Clinical trial of WHO multibacillary multidrug therapy versus rifampicin, moxifloxacin and clarithromycin on multibacillary leprosy patients from India
| ISRCTN | ISRCTN70846313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70846313 |
| Secondary identifying numbers | CTRI/2024/03/064435 |
- Submission date
- 27/06/2024
- Registration date
- 08/07/2024
- Last edited
- 19/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
This clinical trial focuses on evaluating the effectiveness and safety of a new treatment for leprosy. Leprosy is a chronic infectious disease caused by the bacterium Mycobacterium leprae. The study aims to determine if the new treatment can reduce the bacterial load, achieve a complete clinical cure, and improve pathological (disease) markers in patients with leprosy.
Who can participate?
Patients aged 15-60 years with multibacillary leprosy who have not received treatment
What does the study involve?
Participants will receive the new treatment and undergo various assessments, including tests measuring bacterial load, clinical examinations to assess lesion regression and overall improvement, and tests to evaluate changes in the Bacillary Index (BI). These assessments will occur at the start of the study and after 3 months, 6 months, and 1 year.
What are the possible benefits and risks of participating?
Benefits:
1. Participants may experience improvement in their leprosy symptoms.
2. Contribution to scientific knowledge that may help future patients with leprosy.
Risks:
1. Possible side effects of the treatment, ranging from mild to severe.
2. Regular follow-up visits and tests may be time-consuming.
Where is the study run from?
The Leprosy Mission Trust India
When is the study starting and how long is it expected to run for?
March 2023 to July 2025
Who is funding the study?
Indian Council of Medical Research
Who is the main contact?
Dr Joydeepa Darlong, joydeepa.darlong@leprosymission.in
Contact information
Principal Investigator
16, Pandit Pant Marg
CNI Bhavan
New Delhi
110001
India
 ORCID ID |
0000-0002-3242-8875 |
|---|---|
| Phone | +91 (0)9434885198 |
| joydeepa.darlong@leprosymission.in |
Scientific
Stanley Browne Laboratory
TLM Community Hospital Shahdara
Delhi
110093
India
| ORCID ID |
0000-0003-0596-8566 |
|---|---|
| Phone | +91 (0)9717730549 |
| itu.singh@leprosymission.in |
Public
TLM Community Hospital Shahdara
Nand Nagari
Delhi
110093
India
| ORCID ID |
0000-0002-4107-4271 |
|---|---|
| Phone | +91 (0)6006203600 |
| reeta.devi@leprosymission.in |
Public
TLM Community Hospital Shahdara
Delhi
110093
India
| Phone | +91 (0)9110322091 |
|---|---|
| samrun.nessa@leprosymission.in |
Public
TLM Hospital Barabanki
Barabanki
225001
India
| Phone | +91 (0)9936566849 |
|---|---|
| neeta.maximus@leprosymission.in |
Public
TLM Chandkhuri
Bilaspur
495222
India
| Phone | +91 (0)9981774449 |
|---|---|
| vandana.elkana@leprosymission.in |
Scientific
Stanley Browne Laboratory
TLM Community Hospital Shahdara
Delhi
110093
India
| ORCID ID |
0000-0002-1177-1076 |
|---|---|
| Phone | +91 (0)9212761651 |
| utpal.sengupta@leprosymission.in |
Scientific
16, Pandit Pant Marg
CNI bhavan
New Delhi
100001
India
| ORCID ID |
0000-0001-5500-1308 |
|---|---|
| Phone | +91 (0)9935284315 |
| karthikeyan.g@leprosymission.in |
Scientific
The Leprosy Mission Home and Hospital
Purulia, West Bengal
723101
India
| Phone | +91 (0)8271855993 |
|---|---|
| anamika.haldar@leprosymission.in |
Scientific
Molecular Biology Lab
Schieffelin Institute of Health – Research & Leprosy Centre (SIH-R & LC)
Vellore
632106
India
| annmjose97@gmail.com |
Study information
| Study design | Open-label randomized clinical control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 45703_PIS.pdf |
| Scientific title | A comparative multicentric non-inferiority clinical trial of WHO multibacillary multidrug therapy with a new monthly chemotherapy regimen containing rifampicin, moxifloxacin and clarithromycin on multibacillary patients from India |
| Study acronym | RMC |
| Study objectives | Monthly rifampicin, moxifloxacin and clarithromycin (RMC) are as efficacious and safe as WHO multibacillary multidrug therapy (MBMDT) in patients affected by multibacillary leprosy. |
| Ethics approval(s) |
Approved 20/11/2023, TLMTI ethics Committee (16, Pandit Pant Marg, CNI Bhawan, New Delhi, 110001, India; +91 (0)9811912926; monicathomaschandy@gmail.com), ref: TLMTI/EC/C- 68 |
| Health condition(s) or problem(s) studied | Leprosy |
