Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

Lymphatic Filariasis Clinical Trial

Official title:

Impact of Albendazole -Ivermectin Combination Treatment on Wuchereria Bancrofti Infection and Transmission in Mali

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784743
• Other study ID #: OMS/TDR ID# A00563
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2015
• Last updated: May 24, 2016
• Start date: May 2001
• Est. completion date: April 2015

Study information

• Verified date: May 2016
• Source: Centre d'Appui à la lutte contre la Maladie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: comités d'éthique
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1139
• Est. completion date: April 2015
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 65 Years

Eligibility

Inclusion Criteria:

• resident of the 6 villages

• 5 years and above

Exclusion Criteria:

• pregnant women

• breastfeeding women

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Filariasis
• Lymphatic Filariasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Centre d'Appui à la lutte contre la Maladie	Malaria Research and Training Center, Bamako, Mali, World Health Organization

References & Publications (2)

Coulibaly YI, Dembele B, Diallo AA, Konaté 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. — View 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, Touré YT, Traore SF. Wuchereria bancrofti transmission pattern in southern Mali prior to and following the institu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	up to 12 months	Yes
Secondary	impact of albendazole ivermectin treatment on microfilaremia	night thick smears on eligible volunteers 5 years and above	up to 12 months	Yes

External Links

•   Abstract of Baseline and first mass drug adminstration data