Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 476
- 试验地点
- 1
- 主要终点
- The primary end point was the fever clearance time
研究概览
简要总结
New antibiotics are required to have not only the antibacterial activity against doxycyline-resistant O. tsutsugamushi but also lower risk for resistance or any cross-resistance to others.
In this prospective, open-label, randomized trial, we enroll patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day rifampin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital, or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.
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
- None
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
- •Inclusion criteria were:
- •Adults aged 18 years or older
- •A fever of higher than 37.5°C
- •The concurrent presence of eschar or a maculopapular skin rash; and the clear presence of more than two symptoms such as headache, malaise, myalgia, coughing, nausea and abdominal discomfort.
- •Patients were hospitalized at Chosun University Hospital in Kwangju, Korea or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.
排除标准
- •The exclusion criteria were:
- •An inability to take oral medications
- •Pregnancy
- •Hypersensitivity to the trial drugs
- •Previous drug therapy with potential antirickettsial activity (e.g., rifampicin, chloramphenicol, macrolides, fluoroquinolones or tetracyclines) within 48 h prior to admission
- •Severe scrub typhus (shock requiring vasopressor therapy for more than one hour
- •A stuporous or comatose level of consciousness
- •Respiratory failure requiring mechanical ventilation or renal failure requiring immediate dialysis) (4, 10).
- •For the differential diagnosis of scrub typhus from other diseases with similar symptoms (e.g., murine typhus, leptospirosis, hemorrhagic fever with renal syndrome and systemic lupus erythematosus), patients underwent diagnostic tests. We thus excluded patients with concurrent infections who had the risk of causing different outcomes.
研究组 & 干预措施
1
a 5-day course of daily 200-mg doses of doxycycline
干预措施: doxycycline (Drug)
2
a 5-day course of daily 600-mg doses of rifampin
干预措施: rifampin (Drug)
结局指标
主要结局
The primary end point was the fever clearance time
时间窗: 4 years
次要结局
- The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse"(4 years)
研究者
Dong-Min Kim
Chosun University Hospital
Chosun University Hospital