Cutaneous LeishmaniasisNCT00344084
Surveillance for Leishmaniasis Skin Lesions in Mali
An observational study of Cutaneous Leishmaniasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
This study will examine why some people who become infected with the leishmaniasis parasite develop skin lesions and others do not. The parasite that causes leishmaniasis is transmitted by the bite of a sandfly. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cutaneous Leishmaniasis
- How many people
- 1,593 participants
- Where
- 1 siteMali
- Study dates
- 16 Mar 2006to 17 Sep 2012
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- ELIGIBILITY CRITERIA:
Only consented volunteers who are permanent residents of Kemena or Sougoula, and who do not have known sensitivity to thiomerosal, will be invited to participate in this study. Otherwise, inclusion criteria specific for each phase of this study are as follows:
Administration of LST, April-May 2006:
Age greater than or equal to 1
Active and passive detection of CL, August-December 2006:
LST negative status in April 2006.
Aspiration of CL lesions, August-December 2006:
Age greater than or equal to18 years, AND
Presence of one or more clinically diagnosed CL lesion
Re-administration of LST in February-March 2007:
LST negative status in April 2006
Collection of whole blood for immunological studies, May 2007 - May 2008:
Age greater than or equal to 3 years and less than or equal to 65 years, AND
LST negative status in February-March 2007.
Active detection of CL, May 2007- May 2008:
LST negative status in February-March 2007.
Aspiration of CL lesions, May 2007 - May 2008:
Age greater than or equal to 3 years, AND
Presence of at least one PCR-diagnosed CL lesion.
Collection of fingerprick blood sample, January-March 2008:
Currently or previously enrolled on protocol
Re-administration of LST, June-July 2008:
LST negative status in February-March 2007.
Collection of whole blood for immunological studies, June - August 2008:
Age greater than or equal to 3 years and less than or equal to 65 years, AND
LST negative status in February-March 2007, AND
One of the following:
Conversion from negative to positive LST reaction during the study period, OR
Occurrence of greater than or equal to 1 PCR-confirmed CL lesion during 10-month survey period, regardless of June-July 2008 LST result, OR
Repeat LST negative result and absence of PCR-confirmed CL lesion during 10-month surveillance period.
Collection of whole blood from healthy volunteers naturally exposed to P. duboscqi October 2008-October 2012
Aqe greater than or equal to 11 years and less than or equal to 65 years, AND resident of Kemena or Sougoula OR patient with a Giemsa stain-confirmed CL lesion beinq evaluated and treated bY study physicians at CNAM in Bamako.
Exposure of individuals to the bites of laboratory-reared, noninfected P. duboscai October 2008-October 2012
Age greater than or equal to 1 years and less than or equal to 65 years AND resident of Kemena or Souaoula.
Dermal biopsy of DTH reactions occurring in individuals exposed to the bites of laboratory-reared, noninfected P. duboscai October 2008- October 2012
Age 18-65 years AND resident of Kemena or Souqoula.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Surveillance for Cutaneous Leishmaniasis in Mali
This study will examine why some people who become infected with the leishmaniasis parasite develop skin lesions and others do not. The parasite that causes leishmaniasis is transmitted by the bite of a sandfly. It can cause skin lesions that may persist for several months, spread to other parts of the body, and become infected with bacteria. Treated with medicine, leishmaniasis can be cured completely.
People 1 year of age and older who live in the Mali villages of Kemena or Sougoula may be eligible for this study.
Read more
Participants are injected with a small amount of inactive parasites into the skin of their arm. People who have a reaction to the test, and thus have been exposed to the parasite, are examined for skin lesions. Their lesions, if any, are evaluated and treated, and their participation in the study ends.
Participants who do not react to the skin test are examined for skin lesions every month for 5 months. Those who are 18 years of age or older and have mild leishmaniasis skin lesions may have a small amount of fluid injected into a lesion in order to remove parasites for laboratory analysis.
Patients' lesions may be photographed to compare what they look like before and after treatment. Lesions are treated with an ointment containing an antibiotic and a disinfectant twice a day for 20 days. The lesions are examined 1 and 3 weeks after treatment is completed to see if the disease has been cured. A few months later, the skin test is repeated to determine whether the person has been exposed to parasites over the past year.
A blood sample may be drawn from some participants, depending on whether they have a reaction to the second skin test and whether they have developed skin lesions. The sample is drawn only from patients 18-65 years of age.
Some blood drawn for the study may be used for genetic tests.
