Clinical trial NCT03177993: Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
Official title: Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) Versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphatic Filariases
Scabies
Impetigo
Soil Transmitted Helminths
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Task Force for Global Health
name: Murdoch Childrens Research Institute
First posted: 2017-06-06
Enrollment: 4773
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lymphatic Filariasis (LF), scabies and soil transmitted helminths (STH) are common neglected tropical diseases affecting the people of Fiji. There is a dedicated LF eradication program supported by the World Health Organization (WHO), however scabies and STH are currently managed on an individual level with symptomatic treatment as required.

In an attempt to reduce the prevalence of LF globally, research is being undertaken into alternative, more effective treatment options. A recent study in Papua New Guinea demonstrated a new triple drug therapy (ivermectin, diethylcarbamazine and albendazole) is superior to the currently recommended two drug therapy (diethylcarbamazine and albendazole) used by WHO LF programs in the Pacific. However, adverse events were more frequent. Despite no serious adverse events being observed, it is necessary to conduct further studies to review the safety of this new triple therapy before it can be endorsed as an effective mass drug administration (MDA) regimen for LF in endemic countries. Fiji's burden of LF, that has been recalcitrant to previous MDA with diethylcarbamazine and albendazole, make it an ideal site to obtain further efficacy and safety data of the triple therapy.

Ivermectin given to communities as MDA has been proven to be effective in reducing the community prevalence of scabies. What is not known is the effects of one dose versus two doses of ivermectin as MDA. This question will be reviewed within the design of the community randomized study. The prevalence of impetigo in a community is linked to scabies and this will also be reviewed. Ivermectin and albendazole are both effective individually against STH. The effectiveness of this combination of treatment as MDA in Fiji for STH has not been studied. The effectiveness for the individual in the short-term and the community in the longer-term will be reviewed.

In addition, the acceptability and feasibility of the new therapy in communities at risk of these three diseases will be reviewed.


Eligibility criteria: Inclusion Criteria:

* All community members that have given written informed consent to participate

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Frequency, type, and severity of adverse events reported by participants following treatment with triple drug therapy (IDA) and standard two drug therapy (DA) in LF infected and uninfected individuals in a community as measured by CTCAE v4.03
timeFrame: within 7 days of drug administration
Secondary outcomes:
measure: Clearance of microfilariae (mf) and filarial antigenemia following treatment with IDA or DA in LF infected individuals as measured by microfilaria count in 60ul thick blood smears and filarial test strip rapid diagnostic antigen test.
timeFrame: Baseline and 12 months
measure: Prevalence of scabies in study population measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
timeFrame: Baseline and 12 months
measure: Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR at baseline and 12 months after treatment
timeFrame: Stool collected at baseline (pre-treatment), 4 weeks (individual response), and 12 months (community prevalence).
measure: Acceptability and feasibility of IDA and DA in communities at risk of LF, scabies and STH as assessed by survey and focus group discussions.
timeFrame: Approximately 4 weeks following treatment
measure: Prevalence of impetigo measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Suva
country: Fiji
facility: Ministry of Health and Medical Services
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Andrew Steer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Gary Weil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Christopher King, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hardy M, Samuela J, Kama M, Tuicakau M, Romani L, Whitfeld MJ, King CL, Weil GJ, Schuster T, Grobler AC, Engelman D, Robinson LJ, Kaldor JM, Steer AC. Community control strategies for scabies: A cluster randomised noninferiority trial. PLoS Med. 2021 Nov 10;18(11):e1003849. doi: 10.1371/journal.pmed.1003849. eCollection 2021 Nov.
citation: Hardy M, Samuela J, Kama M, Tuicakau M, Romani L, Whitfeld MJ, King CL, Weil GJ, Grobler AC, Robinson LJ, Kaldor JM, Steer AC. Individual Efficacy and Community Impact of Ivermectin, Diethylcarbamazine, and Albendazole Mass Drug Administration for Lymphatic Filariasis Control in Fiji: A Cluster Randomized Trial. Clin Infect Dis. 2021 Sep 15;73(6):994-1002. doi: 10.1093/cid/ciab202.