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Surveillance for Leishmaniasis Skin Lesions in Mali

NCT00344084 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1593

Last updated 2019-11-08

No results posted yet for this study

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Rick M Fairhurst, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-16
Completion
2012-09-17

Countries

  • Mali

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00344084 on ClinicalTrials.gov