Tuberculosis Infection MedDRA version: 20.0 Level: PT Classification code 10065048 Term: Latent tuberculosis System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10065048 Term: Latent tuberculosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: RIFINAH - 300 MG + 150 MG COMPRESSE RIVESTITE 24 COMPRESSE
Product Name: RIFAMPICINA/ISONIAZIDE
Product Code: [RIFAMPICINA/ISONIAZIDE]
Pharmaceutical Form: Gastro-resistant tablet
INN or P
Sponsors
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Current confirmed culture-positive or clinical TB Suspected TB History of sensitivity/intolerance to any of the study drugs 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate differences between the two study regimen (4R; 3HR) in terms of completion rate, adherence and side effects among migrant population.;Secondary Objective: A. To compare drug toxicity rates (any grade and grade 3, 4, or 5) associated with 4R and 3RH. B. To compare the rates of drug discontinuation due to adverse drug reactions associated with 4R and 3RH. C. To compare the rates of drug discontinuation for any reason associated with 4R and 3RH.;Primary end point(s): Completion of the prescribed regimen, defined as taking at least 90% of the expected doses: 120 doses [at least 108 doses] of each drug within 120 days of treatment initiation with daily 4R (Arm 1); 90 doses [at least 81 doses] of each drug within 90 days of treatment initiation with daily 3HR (Arm 2);;Timepoint(s) of evaluation of this end point: 90 120 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean proportion of cumulative number of pills taken for each group.; Permanent discontinuation of study drugs due to any adverse drug reactions. Development of any grade and grade 3 or 4 drug-related toxicity. Death due to any cause (grade 5 toxicity). Discontinuation of therapy for any reason.;Timepoint(s) of evaluation of this end point: 90-120 days; 90-120 days | — |
Countries
Italy
Contacts
Public Contactprogettazione ricerca e studi di fa
ASST Spedali Civili di Brescia
Outcome results
None listed