An Assessor Blind, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- cure d14
研究概览
简要总结
The main objective of this study is to provide data on the efficacy profile of different doses of oxfendazole when used in Trichuris trichiura infection. The drug will be also be examined for efficacy against other common nematodes encountered in man (Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus). The study will also provide data on the safety and tolerability of the oxfendazole in patients.
详细描述
This is an assessor blind, randomized, comparative study in adult patients with proven intestinal infection with Trichuris trichiura to be conducted as a field study. Patients meeting the study entry criteria will receive either 6 mg/kg or 15 mg/kg or 30 mg/kg of oxfendazole as a single oral dose, three single doses of oxfendazole on consecutive days, or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined prior to treatment and at 7, 14 and 21 days after treatment.
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)
盲法说明
Each patient's treatment condition will be masked by a code assigned at randomization. The study pharmacist will know this assignment. A person other than the investigator will administer the drug as directed by the pharmacists.
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
- •Male or female outpatient, more than 18 years and less than 65 years of age.
- •Written or witnessed oral informed consent has been obtained.
- •Trichuris trichiura demonstrated in stool samples obtained during the week before enrolment: The presence of Ascaris lumbricoides, Necator americanus, Ancylostoma duodenalis or other helminths will not be a cause for exclusion.
- •Willingness to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14 and 21 days after treatment.
- •Female patients of child bearing potential, who are using an established method of birth control (surgically sterile, intra-uterine contraceptive device, oral contraceptives, diaphragm in combination with contraceptive cream or foam, or condom in combination with contraceptive cream or foam) may be included
排除标准
- •The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
- •Presence of other helminths without Trichuris trichiura. Non-target species may be present and details of response will be recorded.
- •The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
- •The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
- •The patient has received an investigational drug within 30 days or 5 half-lives (whichever is longer) of the screening visit or is scheduled to receive such a drug during the study period.
- •The patient has a concomitant infection or any other underlying disease that would compromise the diagnosis and the evaluation of the response to the study medication.
- •The patient has a known history of renal dysfunction or plasma creatinine ≥ 1.5 times upper limit of normal for age or a known history of hepatic dysfunction or liver enzymes ≥ 1.5 times upper limit of normal.
- •The patient is a female who is pregnant, lactating or planning a pregnancy during the study, or is not practicing any form of contraception (see inclusion criteria (4.2.5).
- •The patient is unwilling or unable to take part in this study.
- •The patient has previously been enrolled in the study.
研究组 & 干预措施
OXF6
Patients receive a single 6 mg/kg dose of oxfendazole administered orally.
干预措施: Oxfendazole (Drug)
OXF15
Patients receive a single 15 mg/kg dose of oxfendazole administered orally.
干预措施: Oxfendazole (Drug)
OXF30
Patients receive a single 30 mg/kg dose of oxfendazole administered orally.
干预措施: Oxfendazole (Drug)
OXF15x3
Patients receive a 15 mg/kg dose of oxfendazole administered orally once a day for each of three consecutive days.
干预措施: Oxfendazole (Drug)
ALB400
Patients receive a single 400 mg/kg dose of albendazole administered orally.
干预措施: Albendazole (Drug)
结局指标
主要结局
cure d14
时间窗: Day 14 of follow up
absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
cure d7
时间窗: Day 7 of follow up
absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
次要结局
- improvement d21(Day 21 of follow up)
- improvement d14(Day 14 of follow up)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7(Day 7 of follow up)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14(Day 14 of follow up)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21(Day 21 of follow up)