Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Triple Drug Therapy for Lymphatic Filariasis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02899936
• Date of registration: 22/08/2016
• Prospective Registration: No
• Primary sponsor: Washington University School of Medicine
• Public title: Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Triple Drug Therapy for Lymphatic Filariasis
• Scientific title: Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) Versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis
• Date of first enrolment: July 2016
• Target sample size: 23789
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02899936
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Haiti, India, Indonesia, Papua New Guinea

Contacts

• Name: Christopher King, MD PHD
• Affiliation: Case Western Reserve University

• Name: Gary Weil, MD
• Affiliation: Washington University School of Medicine

Key inclusion & exclusion criteria

In India:

Inclusion Criteria:

1. Age = 5 years, male or female for IDA arm and age > 2 years for DA arm.

2. Able to provide informed consent to participate in the trial (forms to be attached)

3. No evidence of severe or systemic co-morbidities except for features of filarial
disease

Exclusion Criteria:

1. Age < 5 years (ivermectin is contraindicated in children below 5 years of age) for IDA
arm and age < 2 years for DA arm

2. Pregnant women (DEC, ivermectin and albendazole are contraindicated in pregnancy)

3. Severe chronic illness (for example, chronic renal failure, inability to care for
oneself with activities of daily living)

4. History of previous allergy to MDA drugs

For rest of countries:

Inclusion Criteria:

1. Age = 5 years, for IDA and DA arms (males and females).

2. Able to provide informed consent or give parental consent for minors to participate in
the trial

3. No evidence of severe or systemic co-morbidities except for features of filarial
disease

Exclusion Criteria:

1. Age < 5 years (ivermectin is not approved for use in children less than 5 years of
age)

2. Unable to provide informed consent or give parental consent for minors to participate
in the trial

3. Pregnant women (DEC, ivermectin and albendazole are not known to be safe for use
during pregnancy)

4. Severe chronic illness (chronic renal insufficiency, severe chronic liver disease, or
any illness that is severe enough to interfere with activities of daily living)

5. History of previous allergy to MDA drugs



Age minimum: 2 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lymphatic Filariasis

Intervention(s)

Drug: 3 drug dose - IDA

Drug: 2 drug dose - DA

Primary Outcome(s)

Number of participants with treatment-related adverse events as assessed by modified CTCAE v4.0 scale [Time Frame: within 7 days of drug administration]

Secondary Outcome(s)

Community acceptance will be measured using on a survey using likert scale questions based on perception of efficacy, intent to participate and relevance of the treatment. [Time Frame: 6-8 months]

Number of participants with clearance of microfilaremia (MF) as measured with microfilaremia night blood smear testing (finger prick - 60ul) [Time Frame: baseline (pre-treatment), within 7 days of drug administration and follow up at 12 months]

Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR at baseline and 12 months after treatment [Time Frame: Stool collected at baseline (pre-treatment), 4 weeks (individual response), and 12 months (community prevalence).]

Number of participants Filarial Test Strip (FTS) and/or MF positive as tested with FTS and night blood smears with treatment-related adverse events as assessed by modified CTCAE v4.0 scale [Time Frame: baseline (pre-treatment), within 7 days of drug administration and follow up at 12 months]

Secondary ID(s)

201607068

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Case Western Reserve University

Indian Council of Medical Research