Nine Months' Short Course Regimen Protocol for the Treatment of Multidrug Resistance-tuberculosis (MDR-TB) Patients in Gabon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- cure rate post treatment
研究概览
简要总结
The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.
详细描述
Study participants will be followed up, under existing protocol derived from a study protocol developed by the "Union internationale contre les maladies respiratoires" and carried out already in 9 Africans countries. Participants will be hospitalised for at least four month, period which they will be given treatments, assessed for adverse events, monitored for TB-MR strains using culture techniques, at the monthly basis. If patients found with negative sputum culture at month four they will be dischrged from the hospital, and then treated four an additional five montns and then follow up, clinically and biologically for an additional six months before being declared as cured.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Aged 15 years and above
- •Never been treated with second line anti-TB drugs for more than one month,
- •Give written consent to participate
- •Agree to be hospitalised for at least four months in specialised healthcare
- •Willing to adhere to ambulatory directly observed treatment by a healthcare worker;
排除标准
- •Pregnant during inclusion process
- •Presented with altered clinical status condition as judged by the clinician
- •Knowing of history of hypersensitivity reaction to any of the drugs to be used
- •Baseline ECG does not show a QT space superior to 500ms
- •Refusal to participate into study.
研究组 & 干预措施
TB-MR patients
Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z
干预措施: Km+ Mfx+ Pto + H + Cfz +E+Z (Combination Product)
结局指标
主要结局
cure rate post treatment
时间窗: Six months post treatment
Proportion of participants alive and presented with negative sputum culture for TB and with the absence of clinical, X-Ray and biological disorders related to TB
次要结局
- TB-culture(4 months after start of the treatment)
- Regimen tolorability(Throughout treatment period (9months))
- Adverse events(duration of participant in the study (15months))
研究者
Prof. Ayola Akim ADEGNIKA
Professor
Centre de Recherche Médicale de Lambaréné