NCT01905436

Brief Summary

Approximately 5,200 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis and onchocerciasis endemic areas. Subject selection will not be based on health status. Two sites will be studied, and each study will last for 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. Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these MDA schedules on soil transmitted helminth infections. MDA will be administered by others (Liberian Ministry of Health or Liberian Institute of Biomedical Research). The investigators will test the hypothesis that semiannual mass drug administration (MDA) is superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for control of soil transmitted helminth (STH) infections.

  1. 1.Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.
  2. 2.Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations.
  3. 3.Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,862

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

5.1 years

First QC Date

July 12, 2013

Last Update Submit

February 10, 2022

Conditions

Lymphatic FilariasisOnchocerciasisSoil Transmitted Helminth (STH) Infections

Keywords

FilariasisOnchocerciasisAlbendazoleIvermectinSTH Soil Transmitted Helminth infectionsMDA Mass Drug Administration

Outcome Measures

Primary Outcomes (2)

  • Prevalence of W. bancrofti microfilaria (4 years)

    Prevalence of W. bancrofti microfilaria (mf) is a binary outcome measured by the presence/absence of W. bancrofti mf in three-line thick smears prepared with a measured 60 microliter quantity of finger prick blood collected between 8pm-2am. The species of mf will be determined by morphological criteria.

    4 years

  • Prevalence of W. bancrofti filarial antigenemia (4 years)

    Prevalence of this outcome measure is determined by the percentage (%) of individuals with positive tests for the W. bancrofti filarial antigen. Blood will be tested for filarial antigenemia using the Alere Filariasis Test Strip (FTS).

    4 years

Secondary Outcomes (6)

  • Prevalence of O. volvulus microfilaria (4 years)

    4 years

  • Community egg load of soil transmitted helminth (STH) eggs (4 years)

    4 years

  • Prevalence of W. bancrofti microfilaria (7 years)

    7 years

  • Prevalence of W. bancrofti filarial antigenemia (7 years)

    7 years

  • Prevalence of O. volvulus microfilaria (7 years)

    7 years

  • +1 more secondary outcomes

Study Arms (2)

Annual Mass Drug Administration

This group will receive annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Liberian Ministry of Health.

Drug: Annual versus Semiannual Albendazole plus Ivermectin Mass Drug Administration

Semiannual Mass Drug Administration

This group will receive semi-annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Liberian Ministry of Health.

Drug: Annual versus Semiannual Albendazole plus Ivermectin Mass Drug Administration

Interventions

Annual versus Semiannual Albendazole plus Ivermectin Mass Drug AdministrationDRUG

Annual or semiannual Albendazole plus Ivermectin, administered by the Liberian Ministry of Health.

Also known as: Albenza (Albendazole); Ivermectin, also known as Mectizan or Stromectol.
Annual Mass Drug AdministrationSemiannual Mass Drug Administration

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study populations are people who live in areas of Liberia that are co-endemic for lymphatic filariasis and onchocerciasis.

You may qualify if:

  • Study areas should be endemic for filariasis and onchocerciasis.
  • Study population have limited or no prior experience with MDA. Males and Females greater than 5 years of age.

You may not qualify if:

  • Children less than 5 years of age.
  • Children who weigh less than 15 kg (33 lb)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liberian Institute of Biomedical Research

Charlesville, Margibi County, Liberia

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Study procedures include collection of finger prick blood that will be tested for microfilaremia and for serology testing (antigenemia and antibody testing). Investigators will also collect skin snips (small superficial skin biopsies) to detect Onchocerca microfilariae, and stool samples to detect parasitic worm eggs indicative of STH infections. All assays will be performed in Liberia (filarial serology tests, MF smears, stool examinations).

MeSH Terms

Conditions

Elephantiasis, FilarialOnchocerciasisInfectionsFilariasis

Interventions

AlbendazoleIvermectin

Condition Hierarchy (Ancestors)

Spirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesMosquito-Borne DiseasesVector Borne DiseasesLymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, ParasiticSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesPolyketidesLactones

Study Officials

  • Gary J Weil, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Peter U Fischer, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Fatorma K Bolay, PhD

    Liberian Institute of Biomedical Research

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 23, 2013

Study Start

March 1, 2012

Primary Completion

April 1, 2017

Study Completion

July 1, 2021

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations

LI(1)