Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali
Primary Purpose
Lymphatic Filariasis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
''albendazole'' and ''ivermectin''
Sponsored by
About this trial
This is an interventional treatment trial for Lymphatic Filariasis focused on measuring Wuchereria bancrofti, Anopheles, Albendazole, Ivermectin, MDA
Eligibility Criteria
Inclusion Criteria:
- resident of the 6 villages
- 5 years and above
Exclusion Criteria:
- pregnant women
- breastfeeding women
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
albendazole and ivermectin
Arm Description
Before and after design with all eligible volunteers receiving the study drugs. Administration of a yearly unique dose of albendazole 400mg and ivermectin 150ug/kg weight ( according to the height).
Outcomes
Primary Outcome Measures
vector infection and infectivity rates
vectors are collected with human landing catch technique and the presence of Wb larvae stage s assessed using dissection method
Secondary Outcome Measures
Post MDA adverses events related to the drug albendazo and ivermectin
after the administration of the drug the investigators assess the reaction to the treatment
impact of albendazole ivermectin treatment on microfilaremia
night thick smears on eligible volunteers 5 years and above
Full Information
NCT ID
NCT02784743
First Posted
April 29, 2015
Last Updated
May 24, 2016
Sponsor
Centre d'Appui à la lutte contre la Maladie
Collaborators
Malaria Research and Training Center, Bamako, Mali, World Health Organization
1. Study Identification
Unique Protocol Identification Number
NCT02784743
Brief Title
Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali
Official Title
Impact of Albendazole -Ivermectin Combination Treatment on Wuchereria Bancrofti Infection and Transmission in Mali
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Appui à la lutte contre la Maladie
Collaborators
Malaria Research and Training Center, Bamako, Mali, World Health Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date and most of them are more than 15 years old. To address this issue in April 2000, the investigators started studies to update the epidemiology of lymphatic filariasis. There is no ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive chemotherapy treatment or vector control.
To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly endemic villages of Mali.
Detailed Description
Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date and most of them are more than 15 years old. To address this issue in April 2000, the investigators started studies to update the epidemiology of lymphatic filariasis. As a result, in two rural areas (Banambani and Sirakoro) located at about 25 km North-East Bamako, the parasite prevalence using ICT cards in August 2000 were 16% (n=150) and 15.0% (n=113) respectively in Banambani and Sirakoro. There is no ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive chemotherapy treatment or vector control.
To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly endemic villages of Mali.
The study will be conducted in three phases: the pre treatment assessment of lymphatic filariasis infection and transmission parameters, treatment phase with annual single dose of albendazole and ivermectin and the post treatment assessment of Anopheles gambiae s.l mosquitoes, the transmission parameters of the vectors in the community, human infection prevalence post treatment using Giemsa -stained thick smears and others test like the Immuno chromatographic test (ICT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Filariasis
Keywords
Wuchereria bancrofti, Anopheles, Albendazole, Ivermectin, MDA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
albendazole and ivermectin
Arm Type
Experimental
Arm Description
Before and after design with all eligible volunteers receiving the study drugs. Administration of a yearly unique dose of albendazole 400mg and ivermectin 150ug/kg weight ( according to the height).
Intervention Type
Drug
Intervention Name(s)
''albendazole'' and ''ivermectin''
Other Intervention Name(s)
Zentel and Mectizan
Intervention Description
annual single dose administration of albendazole 400mg and ivermectin 150ug/kg of weight (according to the height)
Primary Outcome Measure Information:
Title
vector infection and infectivity rates
Description
vectors are collected with human landing catch technique and the presence of Wb larvae stage s assessed using dissection method
Time Frame
up to 7 months
Secondary Outcome Measure Information:
Title
Post MDA adverses events related to the drug albendazo and ivermectin
Description
after the administration of the drug the investigators assess the reaction to the treatment
Time Frame
up to 12 months
Title
impact of albendazole ivermectin treatment on microfilaremia
Description
night thick smears on eligible volunteers 5 years and above
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
resident of the 6 villages
5 years and above
Exclusion Criteria:
pregnant women
breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sékou F Traoré, PhD
Organizational Affiliation
Malaria Research and Training Center, Mali
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26033027
Citation
Coulibaly YI, Dembele B, Diallo AA, Konate S, Dolo H, Coulibaly SY, Doumbia SS, Soumaoro L, Coulibaly ME, Bockarie MJ, Molyneux D, Nutman TB, Klion AD, Toure YT, Traore SF. The Impact of Six Annual Rounds of Mass Drug Administration on Wuchereria bancrofti Infections in Humans and in Mosquitoes in Mali. Am J Trop Med Hyg. 2015 Aug;93(2):356-60. doi: 10.4269/ajtmh.14-0516. Epub 2015 Jun 1.
Results Reference
background
PubMed Identifier
23981378
Citation
Coulibaly YI, Dembele B, Diallo AA, Kristensen S, Konate S, Dolo H, Dicko I, Sangare MB, Keita F, Boatin BA, Traore AK, Nutman TB, Klion AD, Toure YT, Traore SF. Wuchereria bancrofti transmission pattern in southern Mali prior to and following the institution of mass drug administration. Parasit Vectors. 2013 Aug 28;6(1):247. doi: 10.1186/1756-3305-6-247.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23981378
Description
Abstract of Baseline and first mass drug adminstration data
Learn more about this trial
Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali
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