Surveillance for Leishmaniasis Skin Lesions in Mali

NCT00344084 | Completed

• 2 other identifiers: 99990612106-I-N121
• Study Type: observational
• Target: 1,593
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cutaneous Leishmaniasis

Keywords

Leishmania Major; Phlebotomus Duboscqi; Dermatology; Vector-Transmitted Disease; Africa; Cutaneous Leishmaniasis; CL

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Faculty of Medicine Pharmacy and Dentistry

Bamako, Mali

Location

Related Publications (5)

• Herwaldt BL. Leishmaniasis. Lancet. 1999 Oct 2;354(9185):1191-9. doi: 10.1016/S0140-6736(98)10178-2.

  PMID: 10513726 BACKGROUND

• 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.

  PMID: 9762817 BACKGROUND

• 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.

  PMID: 1430361 BACKGROUND

• 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.

  PMID: 29898753 DERIVED

• 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.

  PMID: 20016847 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Vector Borne Diseases

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rick M Fairhurst, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 26, 2006
• Study Start: March 16, 2006
• Study Completion: September 17, 2012
• Last Updated: November 8, 2019

Record last verified: 2012-09-17

Locations

MA (1)