A Monocenter, Randomized, Double Blind Pilot Study Comparing Doxycycline in Combination With Hydroxychloroquine Treatment Versus Doxycycline Monotherapy in Patients With Long-Term Complaints Attributed to Lyme Borreliosis.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Health-related quality of life.
研究概览
简要总结
The goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults. The main questions it aims to answer are:
Does addition of hydroxychloroquine reduce physical complaints? Researchers will compare hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if hydroxychloroquine works to treat Lyme borreliosis.
Participants will:
Take hydroxychloroquine or a placebo two times a day during 28 days. Visit the clinic 4 times in one year for checkups and tests.
详细描述
Rationale Assess other strategies for Lyme patients with vexing symptoms.
Objective Provide initial insights as to whether addition of hydroxychloroquine results in reduction of physical complaints and assessing safety and tolerability of hydroxychloroquine in these patients.
Main trial endpoints The primary endpoint is health-related quality of life, as measured by the global score of the 36-item Short-form General Health Survey (SF-36) at EOT (week 4).
Secondary trial endpoints Secondary endpoints are improvement on subscales of SF-36 (pain and physical function) at week 4, safety at week 4 and 12 and global physical health composite score of the 36-item Short-form General Health Survey (SF-36) at week 52. Of note, there are no biochemical or microbiological test available to assess cure.
Trial design This is a monocentre, randomized, double blind pilot study. Treatment last one month, with a follow up at week 52. In total the subject are participating for one year.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 18 years of age or older
- •Patients with probable or possible signs and symptoms attributed to Lyme borreliosis
- •Patients with probable or possible post Lyme treatment Lyme borreliosis syndrome (PTLBS)
- •Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).
排除标准
- •Known contra-indication for used study medication.
- •Women who are pregnant or lactating
研究组 & 干预措施
Doxycycline in combination with Hydroxychloroquine
Doxycycline (standard of care) in combination with Hydroxychloroquine 2 x 200 mg (two times a day one tablet).
干预措施: Hydroxychloroquin (Drug)
Doxycycline in combination with Hydroxychloroquine
Doxycycline (standard of care) in combination with Hydroxychloroquine 2 x 200 mg (two times a day one tablet).
干预措施: Doxycycline (Drug)
Doxycycline in combination with placebo
Doxycycline (standard of care) in combination with Placebo (two times a day one tablet).
干预措施: Placebo (Drug)
Doxycycline in combination with placebo
Doxycycline (standard of care) in combination with Placebo (two times a day one tablet).
干预措施: Doxycycline (Drug)
结局指标
主要结局
Health-related quality of life.
时间窗: Week 4
Global physical health composite score of the 36-item Short-form General Health Survey (SF-36). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. Higher scores indicating better health and lower scores indicating worse health or disability
次要结局
- Safety of the study medication(Week 4 and week 12)
- Tolerability of the study medication(Week 4 and week 12)
- Health-related quality of life(Week 52)