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CompletedNCT02784743Updated May 27, 2016

Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

A Phase 4 interventional study of ''albendazole'' and ''ivermectin'' in Lymphatic Filariasis, sponsored by Centre d'Appui à la lutte contre la Maladie. Completed. Open to participants aged 5 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-27.

Sponsored by Centre d'Appui à la lutte contre la Maladie · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,139
Allocation
Not applicable
Ages
5 Years to 65 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Lymphatic Filariasis

Keywords

  • Wuchereria bancrofti
  • Anopheles
  • Albendazole
  • Ivermectin
  • MDA
03

In context

Elephantiasis, Filarial

42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.

This study's enrollment of 1,139 is above the median of 1,000 across 27 interventional studies indexed under Elephantiasis, Filarial.

Browse Elephantiasis, Filarial studies →

Lead sponsor

Centre d'Appui à la lutte contre la Maladie is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • resident of the 6 villages
  • 5 years and above

Exclusion criteria

Exclusion Criteria:

  • pregnant women
  • breastfeeding women
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,139 participants (actual)

Study arms

  • 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''

Interventions

  • Drug''albendazole'' and ''ivermectin''

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

    Also known as: Zentel and Mectizan

06

What researchers measure

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

    Time frame: up to 7 months

Secondary outcomes

  1. 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

    Time frame: up to 12 months

  2. impact of albendazole ivermectin treatment on microfilaremia

    night thick smears on eligible volunteers 5 years and above

    Time frame: up to 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 26033027 ↗
  • 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. PubMed 23981378 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02784743
Lead sponsor
Centre d'Appui à la lutte contre la Maladie
Collaborators
Malaria Research and Training Center, Bamako, Mali, World Health Organization
Responsible party
Sponsor
First posted
May 27, 2016
Start date
May 2001
Primary completion
Dec 2008
Completion
Apr 2015
Last update
May 27, 2016

Study contacts

Sékou F Traoré, PhD
principal investigator · Malaria Research and Training Center, Mali

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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