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Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

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ClinicalTrials.gov Identifier: NCT02784743
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Collaborators:
Malaria Research and Training Center, Bamako, Mali
World Health Organization
Information provided by (Responsible Party):
Centre d'Appui à la lutte contre la Maladie

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.


Condition or disease Intervention/treatment Phase
Lymphatic Filariasis Drug: ''albendazole'' and ''ivermectin'' Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1139 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Albendazole -Ivermectin Combination Treatment on Wuchereria Bancrofti Infection and Transmission in Mali
Study Start Date : May 2001
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: albendazole and ivermectin
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).
Drug: ''albendazole'' and ''ivermectin''
annual single dose administration of albendazole 400mg and ivermectin 150ug/kg of weight (according to the height)
Other Name: Zentel and Mectizan




Primary Outcome Measures :
  1. vector infection and infectivity rates [ Time Frame: up to 7 months ]
    vectors are collected with human landing catch technique and the presence of Wb larvae stage s assessed using dissection method


Secondary Outcome Measures :
  1. Post MDA adverses events related to the drug albendazo and ivermectin [ Time Frame: up to 12 months ]
    after the administration of the drug the investigators assess the reaction to the treatment

  2. impact of albendazole ivermectin treatment on microfilaremia [ Time Frame: up to 12 months ]
    night thick smears on eligible volunteers 5 years and above



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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • resident of the 6 villages
  • 5 years and above

Exclusion Criteria:

  • pregnant women
  • breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784743


Sponsors and Collaborators
Centre d'Appui à la lutte contre la Maladie
Malaria Research and Training Center, Bamako, Mali
World Health Organization
Investigators
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Principal Investigator: Sékou F Traoré, PhD Malaria Research and Training Center, Mali

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Centre d'Appui à la lutte contre la Maladie
ClinicalTrials.gov Identifier: NCT02784743     History of Changes
Other Study ID Numbers: OMS/TDR ID# A00563
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016
Keywords provided by Centre d'Appui à la lutte contre la Maladie:
Wuchereria bancrofti
Anopheles
Albendazole
Ivermectin
MDA
Additional relevant MeSH terms:
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Filariasis
Elephantiasis, Filarial
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Ivermectin
Albendazole
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents