Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

NCT ID: NCT02784743

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2015-04-30

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).

Conditions

Lymphatic Filariasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

''albendazole'' and ''ivermectin''

Intervention Type: DRUG

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

Interventions

''albendazole'' and ''ivermectin''

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

Intervention Type: DRUG

Other Intervention Names

Zentel and Mectizan

Eligibility Criteria

Inclusion Criteria

• resident of the 6 villages
• 5 years and above

Exclusion Criteria

• pregnant women
• breastfeeding women

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Malaria Research and Training Center, Bamako, Mali

OTHER

Sponsor Role: collaborator

World Health Organization

OTHER

Sponsor Role: collaborator

Centre d'Appui à la lutte contre la Maladie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sékou F Traoré, PhD

Role: PRINCIPAL_INVESTIGATOR

Malaria Research and Training Center, Mali

References

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.

Reference Type: BACKGROUND

PMID: 26033027 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23981378 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/23981378

Abstract of Baseline and first mass drug adminstration data

Other Identifiers

OMS/TDR ID# A00563

Identifier Type: -

Identifier Source: org_study_id