Clinical trial NCT02784743: Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali
Official title: Impact of Albendazole -Ivermectin Combination Treatment on Wuchereria Bancrofti Infection and Transmission in Mali
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphatic Filariasis
Keywords: Wuchereria bancrofti
Anopheles
Albendazole
Ivermectin
MDA
Lead sponsor: Centre d'Appui à la lutte contre la Maladie
Sponsor class: OTHER
Collaborators: name: Malaria Research and Training Center, Bamako, Mali
name: World Health Organization
First posted: 2016-05-27
Enrollment: 1139
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* resident of the 6 villages
* 5 years and above

Exclusion Criteria:

* pregnant women
* breastfeeding women

Primary outcomes:
measure: vector infection and infectivity rates
timeFrame: up to 7 months
Secondary outcomes:
measure: Post MDA adverses events related to the drug albendazo and ivermectin
timeFrame: up to 12 months
measure: impact of albendazole ivermectin treatment on microfilaremia
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Malaria Research and Training Center, Mali
name: Sékou F Traoré, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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, 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.