Surveillance for Leishmaniasis Skin Lesions in Mali
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|ClinicalTrials.gov Identifier: NCT00344084|
Recruitment Status : Completed
First Posted : June 26, 2006
Last Update Posted : June 20, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1593 participants|
|Official Title:||Active Surveillance for Cutaneous Leishmaniasis in Mali|
|Study Start Date :||March 16, 2006|
|Study Completion Date :||September 17, 2012|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344084
|Faculty of Medicine Pharmacy and Dentistry|
|Principal Investigator:||Rick M Fairhurst, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|