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

Phase 1

• Conditions: Tuberculosis Infection; MedDRA version: 20.0Level: PTClassification code 10065048Term: Latent tuberculosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-001438-20-IT
• Lead Sponsor: AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-02
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 264

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br>B. To compare the rates of drug discontinuation due to adverse drug reactions associated with 4R and 3RH.<br>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:<br>120 doses [at least 108 doses] of each drug within 120 days of treatment initiation with daily 4R (Arm 1);<br>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 Outcome Measures

Name	Time	Method
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.<br>Development of any grade and grade 3 or 4 drug-related toxicity.<br>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