Long Term Post-treatment Follow-up After End of Study (>15 Months) of Clinical Trial Participants Enrolled in DNDi-FOSR-04-MYC
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- To assess recurrence of eumycetoma lesions up to 5 years after end of treatment in participants previously treated with fosravuconazole 200 mg or 300 mg weekly or itraconazole 400 mg daily in study DNDi-FOSR-04-MYC
研究概览
简要总结
To assess the long-term recurrence rate of eumycetoma in clinical trial participants treated in the phase II DNDi-FOSR-04-MYC clinical trial.
详细描述
The purpose of the long-term post treatment follow-up study is to collect data on recurrence of eumycetoma lesions in participants who previously participated in: A randomized, double blind phase II proof-of-concept superiority trial of fosravuconazole 200 mg or 300 mg weekly dose versus itraconazole 400 mg daily, all three arms in combination with surgery, in participants with eumycetoma in Sudan (DNDi-FOSR-04-MYC).
These data will provide additional information on recurrences after end of study (>15 months) of the parent clinical trial (DNDi-FOSR-04-MYC). The study is observational, since there is no intervention in this protocol, but assesses the outcome of the intervention of the parent trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Clinical trial participants who were previously enrolled and received investigational product (fosravuconazole) or standard of care treatment (itraconazole) in the DNDi-FOSR-04-MYC clinical trial.
- •In trial DNDi-FOSR-04-MYC had no recurrence of eumycetoma lesion before month
- •Able and willing to give written informed consent for participation in this study, prior to performance of any study procedures.
排除标准
- •Any condition that, in the opinion of the Principal Investigator or designee, would preclude provision of informed consent or interfere with achieving the study objectives.
结局指标
主要结局
To assess recurrence of eumycetoma lesions up to 5 years after end of treatment in participants previously treated with fosravuconazole 200 mg or 300 mg weekly or itraconazole 400 mg daily in study DNDi-FOSR-04-MYC
时间窗: 6 years
Population: Participants in trial DNDi-FOSR-04-MYC who had no recurrence of eumycetoma lesion before month 15 * Treatment: fosravuconazole 200 mg or 300 mg weekly or itraconazole 400 mg daily in study DNDi-FOSR-04-MYC * Variable: Time to recurrence of eumycetoma lesion (if lesion occurred) or time followed-up without lesion
次要结局
- To determine efficacy of fosravuconazole 200 mg or 300 mg monotherapy vs. itraconazole monotherapy, after long term post-treatment follow-up(15 months)
- To assess overall recurrence of eumycetoma lesions up to 5 years in participants treated with fosravuconazole 200 mg or 300 mg weekly or itraconazole 400 mg daily in study DNDi-FOSR-04-MYC(6 years)
- To describe the etiologic pathogen (subtype of fungus) after long term recurrence(15 months)