Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344084
Status:
COMPLETED
Last Update Posted:
2019-11-08
First Post:
2006-06-23
Brief Title:
Surveillance for Leishmaniasis Skin Lesions in Mali
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Active Surveillance for Cutaneous Leishmaniasis in Mali
Status:
COMPLETED
Status Verified Date:
2012-09-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The overarching aim of the research program is to develop a vaccine against cutaneous leishmaniasis CL based on sandfly salivary proteins SFSPs In order to determine whether vaccination with SFSPs can reduce the subsequent incidence of Leishmania major infections or CL in humans it is first necessary to establish baseline rates of parasite infection and disease We have selected two rural villages in central Mali where we have readily observed CL lesions in individuals of all ages and large numbers of sandflies that are known to transmit L major in West Africa The main objectives of this study are to estimate a cross-sectional prevalence of L major exposure to determine the prevalence of CL to determine an annual incidence rate of L major infection and to determine whether robust in vitro T and B cell responses to SFSPs correlate with protection against newly acquired L major infection or CL To meet these objectives a standard leishmanin skin test LST will be administered to all residents of two Malian villages in order to identify a cohort of subjects who are at risk for newly acquired L major After the sandfly biting and disease transmission seasons all subjects will be examined for the development of CL lesions every month for 5 months total CL lesions will be treated topically with paromomycin- methylbenzethonium chloride ointment twice daily for 20 days Response to therapy will be documented on days 28 and 42 of the protocol After allowing adequate time for the development of delayed-type hypersensitivity responses to parasite antigens LSTs will be re-administered to all subjects Conversion from a negative to positive LST will be taken as evidence of newly acquired L major infection LST conversion data and clinical diagnosis of CL lesions will allow us to calculate both the incidence of new L major infections and CL in our study population In vitro T and B cell responses to SFSPs will be measured from a subset of individuals and correlated with relative resistance to both L major infection and the development of clinically apparent lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-N121 | None | None | None |