Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis

NCT01905423 | Completed Results

• 1 other identifier: 201103313
• Study Type: observational
• Target: 17,108
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 3,500 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis endemic areas. The study will be performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 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. Purpose of the study is to evaluate different mass drug administration (MDA) regimens for lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of this study may enhance efforts to control and eliminate these important neglected tropical diseases. The investigators will test the hypothesis that accelerated mass drug administration will be superior to annual MDA for elimination of lymphatic filariasis and for control of soil transmitted helminth infections (STH):

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

Conditions

Lymphatic Filariasis; Soil Transmitted Helminth Infections

Keywords

Filariasis; Albendazole; Diethylcarbamazine; STH Soil Transmitted Helminths; MDA Mass Drug Administration

Outcome Measures

Primary Outcomes (1)

• Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood

  Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual and semiannual community surveys. Prevalence rates (a measure of the disease rates in the population sampled) are expressed as % positive for microfilaremia (having microfilaria in the blood).

  3 years

Secondary Outcomes (5)

• Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests

  3 years

• Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test

  3 years

• Prevalence of Ascaris Infection

  2 Years

• Prevalence of Hookworm Infection

  2 years

• Prevalence of Trichuris Infection

  2 years

Study Arms (5)

Paga (annual MDA)

This group includes eligible residents of the village of Paga. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Paga received a total of three rounds of MDA over a period of 24 months (once every 12 months).

Drug: Albendazole (annual); Drug: Diethylcarbamazine (annual)

Lewomada (annual MDA)

This group includes eligible residents of the village of Lewomada. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Lewomada received a total of three rounds of MDA over a period of 24 months (once every 12 months).

Drug: Albendazole (annual); Drug: Diethylcarbamazine (annual)

Pruda (semiannual MDA)

This group includes eligible residents of the village of Pruda. This cohort will receive twice yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Pruda received a total of five rounds of MDA over a period of 24 months (once every 6 months).

Drug: Albendazole (semiannual); Drug: Diethylcarbamazine (semiannual)

Pekalongan (annual MDA)

This group includes the villages of Banyurip Ageng and Jenggot. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis.

Drug: Albendazole (annual); Drug: Diethylcarbamazine (annual)

Pekalongan (semiannual MDA)

This group includes the villages of Kertoharjo and Pabean. This cohort will receive twice yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis.

Drug: Albendazole (semiannual); Drug: Diethylcarbamazine (semiannual)

Interventions

Albendazole (annual) DRUG

Albendazole 400 mg pnce annually

Also known as: Albenza (Albendazole, also known as ALB)

Lewomada (annual MDA); Paga (annual MDA); Pekalongan (annual MDA)

Diethylcarbamazine (annual) DRUG

Diethylcarbamazine 6 mg/kg once annually

Also known as: Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02

Lewomada (annual MDA); Paga (annual MDA); Pekalongan (annual MDA)

Albendazole (semiannual) DRUG

Albendazole 400 mg twice annually

Also known as: Albenza (Albendazole, also known as ALB)

Pekalongan (semiannual MDA); Pruda (semiannual MDA)

Diethylcarbamazine (semiannual) DRUG

Diethylcarbamazine 6 mg/kg twice annually

Also known as: Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02

Pekalongan (semiannual MDA); Pruda (semiannual MDA)

Eligibility Criteria

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

Study Population

The study populations are people who live in areas of Indonesia that are endemic for lymphatic filariasis.

You may qualify if:

• Areas should be endemic for filariasis and 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

University of Indonesia, Department of Parasitology

Jakarta, Java, 10430, Indonesia

Location

Related Links

• Death to Onchocerciasis and Lymphatic Filariasis (DOLF)

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). We will also collect stool samples to detect STH infections. All assays will be performed in Indonesia (filarial serology tests, MF smears, stool examinations).

MeSH Terms

Conditions

Elephantiasis, Filarial; Filariasis

Interventions

Albendazole; Albumins; Diethylcarbamazine

Condition Hierarchy (Ancestors)

Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Proteins; Amino Acids, Peptides, and Proteins; Piperazines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Peter Fischer
• Organization: Washington University in St Louis Medical School

pufischer@wustl.edu

+1 (314) 747-5198

Study Officials

• Peter U Fischer, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Gary J Weil, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Taniawati Supali, Ph.D.

  Indonesia University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: April 11, 2012
• First Posted: July 23, 2013
• Study Start: May 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 17, 2020
• Results First Posted: October 16, 2017

Record last verified: 2020-10

Locations

ID (1)