NCT03177993: FIT

Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji

Completed NA Last updated 31 December 2020

What this trial tests

NA trial testing 3 drug dose - IDA in Lymphatic Filariases in 4,773 participants. Completed in 24 October 2019.

Timeline

13 July 2017

Primary endpoint
22 November 2017

24 October 2019

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4,773
Start date	13 July 2017
Primary completion	22 November 2017
Estimated completion	24 October 2019
Sites	1 location across Fiji

Drugs / interventions tested

• 3 drug dose - IDA — full drug profile →
• 3 drug dose - IDA with second dose of ivermectin — full drug profile →
• 2 drug dose - DA — full drug profile →

Conditions studied

• Lymphatic Filariases — all drugs for Lymphatic Filariases →
• Scabies — all drugs for Scabies →
• Impetigo — all drugs for Impetigo →
• Soil Transmitted Helminths — all drugs for Soil Transmitted Helminths →

Sponsor

Washington University School of Medicine

Who can join

Eligibility, any sex, with Lymphatic Filariases or Scabies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The safety of combined triple drug therapy with ivermectin, diethylcarbamazine and albendazole in the neglected tropical diseases co-endemic setting of Fiji: A cluster randomised trial.
   Hardy M, Samuela J, Kama M, Tuicakau M, et al · · 2020 · cited 17× · PMID 32176703 · DOI 10.1371/journal.pntd.0008106
2. Individual Efficacy and Community Impact of Ivermectin, Diethylcarbamazine, and Albendazole Mass Drug Administration for Lymphatic Filariasis Control in Fiji: A Cluster Randomized Trial.
   Hardy M, Samuela J, Kama M, Tuicakau M, et al · · 2021 · cited 16× · PMID 33728462 · DOI 10.1093/cid/ciab202
3. Community control strategies for scabies: A cluster randomised noninferiority trial.
   Hardy M, Samuela J, Kama M, Tuicakau M, et al · · 2021 · cited 13× · PMID 34758017 · DOI 10.1371/journal.pmed.1003849