Evaluating Levamisole for Treating Loiasis Infections
Randomized, Double-blind Trial Evaluating the Safety and Efficacy of a 3- or 5- Day Course of Levamisole 2.5 mg/kg in Subjects With Loa Loa Microfilaremia
This study tests if a medication called levamisole can help people with loiasis infections feel better by reducing the number of parasites in their blood over a few days.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Programme National de Lutte contre l'Onchocercose, Republic of the Congo Government |
| Locations | 2 sites (Sibiti, Komono and 1 other locations) |
| Trial ID | NCT06252961 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of levamisole administered over 3 and 5 days for managing loiasis microfilaremia in infected individuals. The study focuses on patients carrying L. loa microfilaremia, a condition prevalent in Central Africa, and seeks to determine if longer treatment regimens can effectively reduce microfilarial density while maintaining an acceptable safety profile. Participants will receive either levamisole or a placebo, and their health will be monitored throughout the trial to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 who are carriers of L. loa microfilaremia and meet specific weight and health criteria.
Not a fit: Patients with acute or chronic infections, recent vaccinations, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer alternative for managing loiasis and contribute to the elimination of onchocerciasis in co-endemic regions.
How similar studies have performed: Previous studies have shown the safety of single doses of levamisole, but this approach of longer treatment regimens is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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, as determined by history during the medical interview * Any condition, in the opinion of the investigator, that exposes the subject to undue risk * Known intolerance to levamisole * Subjects who donated blood in the previous 8 weeks to study entry, with a standard volume (\> 500 mL) * On clinical examination: symptoms, physical signs or laboratory findings suggestive of systemic disorders, including disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other abnormalities that could interfere with the interpretation of trial results. The physician may then give a favorable or unfavorable opinion on the participant's inclusion. * Ivermectin and/or levamisole taken in the last six months; and/or mebendazole or albendazole taken in the last month * Pregnant and/or breast-feeding women
Where this trial is running
Sibiti, Komono and 1 other locations
- Supervisor — Sibiti, Komono, Republic of the Congo (Recruiting)
- General Supervisor — Sibiti, Mokassi, Republic of the Congo (Recruiting)
Study contacts
- Principal investigator: François MISSAMOU, MD — Programme National de Lutte contre l'Onchocercose (PNLO)
- Study coordinator: Jéremy CAMPILLO, PharmD PhD
- Email: jeremy.campillo@ird.fr
- Phone: +33 4 67 41 61 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.