LeprosyINDIGO#2NCT06222372
Novel Interventions and Diagnostic Tests for Leprosy
A study testing Rifampin in people with Leprosy, run by Annemieke Geluk at 1 site in Bangladesh.
Trial summary
Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leprosy
- What is being tested?
- Rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteBangladesh
- Study dates
- 4 Mar 2020to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- newly diagnosed multibacillary leprosy patients (BI 1-6)
- living in the same house (household members)
- living in a house on the same compound
- sharing the same kitchen
- direct neighbors (first neighbors)
- willing to participate
- provide informed consent
Who cannot join
- refusal of examination of their contacts
- suffering from the pure neural form of leprosy
- residing only temporarily in the study area
- PB leprosy patients
- diagnosed as leprosy patients during contact examination
- living less than 100 m away from a patient already included in the study
Show all 13Show fewer
- first and second degree relatives of a patient already included in the study
- refusal informed consent
- pregnancy
- tuberculosis or leprosy treatment
- below 5 years of age
- known to suffer from liver disease or jaundice
- residing temporarily in the study area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
The Leprosy Mission International - Bangladesh
Nilphamari, 5300
Abu Sufian Chowdhury, MD, +88 (0) 1713 362 720, dr.sufian@tlmbangladesh.org
About this study
Official title: Monitoring the Effect of Prophylactic Interventions in Contacts of Leprosy Patients Including Field-application of a Novel Immunodiagnostic Test in Bangladesh
Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent leprosy. In a previous field trial the BCG vaccine was applied alone and combined with a single dose of rifampin (SDR) as prophylactic interventions in contacts of leprosy patients in Bangladesh. Concurrently, blood-derived host immune-profiles specific for M. leprae infection or leprosy disease were assessed in the same population by merging detection of innate, adaptive cellular as well as humoral immunity. This has led to the identification of selected host-immune markers, currently applied in a low complexity lateral flow assay based on up-coverting particles (UCP-LFA), providing a convenient tool to assess M. leprae infection, allowing assessment of efficacy of prophylactic interventions in a point-of-care setting.
The proposed study aims to determine the effect of post-exposure prophylaxis by SDR on M. leprae infection rate using UCP-LFA before and after prophylaxis.
Read the detailed description
A stable leprosy new case detection rate in many endemic countries indicates that the transmission of M. leprae is continuing unabated and that the current control strategy of case finding and provision of multi drug therapy (MDT) is not sufficient. Immunoprophylaxis by vaccination or post-exposure prophylaxis (PEP) with antibiotics provide effective strategies for the prevention of leprosy. Prophylactic treatment with single dose rifampicin (SDR) has shown to be a successful method to prevent leprosy in contacts of newly diagnosed leprosy patients (1). Currently, the Leprosy Post-Exposure Prophylaxis (LPEP) program generates evidence on the feasibility of integrating contact tracing and single-dose rifampicin (SDR) administration into routine leprosy control activities within the national leprosy control programmes of Brazil, Cambodia, India, Indonesia, Myanmar, Nepal, Sri Lanka and Tanzania [Steinmann P, et al]. Recently, the world health orginazation (WHO) has endorsed PEP for routine application in their new "Guidelines for the diagnosis, treatment and prevention of leprosy".
Genomic and transcriptomics analysis (e.g. population- and twin studies [5]), have determined that the host genetic background is an important risk factor for leprosy susceptibility. In addition, close contacts of leprosy patients have a higher risk of developing the disease (2, 3), which therefore represents the primary target group for interventions (4). To target individuals spreading leprosy bacilli for prophylactic treatment, M. leprae infection needs to be measurable objectively. Antibody levels correspond with bacterial load and risk of transmission. Also, individuals seropositive for anti-M. leprae phenolic glycolipid-I (PGL-I) antibodies, are at 5-8 fold higher risk of leprosy (5, 6). Moreover, in a leprosy endemic area in Bangladesh, we recently showed significant added value of cellular markers (cytokines, chemokines, acute phase proteins) to identify infection (7). Thus, for implementation in a PEP-approach, new tests that indicate who needs treatment should allow detection of both cellular-and humoral markers.
In previous studies applying UCP-LFA in 4 countries with variable leprosy endemicity (Bangladesh, Brazil, China and Ethiopia), we have shown that the combined assessment of serum levels of multiple biomarkers including anti-PGL-I Ab as well as cytokines, significantly improved the diagnostic potential for detection of M. leprae infected individuals. This demonstrates that UCP-LFAs for detection of multiple biomarkers can provide valuable tools for more accurate detection of M. leprae infection. Its low-complexity POC format and applicability for use of finger-stick blood allows large scale screening efforts in field settings. Moreover, the format of the UCP-LFA is being further developed in various other projects (focused on tuberculosis and leprosy diagnostic tests). This has recently resulted in a multi-biomarker test (MBT) format that allows simultaneous detection of up to 6 markers, which is currently further evaluated in the field for tuberculosis diagnostic purposes. Since the UCP-LFA format is flexible and can accommodate for detection of different markers, this latest development will also enable combined detection of humoral and cellular biomarkers which together represent a specific signature for M. leprae infection.
