A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 667
- 试验地点
- 1
- 主要终点
- 1-year non relapse rate
研究概览
简要总结
This is a randomised, open-labelled, controlled trial to compare the efficacy and effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of melioidosis. The study population includes 800 patients with culture-confirmed melioidosis whom 12 weeks of oral eradication therapy have been completed with or without intravenous intensive antibiotics. Patients will be randomised to either stop the eradication treatment or continue current oral treatment for 8 more weeks. The study aim to optimise the regimen used to treat melioidosis for better compliance and reducing unnecessary use of antibiotics.
详细描述
Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 15 years
- •Culture-confirmed melioidosis
- •Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis
- •High likelihood of completing at least 6 months follow up
- •Willingness to participate in the study and written, informed consent obtained from the patient
排除标准
- •Pregnancy or breast feeding
- •Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment
- •Relapse melioidosis with at least 2 year symptom free period from last episode
研究组 & 干预措施
Co-trimoxazole 12
Receive treatment with co-trimoxazole for 12 weeks.
干预措施: Co-trimoxazole 12 (Drug)
Co-trimoxazole 20
Receive treatment with co-trimoxazole for 20 weeks.
干预措施: Co-trimoxazole 20 (Drug)
结局指标
主要结局
1-year non relapse rate
时间窗: 1 year
This is defined as clinical features of melioidosis after initial improvement, in association with cultures from any site positive for Burkhoderia pseudomallei. This can be any time point during or after stopping antibiotic treatment.
次要结局
- Clinical Recurrence(1 year)
- Treatment failure(9 weeks)
- Mortality(1 year)
- Adverse Drug Reactions(9 weeks)
- Drug compliance(12 or 20 weeks)
研究者
Siriluck Anunnatsiri
MD
Khon Kaen University