Randomized controlled trial on daily Rifampicin for Four Months Compared with daily Rifampicin/Isoniazid for Three Months for the Treatment of Tuberculosis Infection among migrants: Completion Rate and Side Effects - ITL-2021

AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA0 个研究点目标入组 264 人开始时间: 2021年8月2日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•Asylum seekers (AS) and refugees hosted in the SPRAR or CAS centers 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
•=5 years since arrival in Europe
•=18 years old
•Diagnosis of Tuberculosis Infection (TBI)
•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 244
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Current confirmed culture-positive or clinical TB
•Suspected TB
•History of sensitivity/intolerance to any of the study drugs
•<18 years old
•Diagnosis of porphyria
•Pregnant or breast-feeding females
•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)
•HIV positive
•Previous treatment for TB or TBI

发起方