Better Options for Lymphatic Filariasis Treatment

Not Applicable

Not yet recruiting

• Conditions: Lymphatic Filariasis; Scabies; Strongyloidiasis
• Interventions: Drug: MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole; Drug: IDA - Ivermectin + DEC + albendazole

• Registration Number: NCT07159373
• Lead Sponsor: Medicines Development for Global Health

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2026-03-01
• Primary Completion: 2027-06
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5100

Inclusion Criteria

1. Provision of signed and dated informed consent.
2. 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:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MoxDA	MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole	Moxidectin + diethylcarbamazine + albendazole
IDA	IDA - Ivermectin + DEC + albendazole	Ivermectin + diethylcarbamazine + albendazole

Primary Outcome Measures

Name	Time	Method
Proportion of microfilariae (Mf)-positive participants at Baseline who are Mf-negative at Month 12 following treatment with MoxDA or IDA	12 months post-treatment	Lymphatic filariasis (LF) Mf measured by ultrafiltration
Incidence and severity of adverse events	7 days, 12 months and 24 months post-treatment	Frequency, type, and severity of adverse events reported by treatment group

Secondary Outcome Measures

Name	Time	Method
Proportion of Mf-positive participants at Baseline who are Mf-negative at Month 24 following treatment with MoxDA or IDA	24 months post-treatment	LF Mf measured using ultrafiltration
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	12 and 24 months post-treatment	LF Mf measured using ultrafiltration
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	12 and 24 months post-treatment	CFA measured using rapid lateral flow assay
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	12 and 24 months post-treatment	LF Mf measured using ultrafiltration
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	12 and 24 months post-treatment	CFA measured using rapid lateral flow assay
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	12 to 24 months post-treatment	LF Mf measured using ultrafiltration
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	12 to 24 months post-treatment	Lf Mf measured using ultrafiltration
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	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	12 and 24 months post-treatment	Scabies and impetigo measured using modified International Alliance for the Control of Scabies (IACS) criteria based on examination of normally exposed skin
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	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	12 and 24 months post-treatment	LF Mf measured using ultrafiltration and CFA measured using rapid lateral flow assay

Trial Locations

Locations (1)

Ministry of Health and Medical Services Fiji; 🇫🇯 Suva, Fiji