跳至主要内容
临床试验/NCT04049630
NCT04049630已完成2 期

Randomized Clinical Trial, Double-blind, Dose-escalating of Drug Intensities, Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients

Programme National de Lutte contre l'Onchocercose, Republic of the Congo1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2021年1月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
255
试验地点
1
主要终点
Safety and tolerability of levamisole

研究概览

简要总结

This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection.

详细描述

This clinical trial will be conducted in Republic of Congo. This is a pragmatic and adaptative randomized, double-blind clinical trial. Levamisole will be tested at 1 and 1,5 mg/kg, and compared to placebo (36:36:36); or 2,5 mg/kg compared to placebo (36:36) in case of adaptation of the dose for cohorts II and III.

We will perform three cohorts of patients according to the microfilarial density : 1-1,999 mf/ml, 1-14,999 mf/ml, and all microfilaremic individuals; in order to respect the safety potentially related to loiasis.

The first cohort was to evaluate the most appropriate dose of levamisole, with a possibility to increase (to 2.5 mg/kg) the dose of levamisole for the cohorts II and III in case of lack of efficacy and in case of good safety profil.

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

入选标准

  • 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

排除标准

  • 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 preceding the administration of the treatment of the test determined by the anamnesis during the medical interview
  • Any condition, in the opinion of the investigator, which exposes the subject to an undue risk
  • Known intolerance to levamisole
  • Subjects who gave blood in the 8 weeks before entry into the study, with a standard volume (> 500 mL)
  • During the clinical examination: symptoms, physical signs or biological constants suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric disorders and other abnormalities likely to interfere with the interpretation results of the test. The doctor may then give a favorable or unfavorable opinion for the inclusion of the participant
  • Taking IVM and / or LEV during the last six months; and / or mebendazole or albendazole in the last month
  • Pregnant and lactating women (based on self-declaration)

研究组 & 干预措施

LEV 1 mg/kg

Experimental

Tablets of LEV at 1 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.

干预措施: LEV 1 mg/kg (Drug)

LEV 1 mg/kg

Experimental

Tablets of LEV at 1 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.

干预措施: Placebo (Drug)

LEV 1,5 mg/kg

Experimental

Tablet of LEV at 1,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.

干预措施: LEV 1,5 mg/kg (Drug)

LEV 1,5 mg/kg

Experimental

Tablet of LEV at 1,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.

干预措施: Placebo (Drug)

LEV 2,5 mg/kg

Experimental

Tablet of LEV at 2,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.

干预措施: LEV 2,5 mg/kg (Drug)

LEV 2,5 mg/kg

Experimental

Tablet of LEV at 2,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

Tablets of placebo will be administrated to the participant in single dose only one time.

干预措施: Placebo (Drug)

结局指标

主要结局

Safety and tolerability of levamisole

时间窗: 1 week

Absence of severe adverse events during the first week

Incidence of adverse events with levamisole

时间窗: 1 week

Proportion of adverse events during the first week

次要结局

  • Efficacy of levamisole(Day 2, Day 7, and Month 1)
  • Proportion of individuals without microfilariae of Loa loa(Day 7 and 1 Month)

研究者

发起方
Programme National de Lutte contre l'Onchocercose, Republic of the Congo
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验