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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia
研究概览
简要总结
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.
详细描述
Onchocerciasis and loiasis are parasitic diseases caused by Onchocerca volvulus and Loa loa, respectively.
Onchocerciasis is endemic in 31 African countries, parts of South America, and Yemen, affecting around 37 million people, while loiasis is present in Central Africa, infecting approximately 15 million individuals. Both diseases are associated with severe complications and increased mortality.
African countries have implemented mass drug administration (MDA) programs using ivermectin to combat onchocerciasis. However, co-endemic loiasis poses challenges due to the risk of severe adverse events. Current strategies involve alternative treatments and chemoprophylaxis to accelerate onchocerciasis elimination. The project aims to evaluate the use of levamisole as an alternative treatment.
This project will assess the safety and efficacy of administering levamisole for 3 and 5 days to reduce Loa microfilarial density. Previous research demonstrated the safety of a single dose of levamisole but indicated the need for longer treatment regimens to achieve a significant reduction in Loa microfilarial density. The project aims to test whether 3- and 5-day levamisole regimens induce an acceptable safety profile and a stronger reduction in Loa microfilarial density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Levamisole 3 days
Participants randomized in this arm will receive 3 days of levamisole 2.5mg/kg, followed by 2 days of placebo
干预措施: Levamisole 3 days (Drug)
Levamisole 5 days
Participants randomized in this arm will receive a 5-day course of levamisole 2.5mg/kg
干预措施: Levamisole 5 days (Drug)
Placebo
Participants randomized in this arm will receive 5 days of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia
时间窗: During the treatment (5 days) and 2 weeks after
The proportions of adverse reactions and severe adverse reactions between the three arms of study will be compared, as well as between each interventional arm versus placebo, using appropriate comparative tests A multivariate analysis may be envisaged to assess the influence of age, gender and the presence or absence of M. perstans on the proportion of AEs
次要结局
- Efficacy of multiple doses of levamisole 2.5 mg/kg on Loa loa microfilaremia(From Day 3 after the first dose to Day 30 after the first dose)