NCT00344084

Surveillance for Leishmaniasis Skin Lesions in Mali

Completed Last updated 8 November 2019

What this trial tests

trial in Cutaneous Leishmaniasis in 1,593 participants. Completed in 17 September 2012.

Timeline

16 March 2006

17 September 2012

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,593
Start date	16 March 2006
Estimated completion	17 September 2012
Sites	1 location across Mali

Conditions studied

• Cutaneous Leishmaniasis — all drugs for Cutaneous Leishmaniasis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

1 and older, any sex, with Cutaneous Leishmaniasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Delayed-type hypersensitivity to sand fly saliva in humans from a leishmaniasis-endemic area of Mali is Th1-mediated and persists to midlife.
   Oliveira F, Traoré B, Gomes R, Faye O, et al · · 2013 · cited 45× · PMID 22992802 · DOI 10.1038/jid.2012.315
2. Discrepant prevalence and incidence of Leishmania infection between two neighboring villages in Central Mali based on Leishmanin skin test surveys.
   Oliveira F, Doumbia S, Anderson JM, Faye O, et al · · 2009 · cited 20× · PMID 20016847 · DOI 10.1371/journal.pntd.0000565
3. Impact of insecticide-treated bednets and indoor residual spraying in controlling populations of Phlebotomus duboscqi, the vector of Leishmania major in Central Mali.
   Coulibaly CA, Traore B, Dicko A, Samake S, et al · · 2018 · cited 5× · PMID 29898753 · DOI 10.1186/s13071-018-2909-2