- Conditions
- Leprosy
- Being tested
- Rifampin
- Keywords
- leprosy, diagnostics, SDR, post exposure prophylaxis (PEP), biomarkers, UCP-LFA
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampinDrug
antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Single dose rifampin (SDR) | Experimental | To household contacts of newly diagnosed leprosy patients SDR is provided as follows: 600 mg rifampicin for adults weighing 35 kg and over, 450 mg for adults weighing less than 35 kg and for children older than 9 years, and 300 mg for children aged 5 to 9 years. Receives: Drug: Rifampin |
| Single double dose rifampin (SDDR) | Experimental | To household contacts of newly diagnosed leprosy patients SDDR is provided as follows: 1200 mg rifampicin for adults weighing 35 kg and over, 900 mg for adults weighing less than 35 kg and for children older than 9 years, and 600 mg for children aged 5 to 9 years. Receives: Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of levels of host serum proteins in contacts after SDR
Using UCP-LFA levels of biomarkers will be quantified in fingerprick blood samples
Measured: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR
Changes of levels of host serum proteins in contacts after SDDR
Using UCP-LFA levels of biomarkers will be quantified in fingerprick blood samples
Measured: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDDR
Secondary outcomes (2)
Changes in bacterial load in contacts after SDR
determining M.leprae DNA in nasal swabs
Measured: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR
Changes in bacterial load in contacts after SDDR
determining M.leprae DNA in nasal swabs
Measured: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDDR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start4 Mar 2020
- Primary completion1 Jun 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Contacts of new MB leprosy patients with a bacterial index (BI) of 2 or more will be included. To determine the effect of SDR on M. leprae infection rate using UCP-LFA prospectively, SDR will be administered to 10 contacts of the new leprosy patients (n=100). M. leprae infection will be determined for each patient and contact by finger stick UCP-LFA for multiplex detection of anti-M. leprae antibodies and cytokines at time points 0 (intake), 2 weeks, 4 weeks, and 6 months after SDR (n=4,400). Contacts will include both household and neighbor contacts.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annemieke Geluk
- Sponsor type
- University, hospital or other
- Collaborators
- The Leprosy Mission Bangladesh
- Responsible party
- Sponsor-investigator, Annemieke Geluk, Leiden University Medical Center
- Investigators
- Annemieke Geluk, PhD, Principal investigator, Academisch Ziekenhuis Leiden (LUMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222372
- Sponsor's protocol ID
- INDIGO#2
- Acronym
- INDIGO#2
- Status last verified
- Sep 2025
- First submitted
- 3 Jan 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Effect of Prophylactic Interventions in Contacts of Leprosy Patients Including Field-application of a Novel Immunodiagnostic Test in Bangladesh
- ClinicalTrials.gov ID
- NCT06222372
- Acronym / sponsor ID
- INDIGO#2 / INDIGO#2
- Conditions
- Leprosy
- Keywords
- leprosy, diagnostics, SDR, post exposure prophylaxis (PEP), biomarkers, UCP-LFA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Annemieke GelukUniversity, hospital or other
- Collaborators
- The Leprosy Mission Bangladesh
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent leprosy. In a previous field trial the BCG vaccine was applied alone and combined with a single dose of rifampin (SDR) as prophylactic interventions in contacts of leprosy patients in Bangladesh. Concurrently, blood-derived host immune-profiles specific for M. leprae infection or leprosy disease were assessed in the same population by merging detection of innate, adaptive cellular as well as humoral immunity. This has led to the identification of selected host-immune markers, currently applied in a low complexity lateral flow assay based on up-coverting particles (UCP-LFA), providing a convenient tool to assess M. leprae infection, allowing assessment of efficacy of prophylactic interventions in a point-of-care setting.
The proposed study aims to determine the effect of post-exposure prophylaxis by SDR on M. leprae infection rate using UCP-LFA before and after prophylaxis.
Detailed description
A stable leprosy new case detection rate in many endemic countries indicates that the transmission of M. leprae is continuing unabated and that the current control strategy of case finding and provision of multi drug therapy (MDT) is not sufficient. Immunoprophylaxis by vaccination or post-exposure prophylaxis (PEP) with antibiotics provide effective strategies for the prevention of leprosy. Prophylactic treatment with single dose rifampicin (SDR) has shown to be a successful method to prevent leprosy in contacts of newly diagnosed leprosy patients (1). Currently, the Leprosy Post-Exposure Prophylaxis (LPEP) program generates evidence on the feasibility of integrating contact tracing and single-dose rifampicin (SDR) administration into routine leprosy control activities within the national leprosy control programmes of Brazil, Cambodia, India, Indonesia, Myanmar, Nepal, Sri Lanka and Tanzania [Steinmann P, et al]. Recently, the world health orginazation (WHO) has endorsed PEP for routine application in their new "Guidelines for the diagnosis, treatment and prevention of leprosy".
