadmapriyadarsiniICMR - National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.

Funding

World Health Organization 001
6 · The paper itself

Abstract

objectivesAssess the effectiveness of bedaquiline, pretomanid and linezolid (BPaL) regimens with varying doses and duration of linezolid at the end of 48 weeks post treatment among drug resistant tuberculosis (DR TB) patients.

methodsMulticentric pragmatic randomized clinical trial in which BPaL regimens were given for 26 weeks for pulmonary pre extensively drug resistant tuberculosis (PreXDR TB); bedaquiline, pretomanid and linezolid 600 mg for 26 weeks (arm1), structured dose reduction arms with linezolid dose reduction from 600 to 300 mg after nine weeks (arm2) and 13 weeks (arm3). Participants were followed up for recurrence-free cure up to 48 weeks post-treatment. Whole genome sequencing in sputum samples at baseline and recurrence differentiated relapse and reinfection.

resultsOf 403 enrolled, 378 were included for the modified intent-to-treat analysis based on baseline sputum culture positivity and sensitivity to medications in the study regimen. Among them, 331(88%) had recurrence-free cure at the end of 48 weeks of post-treatment follow-up; arm1:112(87%), arm2:110(88%), arm3:109(88%). Overall, 14 (12 bacteriological and 2 clinical) recurrences (arm1-four, 2-six and 3-four) occurred; 11 recurrences occurred within 24 weeks after treatment completion; four out of 11 within the first 12 weeks. Of the 10 paired sputum samples available at baseline and recurrence for comparison of lineages, there were two reinfections and eight relapses.

conclusionStructured dose reduction arms had comparable recurrence free cure rates as linezolid 600 mg arm when given along with bedaquiline and pretomanid for 26 weeks in PreXDR TB. Most of the recurrences occurred within the first six months.

Indexed as

Antitubercular AgentsDiarylquinolinesLinezolidNitroimidazolesTuberculosis, Multidrug-ResistantAdultFemaleHumansIntention to Treat AnalysisMaleMiddle AgedMycobacterium tuberculosisRecurrenceSputumTreatment OutcomeYoung AdultAntitubercular AgentsbedaquilineDiarylquinolinesLinezolidNitroimidazolespretomanidBedaquilineDose reductionDrug resistant tuberculosisIndiaLinezolidPretomanidRecurrenceTreatment outcome

Identifiers

PMID40381662
PMCPMC12170348

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.