Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Proportion of patients recovered from arthritis
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at regular intervals until 6 months. The main outcome measure is recovery from arthritis, and secondary outcome measures include swollen and tender joint counts, Ritchie index, joint pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will also address the safety and tolerability of long-term antibiotic treatment. 56 patients are enrolled and the enrollment of patients has been completed.
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
- Triple (Participant, 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
- •Diagnosis of acute reactive arthritis
- •Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months
- •Age 18 or older
排除标准
- •Allergy to quinolones or macrolides
- •Treatment with systemic corticosteroids within 2 weeks
- •Serum creatinine level elevated over the reference limit
- •Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit
- •Current or planned pregnancy, or lack of contraception
- •Known HIV positivity
- •Blood leukocyte count less than 4.0x109/l
- •Blood platelet count less than 100x109/l
- •Lack of co-operation.
研究组 & 干预措施
1
ofloxacin and roxithromycin
干预措施: ofloxacin and roxithromycin (Drug)
2
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of patients recovered from arthritis
时间窗: 6 months
次要结局
- Tender joint count(6 months)
- Ritchie index(6 months)
- Swollen joint count(6 months)
- Joint pain (visual analogue scale)(6 months)
- Serum C-reactive protein level(6 months)
- Blood erythrocyte sedimentation rate(6 months)