N/A
N=17,108
Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis
Lymphatic Filariasis · Soil Transmitted Helminth Infections
Bottom Line
View on ClinicalTrials.gov: NCT01905423 ↗Enrolled (actual)
17,108
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood — 54; 36; 146; 46 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Albendazole (annual) (Drug); Diethylcarbamazine (annual) (Drug); Albendazole (semiannual) (Drug); Diethylcarbamazine (semiannual) (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood |
54; 36; 146; 46; 45; 11 | — |
| SECONDARY Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests |
175; 229; 297; 0; 0; 0 | — |
| SECONDARY Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test |
14; 47; 235; 118; 102; 0 | — |
| SECONDARY Prevalence of Ascaris Infection |
88; 56; 34; 19; 58; 135 | — |
| SECONDARY Prevalence of Hookworm Infection |
25; 226; 35; 0; 0; 118 | — |
| SECONDARY Prevalence of Trichuris Infection |
68; 45; 8; 120; 352; 93 | — |
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. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF).
2. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Children less than 5 years of age.
Data sourced from ClinicalTrials.gov (NCT01905423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.