Read the detailed description
The overarching aim of the research program is to develop a vaccine against cutaneous leishmaniasis (CL) based on sandfly salivary proteins (SFSPs). In order to determine whether vaccination with SFSPs can reduce the subsequent incidence of Leishmania major infections or CL in humans, it is first necessary to establish baseline rates of parasite infection and disease. We have selected two rural villages in central Mali where we have readily observed CL lesions in individuals of all ages and large numbers of sandflies that are known to transmit L. major in West Africa. The main objectives of this study are to estimate a cross-sectional prevalence of L. major exposure; to determine the prevalence of CL; to determine an annual incidence rate of L. major infection; and to determine whether robust in vitro T and B cell responses to SFSPs correlate with protection against newly acquired L. major infection or CL. To meet these objectives, a standard leishmanin skin test (LST) will be administered to all residents of two Malian villages in order to identify a cohort of subjects who are at risk for newly acquired L. major. After the sandfly biting and disease transmission seasons, all subjects will be examined for the development of CL lesions every month for 5 months total. CL lesions will be treated topically with paromomycin- methylbenzethonium chloride ointment twice daily for 20 days. Response to therapy will be documented on days 28 and 42 of the protocol. After allowing adequate time for the development of delayed-type hypersensitivity responses to parasite antigens, LSTs will be re-administered to all subjects. Conversion from a negative to positive LST will be taken as evidence of newly acquired L. major infection. LST conversion data and clinical diagnosis of CL lesions will allow us to calculate both the incidence of new L. major infections and CL in our study population. In vitro T and B cell responses to SFSPs will be measured from a subset of individuals and correlated with relative resistance to both L. major infection and the development of clinically apparent lesions.
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Leishmania Major, Phlebotomus Duboscqi, Dermatology, Vector-Transmitted Disease, Africa, Cutaneous Leishmaniasis, CL
- Medical subject headings
- Leishmaniasis, Cutaneous, Vector Borne Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study start16 Mar 2006
- Study completion17 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cutaneous LeishmaniasisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Enrolment
- 1,593 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Rick M Fairhurst, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344084
- Sponsor's protocol ID
- 999906121
- Other IDs
- 06-I-N121
- Status last verified
- 17 Sep 2012
- First submitted
- 23 Jun 2006
- Last updated
- 8 Nov 2019
- Results posted
- No
Publications
Herwaldt BL. Leishmaniasis. Lancet. 1999 Oct 2;354(9185):1191-9. doi: 10.1016/S0140-6736(98)10178-2.
PubMed 10513726Mahe A, Cisse IAh, Faye O, N'Diaye HT, Niamba P. Skin diseases in Bamako (Mali). Int J Dermatol. 1998 Sep;37(9):673-6. doi: 10.1046/j.1365-4362.1998.00454.x.
PubMed 9762817el-On J, Halevy S, Grunwald MH, Weinrauch L. Topical treatment of Old World cutaneous leishmaniasis caused by Leishmania major: a double-blind control study. J Am Acad Dermatol. 1992 Aug;27(2 Pt 1):227-31. doi: 10.1016/0190-9622(92)70175-f.
PubMed 1430361Coulibaly CA, Traore B, Dicko A, Samake S, Sissoko I, Anderson JM, Valenzuela J, Traore SF, Faye O, Kamhawi S, Oliveira F, Doumbia S. Impact of insecticide-treated bednets and indoor residual spraying in controlling populations of Phlebotomus duboscqi, the vector of Leishmania major in Central Mali. Parasit Vectors. 2018 Jun 14;11(1):345. doi: 10.1186/s13071-018-2909-2.
PubMed 29898753Oliveira F, Doumbia S, Anderson JM, Faye O, Diarra SS, Traore P, Cisse M, Camara G, Tall K, Coulibaly CA, Samake S, Sissoko I, Traore B, Diallo D, Keita S, Fairhurst RM, Valenzuela JG, Kamhawi S. Discrepant prevalence and incidence of Leishmania infection between two neighboring villages in Central Mali based on Leishmanin skin test surveys. PLoS Negl Trop Dis. 2009 Dec 15;3(12):e565. doi: 10.1371/journal.pntd.0000565.
PubMed 20016847
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance for Cutaneous Leishmaniasis in Mali
- ClinicalTrials.gov ID
- NCT00344084
- Acronym / sponsor ID
- 999906121
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Leishmania Major, Phlebotomus Duboscqi, Dermatology, Vector-Transmitted Disease, Africa, Cutaneous Leishmaniasis, CL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,593 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 16 Mar 2006
- Study completion
- 17 Sep 2012
- First posted
- 26 Jun 2006 (estimated)
- 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.
This study will examine why some people who become infected with the leishmaniasis parasite develop skin lesions and others do not. The parasite that causes leishmaniasis is transmitted by the bite of a sandfly. It can cause skin lesions that may persist for several months, spread to other parts of the body, and become infected with bacteria. Treated with medicine, leishmaniasis can be cured completely.
People 1 year of age and older who live in the Mali villages of Kemena or Sougoula may be eligible for this study.
