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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
Centre d'Appui à la lutte contre la Maladie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphatic Filariasis focused on measuring Wuchereria bancrofti, Anopheles, Albendazole, Ivermectin, MDA

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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

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    Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

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