NCT02784743

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,139

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2001

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

7.6 years

First QC Date

April 29, 2015

Last Update Submit

May 24, 2016

Conditions

Lymphatic Filariasis

Keywords

Wuchereria bancroftiAnophelesAlbendazoleIvermectinMDA

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 7 months

Secondary Outcomes (2)

  • Post MDA adverses events related to the drug albendazo and ivermectin

    up to 12 months

  • impact of albendazole ivermectin treatment on microfilaremia

    up to 12 months

Study Arms (1)

albendazole and ivermectin

EXPERIMENTAL

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''

Interventions

''albendazole'' and ''ivermectin''DRUG

annual single dose administration of albendazole 400mg and ivermectin 150ug/kg of weight (according to the height)

Also known as: Zentel and Mectizan
albendazole and ivermectin

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • resident of the 6 villages
  • years and above

You may not qualify if:

  • pregnant women
  • breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26033027BACKGROUND

  • 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.

    PMID: 23981378RESULT

Related Links

MeSH Terms

Conditions

Elephantiasis, Filarial

Interventions

AlbendazoleIvermectin

Condition Hierarchy (Ancestors)

FilariasisSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesLymphedemaLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesPolyketidesLactones

Study Officials

  • Sékou F Traoré, PhD

    Malaria Research and Training Center, Mali

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 27, 2016

Study Start

May 1, 2001

Primary Completion

December 1, 2008

Study Completion

April 1, 2015

Last Updated

May 27, 2016

Record last verified: 2016-05