CompletedNot Applicable

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

Haiti, India, Indonesia23,789 participantsStarted 2016-07

Plain-language summary

The DOLF Triple Drug Therapy for Lymphatic Filariasis study will determine the frequency, type and severity of adverse events following triple-drug therapy (IVM+DEC+ALB, IDA) compared to the standard two-drug treatment (DEC+ALB, DA) in infected and uninfected individuals in a community in 5 different countries. The objective is to acquire safety, efficacy, and acceptability data to assess the safety and acceptability of the IDA drug combination.

Who can participate

Age range2 Years

SexALL

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Inclusion criteria

✓. Age ≥ 5 years, male or female for IDA arm and age \> 2 years for DA arm.
✓. Able to provide informed consent to participate in the trial (forms to be attached)
✓. No evidence of severe or systemic co-morbidities except for features of filarial disease

Exclusion criteria

✕. Age \< 5 years (ivermectin is contraindicated in children below 5 years of age) for IDA arm and age \< 2 years for DA arm
✕. Pregnant women (DEC, ivermectin and albendazole are contraindicated in pregnancy)
✕. Severe chronic illness (for example, chronic renal failure, inability to care for oneself with activities of daily living)
✕. History of previous allergy to MDA drugs
✕. Age ≥ 5 years, for IDA and DA arms (males and females).
✕. Able to provide informed consent or give parental consent for minors to participate in the trial
✕. No evidence of severe or systemic co-morbidities except for features of filarial disease
✕. Age \< 5 years (ivermectin is not approved for use in children less than 5 years of age)

What they're measuring

Number of participants with treatment-related adverse events as assessed by modified CTCAE v4.0 scale

Timeframe: within 7 days of drug administration

Trial details

NCT IDNCT02899936

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04-27

View on ClinicalTrials.gov More Lymphatic Filariasis trials