Efficacy of Combination Therapy With Minocycline for Treatment of Stenotrophomonas Maltophilia Infections
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- mortality rate
研究概览
简要总结
The objective of the study is to evaluate the efficacy of minocycline for treatment Stenotrophomonas maltophilia infection. The hypothesis of study is the combination therapy with minocycline would be better than the monotherapy for treatment Stenotrophomonas maltophilia infection.
详细描述
- Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment.
- After patient or their relatives are appreciated to join this project, patients will be randomly allocated to either levofloxacin or cotrimoxazole plus placebo (monotherapy plus placebo) or levofloxacin or cotrimoxazole plus minocycline (combination therapy).
- Duration of treatment is determined by site and severity of infection, approximately 7-28 days.
- Sample size calculation, by two independent proportions formula, the investigators estimate the mortality rate about 54 % in monotherapy group and mortality rate about 27 % in combination therapy with minocycline group, with 2-sided 95% Confidence interval; therefore,51 persons are needed each group.
- The investigators estimate gather data about 112 persons. (56 participants with monotherapy and 56 participants with combination therapy (minocycline plus another antibiotic drug from intervention trial))
- The categorical variables are reported as frequencies and percentages, while continuous variables are reported as means ± standard deviations for normally distributed data and median ± range for non-normally distributed data. The data collected from patients are compared using Chi-square tests or Fisher's exact tests for categorical variables and using t-tests or Mann-Whitney U-tests for continuous variables.
- During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.
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
- Double (Participant, Investigator)
盲法说明
Double blind, Placebo Controlled
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The infection caused by Stenotrophomonas maltophilia
- •The duration of treatment approximately between 7-28 days
- •The patients can take minocycline capsule via oral or nasogastric tube feeding.
- •The patients are anticipated to live more than 48 hrs after participation.
- •In case of an antibiotic drug administration for treatment Stenotrophomonas maltophilia beforehand, it should not exceed 48 hrs.
- •All of participants should be willing to join this project.
排除标准
- •Pregnancy and lactation
- •The patients with active hepatitis
- •The patients with history of minocycline allergy
研究组 & 干预措施
Combination therapy with minocycline
Minocycline oral 50 mg per capsule
4 capsules oral stat then 2 capsules oral every 12 hours
duration 7-28 days
干预措施: Minocycline (Drug)
Combination therapy with minocycline
Minocycline oral 50 mg per capsule
4 capsules oral stat then 2 capsules oral every 12 hours
duration 7-28 days
干预措施: Levofloxacin or Cotrimoxazole (Drug)
Monotherapy plus placebo
Patients were treated Stenotrophomonas maltophilia infection with standard monotherapy either levofloxacin or Trimethoprim/sulfamethoxazole plus placebo
干预措施: Levofloxacin or Cotrimoxazole (Drug)
Monotherapy plus placebo
Patients were treated Stenotrophomonas maltophilia infection with standard monotherapy either levofloxacin or Trimethoprim/sulfamethoxazole plus placebo
干预措施: Placebo (Drug)
结局指标
主要结局
mortality rate
时间窗: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
mortality rate of S. maltophilia infected patients receiving treatment at day 28
次要结局
- adverse drug reactions(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- microbiological clearance(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)