Genomic and transcriptomics analysis (e.g. population- and twin studies [5]), have determined that the host genetic background is an important risk factor for leprosy susceptibility. In addition, close contacts of leprosy patients have a higher risk of developing the disease (2, 3), which therefore represents the primary target group for interventions (4). To target individuals spreading leprosy bacilli for prophylactic treatment, M. leprae infection needs to be measurable objectively. Antibody levels correspond with bacterial load and risk of transmission. Also, individuals seropositive for anti-M. leprae phenolic glycolipid-I (PGL-I) antibodies, are at 5-8 fold higher risk of leprosy (5, 6). Moreover, in a leprosy endemic area in Bangladesh, we recently showed significant added value of cellular markers (cytokines, chemokines, acute phase proteins) to identify infection (7). Thus, for implementation in a PEP-approach, new tests that indicate who needs treatment should allow detection of both cellular-and humoral markers.
In previous studies applying UCP-LFA in 4 countries with variable leprosy endemicity (Bangladesh, Brazil, China and Ethiopia), we have shown that the combined assessment of serum levels of multiple biomarkers including anti-PGL-I Ab as well as cytokines, significantly improved the diagnostic potential for detection of M. leprae infected individuals. This demonstrates that UCP-LFAs for detection of multiple biomarkers can provide valuable tools for more accurate detection of M. leprae infection. Its low-complexity POC format and applicability for use of finger-stick blood allows large scale screening efforts in field settings. Moreover, the format of the UCP-LFA is being further developed in various other projects (focused on tuberculosis and leprosy diagnostic tests). This has recently resulted in a multi-biomarker test (MBT) format that allows simultaneous detection of up to 6 markers, which is currently further evaluated in the field for tuberculosis diagnostic purposes. Since the UCP-LFA format is flexible and can accommodate for detection of different markers, this latest development will also enable combined detection of humoral and cellular biomarkers which together represent a specific signature for M. leprae infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Contacts of new MB leprosy patients with a bacterial index (BI) of 2 or more will be included. To determine the effect of SDR on M. leprae infection rate using UCP-LFA prospectively, SDR will be administered to 10 contacts of the new leprosy patients (n=100). M. leprae infection will be determined for each patient and contact by finger stick UCP-LFA for multiplex detection of anti-M. leprae antibodies and cytokines at time points 0 (intake), 2 weeks, 4 weeks, and 6 months after SDR (n=4,400). Contacts will include both household and neighbor contacts.
| Arm | Type | Receives |
|---|---|---|
| Single dose rifampin (SDR) | Experimental | Drug: RifampinTo household contacts of newly diagnosed leprosy patients SDR is provided as follows: 600 mg rifampicin for adults weighing 35 kg and over, 450 mg for adults weighing less than 35 kg and for children older than 9 years, and 300 mg for children aged 5 to 9 years. |
| Single double dose rifampin (SDDR) | Experimental | Drug: RifampinTo household contacts of newly diagnosed leprosy patients SDDR is provided as follows: 1200 mg rifampicin for adults weighing 35 kg and over, 900 mg for adults weighing less than 35 kg and for children older than 9 years, and 600 mg for children aged 5 to 9 years. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- newly diagnosed multibacillary leprosy patients (BI 1-6)
- living in the same house (household members)
- living in a house on the same compound
- sharing the same kitchen
- direct neighbors (first neighbors)
Key exclusion criteria (13 listed)
- refusal of examination of their contacts
- suffering from the pure neural form of leprosy
- residing only temporarily in the study area
- PB leprosy patients
- diagnosed as leprosy patients during contact examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifampinantibiotic | Drug | Single dose rifampin (SDR), Single double dose rifampin (SDDR) |
Primary outcome
Changes of levels of host serum proteins in contacts after SDR
Time frame: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR
Using UCP-LFA levels of biomarkers will be quantified in fingerprick blood samples
Changes of levels of host serum proteins in contacts after SDDR
Time frame: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDDR
Using UCP-LFA levels of biomarkers will be quantified in fingerprick blood samples
2 secondary outcomes
Changes in bacterial load in contacts after SDR
Time frame: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR
Changes in bacterial load in contacts after SDDR
Time frame: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDDR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annemieke Geluk, PhD principal investigator
Academisch Ziekenhuis Leiden (LUMC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifampin in people with Leprosy, run by Annemieke Geluk at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemieke Geluk, PhD (+31715261974, ageluk@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of levels of host serum proteins in contacts after SDR (time frame: samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.