- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00344084
Surveillance for Leishmaniasis Skin Lesions in Mali
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.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bamako, Mali
- Faculty of Medicine Pharmacy and Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Herwaldt BL. Leishmaniasis. Lancet. 1999 Oct 2;354(9185):1191-9. doi: 10.1016/S0140-6736(98)10178-2.
- Mahe 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.
- el-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.
- Coulibaly 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.
- Oliveira 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999906121
- 06-I-N121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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