EUCTR2019-002063-95-IT进行中（未招募）1 期
A Phase 3, Open, Randomized controlled trial on Completion Rate of daily Rifapentine/Isoniazid for One Month Compared with Daily Rifampicin/Isoniazid for Three Months for the Treatment of Latent Tuberculosis Infection among asylum seekers and refugees - ITL2019
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA0 个研究点目标入组 238 人开始时间: 2021年5月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 238
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Man and woman
- •18 years old.HIV negative
- •Asylum seekers (AS) and refugees hosted in the SPRARS or CAS in the province of Brescia, Lombardia
- •Migrants residing in the province of Brescia, identified by the Transcultural and Migration Medicine Centre of ASST of Brescia
- •Diagnosis of Latent Tuberculosis Infection (LTBI)
- •Provision of signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Current confirmed culture-positive or clinical TB
- •Suspected TB
- •History of sensitivity/intolerance to any of the study drugs
- •Pregnant or breast-feeding females
- •Person with diagnosis of Porphyria
- •Patients requiring medications that cannot be safely taken with any of the study drugs
- •Any medical condition deserving priority of treatment
- •Serum aminotransferase aspartate (AST, SGOT) > 5x upper limit of normal at the baseline evaluation
- •Clinical diagnosis of cirrhosis (jaundice, hematemesis, ascites or previous episodes of liver encephalopathy)
- •Previous treatment for TB or LTBI
研究者
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