NCT03352206

Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

Community Studies to Monitor the Impact of Triple Drug Therapy Relative to Double Drug Therapy on Lymphatic Filariasis Infection Indicators

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20,092 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

Summary

This study will assess the impact of 2-drug (DA) or 3-drug (IDA) regimens on lymphatic filariasis infection parameters in communities. Parameters measured will include: circulating filarial antigenemia (CFA) assessed with the Filariasis Test Strip (FTS), antifilarial antibodies tested with plasma and microfilaremia (assessed by night blood smears and microscopy).

Detailed description

Results from clinical trials in Papua New Guinea and Cote d'Ivoire have shown that a single dose of three drugs (ivermectin, diethylcarbamazine, and albendazole \[IDA\]) was superior to standard two drug therapy (diethylcarbamazine and albendazole \[DA\]) in clearing W. bancrofti microfilaremia (MF) (King et al. unpublished data).1 Recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if IDA was safe for use in mass drug administration (MDA) (DOLF Project, unpublished data). Currently, there is no information about what community indicators of infection look like following shorter IDA programs. It is possible that current WHO guidelines for stopping MDA need to be modified for MDA programs that use IDA. Observing the levels of infection indicators in a community following treatment with IDA will provide important information to the GPELF if IDA is recommended for use in MDA programs. There is an opportunity to study communities that were treated with IDA during the "Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis". Communities in this study were randomly assigned to receive IDA or DA treatment. A large percentage of individuals in these communities participated in the study thereby approximating a mass distribution of the treatments. By surveying these communities 12 months following their initial treatment the investigators will be able to better understand and compare the impact of MDA with IDA or DA on LF infection parameters at the level of communities.

Conditions

• Lymphatic Filariases

Interventions

Type	Name	Description
DRUG	2 drug dose - DA	Lymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine and albendazole (DA)
DRUG	3 drug dose - IDA	Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA)

Timeline

• Start date: 2017-10-18
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2017-11-24
• Last updated: 2020-12-31

Locations

5 sites across 5 countries: Fiji, Haiti, India, Indonesia, Papua New Guinea