- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03268252
Optimization of MDA With Existing Drug Regimens for LF: Monitoring Efficacy of Ongoing Treatment Programs in PNG (MDA)
Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis: Monitoring Efficacy of Ongoing Treatment Programs in Papua New Guinea
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
West Sepik
-
Maprik, West Sepik, Papua New Guinea
- Papua New Guinean Institute for Medical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study population (3,200/survey) will include male and female subjects >=5 years of age living in East Sepik Province, PNG. If unexpected logistical problems should arise, other study areas have been identified in Madang Province. The proposed study area will be in the Dreikikier Rural Local Level Government (LLG, approx pop 20,000) and Gawanga Rural, LLG (approx pop 13,000). Residents of villages previously treated with MDA will not be included in the study.
Children <5 years of age from community studies excluded because prevalence rates for LF tend to be very low in young children and because of difficulties associated with collecting clinical specimens from this population. Pregnancy will not be an exclusion criteria because DEC and ALB are considered safe in pregnancy.
Description
Inclusion Criteria:
- Individuals aged >=5 years of age in the community
- Willingness to give informed consent to participate in the study
- Willingness of parents or guardians to give consent for minors to participate in study
Exclusion Criteria:
1. Not willing or able to give informed consent for the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
2x/year MDA
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given twice per year
|
1x/year MDA
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once per year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
36 months
|
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.
|
36 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Peter M Siba, PhD, Papua New Guinea Institute of Medical Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CWRU Optimization MDA LF PNG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphatic Filariasis
-
University Hospitals Cleveland Medical CenterWashington University School of Medicine; Case Western Reserve University; Papua... and other collaboratorsRecruitingLymphatic Filariasis Elimination by Mass Drug Administration | Monitoring and Evaluation of Mass Drug Administration for Lymphatic Filariasis | Acceptability of Mass Drug Administration for Lymphatic FilariasisPapua New Guinea
-
Washington University School of MedicineIndonesia University; Case Western Reserve University; Ministere de la Sante... and other collaboratorsCompletedLymphatic FilariasesFiji, Haiti, India, Indonesia, Papua New Guinea
-
Washington University School of MedicineCase Western Reserve University; Regional Hospital of Agboville, Southern Cote...Active, not recruiting
-
University Hospitals Cleveland Medical CenterWashington University School of MedicineCompleted
-
National Institute of Allergy and Infectious Diseases...Completed
-
The Task Force for Global HealthUnited States Agency for International Development (USAID)CompletedLymphedema | Lymphatic Filariasis | FilariasisIndia
-
The Task Force for Global HealthUnited States Agency for International Development (USAID)CompletedLymphedema | Lymphatic Filariasis | FilariasisSri Lanka
-
University Hospitals Cleveland Medical CenterCompletedLymphatic FilariasisPapua New Guinea
-
Centre d'Appui à la lutte contre la MaladieWorld Health Organization; Malaria Research and Training Center, Bamako, MaliCompletedLymphatic Filariasis
-
Washington University School of MedicineDoris Duke Charitable Foundation; Centre for Research on Filariasis and other...Unknown