Clinical Efficacy Analysis of Drug Use Tigecycline for Re-creation of Antimicrobial Agents for Treatment of Scrub Typhus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Defervescence
研究概览
简要总结
This multicenter, randomized, open-label clinical trial evaluated the efficacy and tolerability of intravenous tigecycline compared with oral doxycycline in adults hospitalized with scrub typhus. Participants were randomly assigned to receive either intravenous tigecycline or oral doxycycline. The primary efficacy outcome was time to defervescence, and tolerability was assessed based on reported adverse events.
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
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hospitalization with a fever of 37.5℃ or higher (tympanic temperature measurement standard) and rash or scabs suspected of tsutsugamushi syndrome
- •If an infectious disease specialist makes a clinical judgment and diagnoses scrub typhus
- •A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing a detailed explanation of this clinical study and fully understanding it
排除标准
- •Patients with severe complications such as respiratory failure, pneumonia, and encephalitis (researcher determines final exclusion)
- •Patients with chronic renal dysfunction
- •Underweight people weighing less than 45Kg
- •Immunodeficiency: Long-term use of steroids or other immunosuppressive drugs, patients undergoing chemotherapy, etc. (Researcher determines final exclusion)
- •Pregnant women
- •Women and men of childbearing potential who are planning to become pregnant during the clinical study period and for 3 months after the end of the clinical study, or who are unwilling to use the following appropriate contraceptive methods*
- •* Intrauterine device [IUD (Intrauterine device), barrier contraception method including spermicide (for female contraceptive vaginal diaphragm/vaginal sponge sponge/cervical cap) and double barrier method (for male use) Excluding simultaneous use of condoms and female condoms), sterilization (vasectomy, vasectomy, tubal ligation, etc.)
- •If you cannot take the medicine orally
- •Patients already using other anti-rickettsial drugs (rifampin, chloramphenicol, macrolides, quinolones, tetracyclines)
- •Patients with shock or multiple organ failure requiring vasopressor/vasoconstrictor, impaired consciousness, respiratory failure requiring mechanical ventilation, and renal dysfunction requiring hemodialysis
研究组 & 干预措施
Tigecycline
Participants receive intravenous tigecycline
干预措施: Tigecycline (Tygacil) (Drug)
Doxycycline
Participants receive oral doxycycline
干预措施: doxycycline (Drug)
结局指标
主要结局
Defervescence
时间窗: from treatment initiation to defervescence, assessed daily through Day 7
Time from treatment initiation to defervescence, defined as maintenance of body temperature below 37.3°C for at least 48 consecutive hours without antipyretics.
次要结局
- Treatment failure(up to 7 days after treatment initiation)
- Relapse(up to 30 days after treatment initiation)
- adverse events(up to 28 days after treatment initiation)
研究者
Jin Soo Lee
Professor
Inha University Hospital