Status:
COMPLETED
Surveillance for Leishmaniasis Skin Lesions in Mali
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
1+ years
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...
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 SFSP...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA:
- Only consented volunteers who are permanent residents of Kemena or Sougoula, and who do not have known sensitivity to thiomerosal, will be invited to participate in this study. Otherwise, inclusion criteria specific for each phase of this study are as follows:
- 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:
- Age greater than or equal to 3 years, AND
- Presence of at least one PCR-diagnosed CL lesion.
- Collection of fingerprick blood sample, January-March 2008:
- Currently or previously enrolled on protocol
- Re-administration of LST, June-July 2008:
- LST negative status in February-March 2007.
- Collection of whole blood for immunological studies, June - August 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, AND
- One of the following:
- Conversion from negative to positive LST reaction during the study period, OR
- Occurrence of greater than or equal to 1 PCR-confirmed CL lesion during 10-month survey period, regardless of June-July 2008 LST result, OR
- Repeat LST negative result and absence of PCR-confirmed CL lesion during 10-month surveillance period.
- Collection of whole blood from healthy volunteers naturally exposed to P. duboscqi October 2008-October 2012
- Aqe greater than or equal to 11 years and less than or equal to 65 years, AND resident of Kemena or Sougoula OR patient with a Giemsa stain-confirmed CL lesion beinq evaluated and treated bY study physicians at CNAM in Bamako.
- Exposure of individuals to the bites of laboratory-reared, noninfected P. duboscai October 2008-October 2012
- Age greater than or equal to 1 years and less than or equal to 65 years AND resident of Kemena or Souaoula.
- Dermal biopsy of DTH reactions occurring in individuals exposed to the bites of laboratory-reared, noninfected P. duboscai October 2008- October 2012
- Age 18-65 years AND resident of Kemena or Souqoula.
Exclusion
Key Trial Info
Start Date :
March 16 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 17 2012
Estimated Enrollment :
1593 Patients enrolled
Trial Details
Trial ID
NCT00344084
Start Date
March 16 2006
End Date
September 17 2012
Last Update
November 8 2019
Active Locations (1)
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1
Faculty of Medicine Pharmacy and Dentistry
Bamako, Mali