LeprosyComLepNCT03526718
Improved Understanding of Ongoing Transmission of Leprosy in the Hyperendemic Comoros (ComLep)
An observational study of Leprosy, run by Institute of Tropical Medicine, Belgium at 1 site in Comoros.
Trial summary
Despite decades of a solid leprosy control program, including active case finding and follow-up on therapeutic outcome, the Comoros islands of Anjouan and Moheli continue to be hyperendemic for leprosy, with leprosy case notifications far exceeding those for tuberculosis, while the third island, Grande Comore… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leprosy
- How many people
- 889 participants
- Where
- 1 siteComoros
- Study dates
- 1 Apr 2017to 31 Dec 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Comoros islands, located between Madagascar and Mozambique, continue to be hyperendemic for leprosy. Periodic active case finding across the entire island of Anjouan is in place, resulting in early case detection, and every patient identified is being treated with highly effective multi drug therapy. Nevertheless, the high proportion of leprosy in children (31% were <15y old in 2015) in combination with a low relapse rate (<2%) indicate transmission continues unabated. The majority of the patients in Anjouan are paucibacillary.
Who may be able to join
- in the prospective cohort study: All newly diagnosed leprosy patients (any age) on the island of Anjouan who provide written informed consent.
- In the in-depth interviews: Patients who are part of a cluster and provide written informed consent. Additional written informed consent will be asked for questions in which the identity of other member(s) of a cluster needs to be revealed.
Who cannot join
- in the prospective cohort study: None.
- In the in-depth interviews: Patients belonging to clusters not extending beyond the same first or second circle
Trial locations and contacts
1 site in 1 country.
Comoros1 site
Damien Foundation
Moutsamoudou, Anjouan
About this study
Official title: Improved Understanding of Ongoing Transmission of Leprosy in the Comoros, a Region Hyperendemic for the Disease.
Despite decades of a solid leprosy control program, including active case finding and follow-up on therapeutic outcome, the Comoros islands of Anjouan and Moheli continue to be hyperendemic for leprosy, with leprosy case notifications far exceeding those for tuberculosis, while the third island, Grande Comore, presents few cases. The high proportion (31% in 2015) of disease in children indicates that recent transmission is a major driver of the persistent endemicity, and that present control measures are not sufficient. The low proportion (2.6% average in last 10 years) of grade II disabilities in newly diagnosed cases indicates that case detection is early.
The main objective of the present proposal is to identify which persons would most benefit from prophylactic treatment. The secondary objective is to unravel human, bacterial and environmental risk factors for transmission of and progression to leprosy disease, with the ultimate goal to reduce the leprosy incidence.. The program has remaining expertise to re-establish laboratory confirmation of leprosy patients, allowing to optimize and validate molecular genotyping techniques to complement conventional epidemiological investigations in a 3-year prospective cohort of leprosy patients and their close contacts, aiming to identify transmission links. A third objective is to document diagnostic delays in more detail
Read more
As the leprosy control programme has initiated a pilot study on rifampicin prophylaxis in four villages on Anjouan in 2015, a prospective cohort study will permit measuring the leprosy incidence in close contacts as well as those in neighboring houses, who did or did not receive rifampicin prophylaxis.
The expected outcome of this project will be to identify risk factors for leprosy transmission. Specifically, we expect to identify those contacts at highest risk of developing leprosy disease, who would most benefit from rifampicin prophylaxis or other preventive measures.
- Conditions
- Leprosy
- Keywords
- Transmission, Genotyping, Risk factors
- Medical subject headings
- Leprosy
What is being measured
The primary outcome is the main question the study is designed to answer.
Leprosy incidence among contacts of an index patient
Incidence rate ratios among the contacts by proximity to the index patients will be calculated. Classification of contacts in proximity groups is a dynamic process. Persons belonging to the same household, surrounding households, entire village, or entire island may shift to closer proximity groups when leprosy patients are diagnosed in their environment. Since date of diagnosis, and any recent migration, will be recorded for each patient, we will be able to reallocate contacts to other circles and attribute to each contact a period of exposure within each circle.
Measured: The incidence rate ratio will be recorded during the 3-year recruitment period op the study.
Secondary outcomes (2)
Recent transmission cluster
Transmission links will be defined as identical genotypes based on their "variable number of tandem repeat(VNTR)"- profile. The definition of clustering will be based on comparison of the copy number of the VNTRs using two different stringencies: either considering those that presented identical copy number for all 17 alleles, or considering those that had identical copy number excluding the most variable loci.
Measured: All the samples over the three years should be analysed the able to fully explore the transmission links. Therefore, this outcome will be assessed through study completion, which will probably take1 year.
Patient and health system delay.
Mean patient and health systems delay with 95% confidence interval will be calculated. The questionnaire will comprise questions on the duration of the symptoms and the health seeking behavior of the patient.
Measured: This outcome can be calculated at the end of the recruitment phase of the study.Therefore, this outcome will be assessed through study completion, which will probably take1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Apr 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 889 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Damien Foundation, Programme National de lutte contre la Lèpre et la Tuberculose, Comores, Oswaldo Cruz Foundation, R2STOP
- Responsible party
- Sponsor
- Investigators
- Bouke C de Jong, MD,PhD, Principal investigator, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526718
- Sponsor's protocol ID
- 1147/16
- Acronym
- ComLep
- Status last verified
- May 2021
- First submitted
- 23 Apr 2018
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be considered once the datasets are locked at time of publication.