Participants are injected with a small amount of inactive parasites into the skin of their arm. People who have a reaction to the test, and thus have been exposed to the parasite, are examined for skin lesions. Their lesions, if any, are evaluated and treated, and their participation in the study ends.
Participants who do not react to the skin test are examined for skin lesions every month for 5 months. Those who are 18 years of age or older and have mild leishmaniasis skin lesions may have a small amount of fluid injected into a lesion in order to remove parasites for laboratory analysis.
Patients' lesions may be photographed to compare what they look like before and after treatment. Lesions are treated with an ointment containing an antibiotic and a disinfectant twice a day for 20 days. The lesions are examined 1 and 3 weeks after treatment is completed to see if the disease has been cured. A few months later, the skin test is repeated to determine whether the person has been exposed to parasites over the past year.
A blood sample may be drawn from some participants, depending on whether they have a reaction to the second skin test and whether they have developed skin lesions. The sample is drawn only from patients 18-65 years of age.
Some blood drawn for the study may be used for genetic tests.
Detailed description
The overarching aim of the research program is to develop a vaccine against cutaneous leishmaniasis (CL) based on sandfly salivary proteins (SFSPs). In order to determine whether vaccination with SFSPs can reduce the subsequent incidence of Leishmania major infections or CL in humans, it is first necessary to establish baseline rates of parasite infection and disease. We have selected two rural villages in central Mali where we have readily observed CL lesions in individuals of all ages and large numbers of sandflies that are known to transmit L. major in West Africa. The main objectives of this study are to estimate a cross-sectional prevalence of L. major exposure; to determine the prevalence of CL; to determine an annual incidence rate of L. major infection; and to determine whether robust in vitro T and B cell responses to SFSPs correlate with protection against newly acquired L. major infection or CL. To meet these objectives, a standard leishmanin skin test (LST) will be administered to all residents of two Malian villages in order to identify a cohort of subjects who are at risk for newly acquired L. major. After the sandfly biting and disease transmission seasons, all subjects will be examined for the development of CL lesions every month for 5 months total. CL lesions will be treated topically with paromomycin- methylbenzethonium chloride ointment twice daily for 20 days. Response to therapy will be documented on days 28 and 42 of the protocol. After allowing adequate time for the development of delayed-type hypersensitivity responses to parasite antigens, LSTs will be re-administered to all subjects. Conversion from a negative to positive LST will be taken as evidence of newly acquired L. major infection. LST conversion data and clinical diagnosis of CL lesions will allow us to calculate both the incidence of new L. major infections and CL in our study population. In vitro T and B cell responses to SFSPs will be measured from a subset of individuals and correlated with relative resistance to both L. major infection and the development of clinically apparent lesions.
Study design
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 8 Nov 2019.
- Background: PubMed 10513726Herwaldt BL. Leishmaniasis. Lancet. 1999 Oct 2;354(9185):1191-9. doi: 10.1016/S0140-6736(98)10178-2.
- Background: PubMed 9762817Mahe A, Cisse IAh, Faye O, N'Diaye HT, Niamba P. Skin diseases in Bamako (Mali). Int J Dermatol. 1998 Sep;37(9):673-6. doi: 10.1046/j.1365-4362.1998.00454.x.
- Background: PubMed 1430361el-On J, Halevy S, Grunwald MH, Weinrauch L. Topical treatment of Old World cutaneous leishmaniasis caused by Leishmania major: a double-blind control study. J Am Acad Dermatol. 1992 Aug;27(2 Pt 1):227-31. doi: 10.1016/0190-9622(92)70175-f.
- Derived from this study: PubMed 29898753Coulibaly CA, Traore B, Dicko A, Samake S, Sissoko I, Anderson JM, Valenzuela J, Traore SF, Faye O, Kamhawi S, Oliveira F, Doumbia S. Impact of insecticide-treated bednets and indoor residual spraying in controlling populations of Phlebotomus duboscqi, the vector of Leishmania major in Central Mali. Parasit Vectors. 2018 Jun 14;11(1):345. doi: 10.1186/s13071-018-2909-2.
- Derived from this study: PubMed 20016847Oliveira F, Doumbia S, Anderson JM, Faye O, Diarra SS, Traore P, Cisse M, Camara G, Tall K, Coulibaly CA, Samake S, Sissoko I, Traore B, Diallo D, Keita S, Fairhurst RM, Valenzuela JG, Kamhawi S. Discrepant prevalence and incidence of Leishmania infection between two neighboring villages in Central Mali based on Leishmanin skin test surveys. PLoS Negl Trop Dis. 2009 Dec 15;3(12):e565. doi: 10.1371/journal.pntd.0000565.
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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.
Rick M Fairhurst, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Cutaneous Leishmaniasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Nov 2019. 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 Mali. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344084, which also lists 5 linked publications.
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 8 Nov 2019.