Evidence map›Paper›PMID 41699691›Full record

ArticleTrials2026

Protocol of a comparative multicentric non inferiority clinical trial of WHO MBMDT with a new monthly chemotherapy regimen containing rifampicin, moxifloxacin and clarithromycin (RMC) on multibacillary patients from India.

Joydeepa Darlong, Samrun Nessa, Itu Singh, Utpal Sengupta, Reeta Devi, Kartikeyan Govindasamy, Neeta Maximus, Vandana Elkana, Anamika Haldar, Ann Miriam Jose and 1 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

11 authors.

Joydeepa DarlongThe Leprosy Mission Trust India (TLMTI), New Delhi, India. joydeepa.darlong@leprosymission.in.ORCID http://orcid.org/0000-0002-3242-8875
Samrun NessaThe Leprosy Mission Trust India (TLMTI), New Delhi, India.
Itu SinghThe Leprosy Mission Trust India (TLMTI), New Delhi, India.
Utpal SenguptaThe Leprosy Mission Trust India (TLMTI), New Delhi, India.
Reeta DeviThe Leprosy Mission Trust India (TLMTI), New Delhi, India.
Kartikeyan GovindasamyThe Leprosy Mission Trust India (TLMTI), New Delhi, India.
Neeta MaximusThe Leprosy Mission Trust India (TLMTI), New Delhi, India.
Vandana ElkanaThe Leprosy Mission Trust India (TLMTI), New Delhi, India.
Anamika HaldarThe Leprosy Mission Trust India (TLMTI), New Delhi, India.
Ann Miriam JoseSchieffelin Institute of Health - Research & Leprosy Centre (SIH-R & LC), Vellore, India.
Sylvia JayakumarSTATSHUB, Statistical Consulting Services, Chennai, Tamil Nadu, India.

Funding

Indian Council of Medical Research DDR/IIRP23/4691
6 · The paper itself

Abstract

backgroundCurrent WHO MBMDT regimen has largely been successful in treating leprosy patients since 1984, when it was implemented worldwide. According to clinical presentation, pauci and multibacillary leprosy, the regimen is also given for 6 or 12 months. However, this regimen has its limitations, such as incomplete bacterial clearance, prolonged treatment duration and poor patient compliance, necessitating administration of alternative and more effective regimens. Secondly, there is a subset of patients who are highly bacillated and continue to harbour viable bacilli even after treatment and thus continue transmission. We present the protocol of WHOMDT vs. monthly regimen of rifampicin, moxifloxacin and clarithromycin (RMC), a randomised clinical trial designed to test the efficacy of the RMC regimen in the management of multibacillary leprosy. METHODS AND ANALYSIS: MB MDT vs RMC clinical trial is multicentric which will be conducted in accordance with the CONSORT guidelines in The Leprosy Mission Trust India's tertiary care hospitals at Delhi, Uttar Pradesh, West Bengal and Chhattisgarh. Naive MB leprosy patients who consent to participate will be randomly allocated to receive 12 months of WHO MB MDT or a monthly regimen of rifampicin, moxifloxacin and clarithromycin. The primary objective will be to evaluate the efficacy of monthly RMC regimen compared to the WHOMBMDT in treating multibacillary leprosy. Molecular viability assay will be used to assess the efficacy of the regimen. Monitoring of adverse events will be closely done. ETHICS AND DISSEMINATION: Results will be submitted for publication in peer-reviewed journals. Ethical approval has been obtained from The Leprosy Mission Trust India's ethics committee (TLMTI/EC/C-69). This study is registered at Clinical Trials Registry-India (CTRI) - CTRI/2024/03/064435.

Indexed as

ClarithromycinLeprostatic AgentsLeprosy, MultibacillaryMoxifloxacinMycobacterium lepraeRifampinAdolescentAdultDrug Administration ScheduleDrug Therapy, CombinationEquivalence Trials as TopicFemaleHumansIndiaMaleMulticenter Studies as TopicClarithromycinLeprostatic AgentsMoxifloxacinRifampinClarithromycinClinical trialMolecular viability assayMouse footpad testMoxifloxacinMultibacillary leprosyRifampicinWHO MBMDT

Identifiers

PMID41699691
PMCPMC13020299

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.