Optimization of MDA With Existing Drug Regimens for LF: Monitoring Efficacy of Ongoing Treatment Programs in PNG (MDA)
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|ClinicalTrials.gov Identifier: NCT03268252|
Recruitment Status : Completed
First Posted : August 31, 2017
Last Update Posted : April 26, 2019
|Condition or disease|
This research will conduct a population-based field studies to determine whether the relative cost and efficacy of semi-annual versus annual administration of MDA using DEC (6 mg/kg body weight) plus ALB 400 mg (for all individuals regardless of weight) will be more successful in elimination of LF and reduction in the burden of soil transmitted helminth (worm) infections. The study involving participation of human subjects is observational in nature, uses drugs that are the standard approved treatment for LF in PNG and elsewhere in the Pacific and Asia, and does not involve administration of drugs by the investigators. Diagnosis of LF and administration of anti-LF drugs will be the responsibility of those authorized by the PNG Department of Health to perform this activity.
The study design is repeated cross-sectional surveys examining each subject once. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Approximately 3,200 individuals will participate per year at the beginning of the study and at years 1, 2 and 3 (a total of 4 cross-sectional surveys). The study will include both females and males 5 years of age and older who live in a LF endemic area of PNG. Subject selection will not be based on health status. The study aims to determine the relative impact and cost effectiveness of annual versus twice yearly MDA (DEC 6 mg/kg body plus Alb 400 mg for all individuals) for elimination of LF and reduction in soil transmitted helminthic infection burdens in these populations.
The project is comprised of repeated annual cross-sectional surveys in sentinel communities before and after initiation of MDA for LF. The surveys will be conducted over a period of 3 years at the following times: 0 (pre-treatment baseline), 1, 2, and 3 years corresponding to annual treatment times. Government health officials as part of the GPELF will administer the MDA (standard regimen recommended by WHO is DEC + ALB). Part of the government-sponsored program will be to screen for LF using ICT card screening and finger stick bloods for measuring the density of blood born microfilaria (MF). The current protocol will assist in collection of these data. As part of the annual treatment infection surveillance the study team will also collect demographic data, history of lymphedema, scrotal swelling (hydrocele), acute filarial fever or adenolymphangitis, and history of prior treatment for LF.
|Study Type :||Observational|
|Actual Enrollment :||3200 participants|
|Official Title:||Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis: Monitoring Efficacy of Ongoing Treatment Programs in Papua New Guinea|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given twice per year
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once per year
- The comparator (standard treatment) DEC 6mg/kg + Alb 400mg administered annually (at 0, 12 and 24 months). [ Time Frame: 36 months ]Determine if administering DEC 6 mg/kg + ALB 400 mg given twice per year is more effective than standard DEC 6 mg/kg + Alb 400 mg given once per year in achieving reduction of microfilarial prevalence caused by Wuchereria bancrofti infection to less than 1% at 36 months after the initiation of the study.
- DEC 6mg/kg + Alb 400 given once [ Time Frame: 36 months ]We will test the hypothesis that twice annual MDA is superior to annual MDA for achieving a significantly greater reduction in prevalence and intensity of infection of STH infection infections at 36 months after the initiation of the study
- DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month). [ Time Frame: 36 months ]We will test the hypothesis that twice annual MDA is more cost effective compared to annual MDA for eliminating LF at 36 months.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268252
|Papua New Guinea|
|Papua New Guinean Institute for Medical Research|
|Maprik, West Sepik, Papua New Guinea|
|Principal Investigator:||James W Kazura, MD||Case Western Reserve University|
|Principal Investigator:||Christopher L King, MD, PhD||Case Western Reserve University|
|Principal Investigator:||Peter M Siba, PhD||Papua New Guinea Institute of Medical Research|