Better Options for Lymphatic Filariasis Treatment

Official title

Safety and Efficacy Trial of Mass Drug Administration With Moxidectin Versus Ivermectin in Combination With Diethylcarbamazine and Albendazole for Lymphatic Filariasis, Scabies, and Strongyloidiasis in Fiji

Overview

The goal of this clinical trial is to learn if mass drug administration with moxidectin in combination with diethylcarbamazine, and albendazole (MoxDA) can treat lymphatic filariasis, scabies and strongyloidiasis in children and adults living in communities where these diseases are common. The main questions it aims to answer are: 1. Does MoxDA clear infection in people with lymphatic filariasis ? 2. Does MoxDA cause any medical problems in infected and uninfected people? Researchers will compare MoxDA with ivermectin given together with diethylcarbamazine and albendazole (IDA) to see if it works better to clear infection and does not cause any more medical problems. Participants will: 1. Be tested to see if they are infected with the parasites that cause lymphatic filariasis, scabies and strongyloidiasis 2. Take 3 single doses of MoxDA or IDA, 12 months apart 3. Visit their village centre once or twice in the 1 week after each treatment for safety checkups

Interventions

• Drug MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole
  Mass drug administration with moxidectin co-administered with DEC and albendazole (MoxDA). Participants who are ineligible to receive moxidectin will be offered modified treatment options: 1. Children aged ≥ 2 years but \< 4 years - DEC, albendazole, and permethrin 5% cream 2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5% cr
• Drug IDA - Ivermectin + DEC + albendazole
  Mass drug administration with ivermectin co-administered with DEC and albendazole (IDA). Participants who are ineligible to receive moxidectin will be offered modified treatment options: 1. Children aged \< 2 years or weight \< 15 kg - DEC, albendazole, and permethrin 5% cream 2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5%

Primary outcome measures

• Proportion of microfilariae (Mf)-positive participants at Baseline who are Mf-negative at Month 12 following treatment with MoxDA or IDA [Time frame: 12 months post-treatment]
• Incidence and severity of adverse events [Time frame: 7 days, 12 months and 24 months post-treatment]

Secondary outcome measures (11)

• Proportion of Mf-positive participants at Baseline who are Mf-negative at Month 24 following treatment with MoxDA or IDA [Time frame: 24 months post-treatment]
• Mean Mf density and mean change from Baseline at Months 12 and 24 following treatment with MoxDA or IDA in participants who are Mf-positive at Baseline [Time frame: 12 and 24 months post-treatment]
• Proportion of participants who are circulating filarial antigen (CFA)-positive at baseline who become CFA-negative at Months 12 and/or 24 following treatment with MoxDA or IDA [Time frame: 12 and 24 months post-treatment]
• Change in community prevalence of LF, as measured by Mf, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24 [Time frame: 12 and 24 months post-treatment]
• Change in community prevalence of LF, as measured by CFA, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthl [Time frame: 12 and 24 months post-treatment]
• Proportion of participants with presence of Mf between Month 12 and Month 24 among those who were Mf positive at Month 12 following treatment with MoxDA or IDA [Time frame: 12 to 24 months post-treatment]
• Time to first detection of Mf in participants with presence of Mf between Month 12 and Month 24 among those who were Mf positive at Month 12 following treatment with MoxDA or IDA [Time frame: 12 to 24 months post-treatment]
• Community acceptability of MDA with MoxDA or IDA assessed by surveys, focus group discussions, and/or key informant interviews before Baseline and approximately 2 months following MDA at Baseline and Month 12 [Time frame: Pre- and post-treatment at Baseline and post-treatment at Month 12]
• Change in community prevalence of scabies and impetigo at Months 12 and 24 following annual community MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessment between Months 12 and 24 [Time frame: 12 and 24 months post-treatment]
• Change in community seroprevalence of S. stercoralis at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24 [Time frame: 12 and 24 months post-treatment]
• Change in community prevalence of LF, as measured by Mf and CFA, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24 [Time frame: 12 and 24 months post-treatment]

Eligibility criteria

Inclusion criteria

• Provision of signed and dated informed consent.
• Resident in one of the study locations.

Exclusion criteria

There are no exclusion criteria to participation in the study.

Treatment Exclusion Criteria:

Participants are ineligible to receive the treatment regimen allocated to their village if they meet any of the following criteria:

• Severe illness (any illness that is severe enough to interfere with activities of daily living);
• Known or suspected allergy to ivermectin, moxidectin, diethylcarbamazine or albendazole;
• Pregnant;
• Breastfeeding a baby within 7 days of birth;
• Age < 4 years for villages randomised to moxidectin, diethylcarbamazine, and albendazole (MoxDA); or
• Age < 2 years or weight < 15 kg for villages randomized to ivermectin, diethylcarbamazine and albendazole (IDA).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Fiji · 1 center

• Ministry of Health and Medical Services Fiji — Suva

Identifiers

NCT: NCT07159373 · MDGH-MOX-3003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