Optimization of MDA With Existing Drug Regimens for LF: Monitoring Efficacy of Ongoing Treatment Programs in PNG

NCT03268252 | Completed DMC

• 1 other identifier: CWRU Optimization MDA LF PNG
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief Summary

The standard regimen for elimination of lymphatic filariasis (LF) in PNG is annual administration of two drugs at the same time. The two drugs are called "DEC" (Diethylcarbamazine, 6 mg/kg body weight) and "ALB" (Albendazole 400 mg for all individuals regardless of weight), which are given one time per year for five to seven years with the aim to interrupt transmission that occurs through local mosquito vectors. These drugs kill the larval forms of the parasite in the blood that are necessary for continuing transmission of infection by the mosquito vector. The two drugs were previously thought to have little effect on adult worms, the stage of the parasite which is responsible for production of the larval forms that appear in the blood of infected people. Recent data, however, suggest that DEC and ALB can kill or render adult worms unable to produce the larval forms (sterilization). Therefore, giving these drugs twice per year for three consecutive years may increase the rate of killing or sterilizing of adults worms over regimens that involve administration of the same drugs only one time per year. The overall goal of this research is to compare the anti-parasite activity of DEC plus ALB given one time per year, the current standard for MDA to eliminate LF, to DEC plus ALB given two times per year (at 6-month intervals) in order to reduce the total duration and cost of MDA to eliminate LF in PNG. Adults (18 years and older) and minors (age 5 to 17 years) will be invited to participate in this study. Study participants will be asked to give finger stick blood samples to check LF infection status and stool samples to determine how well the drugs eliminate intestinal worm infections. Sampling will be done by repeated cross-sectional surveys in the same communities, but not necessarily the same persons, one time per year over a 3-year period. As part of the annual treatment infection surveillance the study team will also collect demographic data (place of residence, family relationship, age, use of bed nets), history of swelling of the arms and legs (elephantiasis), scrotal swelling (hydrocele), acute filarial fever accompanied by extremity swelling, and history of prior treatment for LF.

Conditions

Lymphatic Filariasis

Outcome Measures

Primary Outcomes (1)

• The comparator (standard treatment) DEC 6mg/kg + Alb 400mg administered annually (at 0, 12 and 24 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 Outcomes (2)

• DEC 6mg/kg + Alb 400 given once

  36 months

• DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month).

  36 months

Study Arms (2)

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

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• \. Not willing or able to give informed consent for the study

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Papua New Guinea Institute of Medical Research: collaborator

Study Sites (1)

Papua New Guinean Institute for Medical Research

Maprik, Sandaun Province, Papua New Guinea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Any remaining from the finger stick/stool samples will be cryopreserved for subsequent testing for presence of other infections that have public health importance in PNG (e.g., malaria) using molecular or serological assays. Genetic testing of samples for the LF, malaria or common blood borne or intestinal infections will be performed using microsatellite markers or highly polymorphic genes as confirmatory diagnostic tests and/or to assess the diversity of the parasite populations in the communities.

MeSH Terms

Conditions

Elephantiasis, Filarial

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: August 31, 2017
• Study Start: June 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

PA (1)