Publications
Marijke Braet S, Jouet A, Aubry A, Van Dyck-Lippens M, Lenoir E, Assoumani Y, Baco A, Mzembaba A, Cambau E, Vasconcellos SEG, Rigouts L, Suffys PN, Hasker E, Supply P, de Jong BC. Investigating drug resistance of Mycobacterium leprae in the Comoros: an observational deep-sequencing study. Lancet Microbe. 2022 Sep;3(9):e693-e700. doi: 10.1016/S2666-5247(22)00117-3. Epub 2022 Jul 15.
PubMed 35850123
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Understanding of Ongoing Transmission of Leprosy in the Comoros, a Region Hyperendemic for the Disease.
- ClinicalTrials.gov ID
- NCT03526718
- Acronym / sponsor ID
- ComLep / 1147/16
- Conditions
- Leprosy
- Keywords
- Transmission, Genotyping, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 889 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Damien Foundation, Programme National de lutte contre la Lèpre et la Tuberculose, Comores, Oswaldo Cruz Foundation, R2STOP
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 May 2018 (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.
Despite decades of a solid leprosy control program, including active case finding and follow-up on therapeutic outcome, the Comoros islands of Anjouan and Moheli continue to be hyperendemic for leprosy, with leprosy case notifications far exceeding those for tuberculosis, while the third island, Grande Comore, presents few cases. The high proportion (31% in 2015) of disease in children indicates that recent transmission is a major driver of the persistent endemicity, and that present control measures are not sufficient. The low proportion (2.6% average in last 10 years) of grade II disabilities in newly diagnosed cases indicates that case detection is early.
The main objective of the present proposal is to identify which persons would most benefit from prophylactic treatment. The secondary objective is to unravel human, bacterial and environmental risk factors for transmission of and progression to leprosy disease, with the ultimate goal to reduce the leprosy incidence.. The program has remaining expertise to re-establish laboratory confirmation of leprosy patients, allowing to optimize and validate molecular genotyping techniques to complement conventional epidemiological investigations in a 3-year prospective cohort of leprosy patients and their close contacts, aiming to identify transmission links. A third objective is to document diagnostic delays in more detail
As the leprosy control programme has initiated a pilot study on rifampicin prophylaxis in four villages on Anjouan in 2015, a prospective cohort study will permit measuring the leprosy incidence in close contacts as well as those in neighboring houses, who did or did not receive rifampicin prophylaxis.
The expected outcome of this project will be to identify risk factors for leprosy transmission. Specifically, we expect to identify those contacts at highest risk of developing leprosy disease, who would most benefit from rifampicin prophylaxis or other preventive measures.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Comoros islands, located between Madagascar and Mozambique, continue to be hyperendemic for leprosy. Periodic active case finding across the entire island of Anjouan is in place, resulting in early case detection, and every patient identified is being treated with highly effective multi drug therapy. Nevertheless, the high proportion of leprosy in children (31% were <15y old in 2015) in combination with a low relapse rate (<2%) indicate transmission continues unabated. The majority of the patients in Anjouan are paucibacillary.
Key inclusion criteria (2 listed)
- in the prospective cohort study: All newly diagnosed leprosy patients (any age) on the island of Anjouan who provide written informed consent.
- In the in-depth interviews: Patients who are part of a cluster and provide written informed consent. Additional written informed consent will be asked for questions in which the identity of other member(s) of a cluster needs to be revealed.
Key exclusion criteria (2 listed)
- in the prospective cohort study: None.
- In the in-depth interviews: Patients belonging to clusters not extending beyond the same first or second circle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Leprosy incidence among contacts of an index patient
Time frame: The incidence rate ratio will be recorded during the 3-year recruitment period op the study.
Incidence rate ratios among the contacts by proximity to the index patients will be calculated. Classification of contacts in proximity groups is a dynamic process. Persons belonging to the same household, surrounding households, entire village, or entire island may shift to closer proximity groups when leprosy patients are diagnosed in their environment. Since date of diagnosis, and any recent migration, will be recorded for each patient, we will be able to reallocate contacts to other circles and attribute to each contact a period of exposure within each circle.
2 secondary outcomes
Recent transmission cluster
Time frame: All the samples over the three years should be analysed the able to fully explore the transmission links. Therefore, this outcome will be assessed through study completion, which will probably take1 year.
Patient and health system delay.
Time frame: This outcome can be calculated at the end of the recruitment phase of the study.Therefore, this outcome will be assessed through study completion, which will probably take1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Derived from this study: PubMed 35850123Marijke Braet S, Jouet A, Aubry A, Van Dyck-Lippens M, Lenoir E, Assoumani Y, Baco A, Mzembaba A, Cambau E, Vasconcellos SEG, Rigouts L, Suffys PN, Hasker E, Supply P, de Jong BC. Investigating drug resistance of Mycobacterium leprae in the Comoros: an observational deep-sequencing study. Lancet Microbe. 2022 Sep;3(9):e693-e700. doi: 10.1016/S2666-5247(22)00117-3. Epub 2022 Jul 15.
- Individual participant dataSharing planned: Undecided. Data sharing will be considered once the datasets are locked at time of publication.
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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. This study is not recruiting at the moment.
Bouke C de Jong, MD,PhD principal investigator
Institute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leprosy, run by Institute of Tropical Medicine, Belgium at 1 site in Comoros.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 11 May 2021. 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 Comoros. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leprosy incidence among contacts of an index patient (time frame: The incidence rate ratio will be recorded during the 3-year recruitment period op the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03526718, which also lists 1 linked publication.
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 11 May 2021.