Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast (DOLF-Ivory Coast)

NCT02032043 | Completed

• 1 other identifier: 201306100
• Study Type: observational
• Target: 14,457
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 4,000 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis and onchocerciasis endemic areas. Subject selection will not be based on health status. Two sites will be studied, and each study will last for 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these MDA schedules on soil transmitted helminth infections. MDA will be administered by others (Ivorian Ministry of Health). The investigators will test the hypothesis that semiannual mass drug administration (MDA) is superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for control of soil transmitted helminth (STH) infections.

1. 1.Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.
2. 2.Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations.
3. 3.Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.

Conditions

Lymphatic Filariasis; Onchocerciasis; Soil Transmitted Helminth (STH) Infections

Keywords

Filariasis; Onchocerciasis; Albendazole; Ivermectin; STH Soil Transmitted Helminth infections; MDA Mass Drug Administration

Outcome Measures

Primary Outcomes (1)

• Microfilaria prevalence based on results of microscopic examination of blood smears and skin snips.

  From annual population based surveys, the prevalence of microfilaremia (filarial parasites in the blood or skin snips) will be assessed by microscopic examination of slides with thick blood smears and skin snips. Test results for individuals are either positive or negative. The unit for prevalence studies is the percentage (%) of individuals with positive tests.

  4 years

Secondary Outcomes (1)

• Prevalence of filarial antigenemia in blood and intensity of filarial and intestinal worm infections based on results of microscopy.

  4 years

Study Arms (2)

Annual MDA treated Group

This group will receive annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Ivorian Ministry of Health.

Drug: Annual versus Semiannual Albendazole plus Ivermectin MDA

Semiannual Mass Drug Administration

This group will receive semi-annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Ivorian Ministry of Health.

Drug: Annual versus Semiannual Albendazole plus Ivermectin MDA

Interventions

Annual versus Semiannual Albendazole plus Ivermectin MDA DRUG

Annual or semiannual Albendazole plus Ivermectin, administered by the Ivorian Ministry of Health.

Also known as: Albenza (Albendazole); Mectizan (Ivermectin)

Annual MDA treated Group; Semiannual Mass Drug Administration

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study populations are people who live in areas of Ivory Coast that are co-endemic for lymphatic filariasis and onchocerciasis.

You may qualify if:

• Study areas should be endemic for filariasis and onchocerciasis.
• Study population have limited or no prior experience with MDA. Males and Females greater than or equal to 5 years of age.

You may not qualify if:

• Children less than 5 years of age.
• Children who weigh less than 15 kg (33 lb)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Ivory Coast National Program Against Schistosomiasis, Geohelminths and Filariasis

Abidjan, Lagune-Cocody, Côte d’Ivoire

Location

Related Publications (1)

• Loukouri A, Meite A, Koudou BG, Goss CW, Lew D, Weil GJ, N'Goran EK, Fischer PU. Impact of annual and semi-annual mass drug administration for Lymphatic Filariasis and Onchocerciasis on Hookworm Infection in Cote d'Ivoire. PLoS Negl Trop Dis. 2020 Sep 25;14(9):e0008642. doi: 10.1371/journal.pntd.0008642. eCollection 2020 Sep.

  PMID: 32976514 DERIVED

Related Links

• Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Project

Biospecimen

Retention: SAMPLES WITHOUT DNA

Study procedures include collection of finger prick blood that will be tested for microfilaremia and for serology testing (antigenemia and antibody testing). Investigators will also collect skin snips (small superficial skin biopsies) to detect Onchocerca microfilariae, and stool samples to detect parasitic worm eggs indicative of STH infections. All assays will be performed in Ivory Coast(filarial serology tests, MF smears, stool examinations).

MeSH Terms

Conditions

Elephantiasis, Filarial; Onchocerciasis; Infections; Filariasis

Interventions

Albendazole; Ivermectin

Condition Hierarchy (Ancestors)

Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones

Study Officials

• Gary J Weil, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Peter U Fischer, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Aboulaye Miete, MD

  Ivory Coast Ministry of Health, National Program Against Filariasis, Schistosomiasis and Geohelminths

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine/Microbiology

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: February 1, 2014
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

CÔ (1)