A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects (NCT06252961) | Clinical Trial Compass
RecruitingPhase 2/3
A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects
Republic of the Congo99 participantsStarted 2024-06-21
Plain-language summary
The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Consent informed, written, signed and dated
* Women or men aged 18 to 65 years inclusive
* Carrier of L. loa microfilaremia
* Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 90 kg
* In good health, as determined by medical questionnaire and general clinical examination
* Absence of acute or chronic infection :
Exclusion criteria
* Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of the first administration of levamisole or placebo)
* Any vaccination within 4 weeks previous to this study
* Infection requiring treatment in the 10 days previous to this study, as determined by the anamnesis during the medical interview (e.g. pulmonary infection , digestive or skin infection; with or without antibiotic treatment)
* Treatment with clozapine, phenothiazines, sulfasalazine, carbamazepine, synthetic antithyroid drugs, ticlopidine, cimetidine, and gold salts: whether it was long-term treatment, or treatment given as a single dose 10 days before the start of treatment for the clinical trial (precaution with regard to the risk of agranulocytosis of immuno-allergic or toxic origin)
* Known immunosuppressive pathology (by self-report)
* Past or present history of neurological (including epilepsy) or neuropsychiatric disease
* History of agranulocytosis
* Use of cocaine or other drugs of abuse in the 72 hours preceding administration of the trial treatment, …
What they're measuring
1
Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia
Timeframe: During the treatment (5 days) and 2 weeks after
Trial details
NCT IDNCT06252961
SponsorProgramme National de Lutte contre l'Onchocercose, Republic of the Congo