Health Trials

Better Options for Lymphatic Filariasis Treatment

ConditionsLymphatic FilariasisScabiesStrongyloidiasis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMedicines Development for Global Health

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of signed and dated informed consent.

Resident in one of the study locations.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole

    Drug

    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% cream (unless allergic)

  • IDA - Ivermectin + DEC + albendazole

    Drug

    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% cream (unless allergic)

Treatment groups

5,100 Participants
are divided into 2 treatment groups
Group A: MoxDAExperimental treatment 1 intervention
Group B: IDAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of microfilariae (Mf)-positive participants at Baseline who are Mf-negative at Month 12 following treatment with MoxDA or IDA

Lymphatic filariasis (LF) Mf measured by ultrafiltration

Time frame
12 months post-treatment
2

Incidence and severity of adverse events

Frequency, type, and severity of adverse events reported by treatment group

Time frame
7 days, 12 months and 24 months post-treatment

Secondary outcomes

1

Proportion of Mf-positive participants at Baseline who are Mf-negative at Month 24 following treatment with MoxDA or IDA

LF Mf measured using ultrafiltration

Time frame
24 months post-treatment
2

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

LF Mf measured using ultrafiltration

Time frame
12 and 24 months post-treatment
3

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

CFA measured using rapid lateral flow assay

Time frame
12 and 24 months post-treatment
4

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

LF Mf measured using ultrafiltration

Time frame
12 and 24 months post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medicines Development for Global Health

Lead sponsor

Murdoch Childrens Research Institute

Collaborator

Kirby Institute

Collaborator

Source ClinicalTrials.gov

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