| Intervention | It is an open-label randomized clinical control non-inferiority trial where in the intervention group a monthly supervised regimen of rifampicin, moxifloxacin and clarithromycin will be administered in doses of 600 mg, 400 mg, and 1000 mg respectively once a month and the control arm would be given routine WHO MB MDT (rifampicin 600 mg, clofazimine 300 mg once monthly and clofazimine 50 and dapsone 100 mg daily). The duration of the treatment in both arms will be 12 months. The random sequence will be generated centrally which will be sent to study centers in opaque envelopes. After consent is approved, the envelope will be opened, and the patient will be put on the respective arms. The study population will include newly diagnosed, previously untreated MB leprosy patients. Written informed consent will be sought from every subject included in the study. Slit skin smears of all the study subjects will be collected at baseline, 6 and 12 months and transported in RNA later to the SBL. Real-time PCR will be done to quantitate copy numbers of the genes encoding 16S rRNA, hsp18 and exsA specific for M. leprae. Resistance studies will be carried out at 12 months in patients harbouring viable bacilli. Validation of M. leprae growth in mouse foot pad will be performed on participants showing viable load by molecular methods at the time of RFT in Schieffelin Institute of Health – Research and Leprosy Centre Karigiri (SIHR&LC), Vellore. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Rifampicin, moxifloxacin, clarithromycin, clofazimine, dapsone |
| Primary outcome measure | 1. Molecular: 1.1. Reduction of copy numbers by molecular viability assay (MVA) measured using quantitative PCR (qPCR) at baseline, 1, 3, 6 and 12 months 1.2. Complete killing of M. leprae assessed using mouse foot pad (MFP) assay at release from treatment (RFT) (12 months) 2. Clinical: 2.1. Complete clinical cure, defined as full regression of the lesions, assessed through clinical examination at baseline, 6 months, and 1 year 2.2. Clinical improvement of the lesions measured by a clinical criterion (e.g., lesion size reduction) at baseline, 6 months, and 1 year 3. Pathological: 3.1. Bacillary Index (BI) improvement measured using skin smears and histopathological examination at baseline, 3 months, 6 months, and 1 year |
| Secondary outcome measures | 1. Immunological outcomes: 1.1. Neuritis measured through patient self-reporting of pain during interviews and nerve function tests (e.g., sensory and motor function tests) every month during the treatment period and thereafter 6 monthly for 1 year 1.2. Type I reaction assessed through clinical examination and patient reporting with type 1 reaction from the development of the reaction to its subsidence 1.3. Type II reaction assessed through clinical examination and patient reporting with type 2 reaction from the development of the reaction to its subsidence 2. Safety outcomes: 2.1. Severe side effects, defined as side effects that force the patient to stop treatment, monitored and recorded throughout the treatment period (baseline to 1 year) 2.2. Mild to moderate side effects monitored and recorded throughout the treatment period (baseline to 1 year) 3. Qualitative outcomes: 3.1. Impact of leprosy treatment on life assessed using patient interviews and quality of life questionnaires at 1 year 3.2. Perspective towards leprosy treatment assessed using patient interviews and attitude questionnaires at 1 year |
| Overall study start date | 21/03/2023 |
| Completion date | 14/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 280 |
| Key inclusion criteria | 1. Age 15 years and above 2. Multibacillary (MB) leprosy, defined as 5 or more skin lesions or extensive infiltration and/or diffuse skin involvement, classified as borderline tuberculoid, borderline lepromatous or polar lepromatous, as determined using the Ridley and Jopling classification system 3. Never treated before for leprosy |
| Key exclusion criteria | 1. History of intolerance to one of the medications 2. Patients who are not able to come to the clinic every month during their treatment and during follow-up 3. Patients who do not give informed consent or are not capable of giving informed consent due to mental impairment 4. Immunocompromised patients diagnosed with HIV/AIDS and tuberculosis |
| Date of first enrolment | 02/07/2024 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- India
Study participating centres
Puruliya
723101
India
Barabanki
225001
India
Chandkhuri
495222
India
Delhi
110093
India
Sponsor information
Charity
16, Pandit Pant Marg
CNI Bhavan
New Delhi
110001
India
| Phone | +91 (0)1122110788 |
|---|---|
| helen.roberts@leprosymission.in | |
| Website | https://www.leprosymission.in |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Indian Council of Medical Research, Government of India, Indian Council of Medical Research (ICMR), New Delhi, ICMROrganisation, भारतीय चिकित्सा अनुसंधान परिषद, Indian Council of Medical Research, New Delhi, ICMR, ICMRDELHI, आई.सी.एम.आर
- Location
- India
Results and Publications
| Intention to publish date | 10/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/07/2024 | No | Yes | ||
| Other files | Standard operating procedure documents | 12/08/2024 | No | No | |
| Other files | 25/08/2023 | 19/08/2024 | No | No |
Additional files
- 45703_PIS.pdf
- ISRCTN70846313 SOP documents.zip
- Standard operating procedure documents
- ISRCTN70846313_Indian Council of Medical Research_Investigator-Initiated Research Proposal_25Aug2023.pdf
Editorial Notes
19/08/2024: An Indian Council of Medical Research Investigator-Initiated Research Proposal document was uploaded as an additional file.
12/08/2024: A zipped folder of standard operating procedure documents was uploaded as an additional file.
01/07/2024: Study's existence confirmed by the Indian Council of Medical Research.
