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

Phase 1

Active, not recruiting

• Conditions: latent tuberculosis infection; MedDRA version: 20.0Level: PTClassification code 10065048Term: Latent tuberculosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-002063-95-IT
• Lead Sponsor: AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-24
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified