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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002063-95-IT

Enrollment

238

Registered

2021-05-24

Start date

2020-05-29

Completion date

Unknown

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

latent 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

Interventions

Trade Name: RIFADIN - 300 MG CAPSULE RIGIDE8 CAPSULE Product Name: rifampicina Product Code: [rifampicina] Pharmaceutical Form: Capsule, hard INN or Proposed INN: 00249750 Current Sponsor code: rifamp

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary objectives of this study include: A. To evaluate adherence to treatment in the two groups measured by counting number of pills taken in each group. B. To compare the rates of any grade and grade 3, 4, or 5 liver toxicity associated with 1RPT/H, and 3RH C. To compare the rates of drug discontinuation due to adverse drug reactions associated with 1RPT/H and 3RH. D. To compare the rates of drug discontinuation for any reason associated with 1RPT/H and 3RH.;Primary end point(s): Completion of the prescribed regimen, defined as taking at least 90% of the doses: • 28 doses [at least 25 doses] of each drug within 4 weeks of treatment initiation with daily 1RPT/H (Arm 1); • 84 doses [at least 76 doses] within 12 weeks of treatment initiation with daily 3HR (Arm 2);;Timepoint(s) of evaluation of this end point: 4 weeks 12 weeks;Main Objective: The primary objective of this open-label randomized clinical trial is to compare completion rate, adherence and safety between the study regimen, 4 weeks rifapentine and isoniazid (1RPT/H) and the standard of care, 12 weeks isoniazid plus rifampicin (3HR).	—

Measure

Time frame

Secondary Objective: The secondary objectives of this study include: A. To evaluate adherence to treatment in the two groups measured by counting number of pills taken in each group. B. To compare the rates of any grade and grade 3, 4, or 5 liver toxicity associated with 1RPT/H, and 3RH C. To compare the rates of drug discontinuation due to adverse drug reactions associated with 1RPT/H and 3RH. D. To compare the rates of drug discontinuation for any reason associated with 1RPT/H and 3RH.;Primary end point(s): Completion of the prescribed regimen, defined as taking at least 90% of the doses: • 28 doses [at least 25 doses] of each drug within 4 weeks of treatment initiation with daily 1RPT/H (Arm 1); • 84 doses [at least 76 doses] within 12 weeks of treatment initiation with daily 3HR (Arm 2);;Timepoint(s) of evaluation of this end point: 4 weeks 12 weeks;Main Objective: The primary objective of this open-label randomized clinical trial is to compare completion rate, adherence and safety between the study regimen, 4 weeks rifapentine and isoniazid (1RPT/H) and the standard of care, 12 weeks isoniazid plus rifampicin (3HR).

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Secondary

Measure	Time frame
Secondary end point(s): 1. Mean proportion of cumulative number of pills taken for each group; tollerability;Timepoint(s) of evaluation of this end point: 4 weeks 12 weeks; 8 weeks 16 weeks	—

Countries

Italy

Contacts

Public ContactPROGETTAZIONE RICERCA CLINICA E STU

ASST SPEDALI CIVILI DI BRESCIA

coordinamento.ricerca@asst-spedalicivili.it0303996125

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026