Clinical Trial Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients (NCT04049630) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients
Republic of the Congo255 participantsStarted 2021-01-16
Plain-language summary
This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Written consent written, signed (or with thumbprint) and dated
* Aged 18 to 65 inclusive
* Individual microfilarial density ≥ 1mf/mL
* Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 85 kg
* In good health condition, as determined by the medical questionnaire and the general clinical examination: absence of acute or chronic infection
Exclusion Criteria:
* Participation in any study other than purely observational, in the 4 weeks preceding this study (determined by the theoretical date of administration of LEV or placebo).
* Any vaccination in the 4 weeks preceding this study.
* Acute infection requiring a treatment in the 10 days preceding this study, determined by the anamnesis during the medical interview (example: pulmonary infection, ENT, digestive, cutaneous, with implementation of an antibiotic treatment or not)
* Warfarin treatment
* Treatment with clozapine, phenythiazines, sulfasalazine, carbamazepine, synthetic antithyroid, ticlopidine, cimetidine, and gold salts: whether it is a long-term treatment, or a treatment given in a single dose 10 days before the start of treatment for the clinical trial (precaution of use compared to the risk of agranulocytosis of immuno-allergic or toxic origin)
* Known immunosuppressive pathology
* Past or current history of neurological (including epilepsy) or neuropsychiatric disease
* History of agranulocytosis
* Consumption of alcohol, taking cocaine or other drugs of abuse in the 72 hours pre…
What they're measuring
1
Safety and tolerability of levamisole
Timeframe: 1 week
2
Incidence of adverse events with levamisole
Timeframe: 1 week
Trial details
NCT IDNCT04049630
SponsorProgramme National de Lutte contre l'Onchocercose, Republic of the Congo