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Safety of Rifampicin at High Dose for the Treatment of Adult Subjects with Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519983-42-00
Acronym
RIAlta
Enrollment
50
Registered
2025-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-04

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

Conditions

TUBERCULOSIS

Brief summary

proportion of participants with one or more SAE (i.e. grade 3 or 4 AE) at 8 weeks of treatment

Detailed description

Eficaccy: The proportion of participants with a favorable outcome at 8 weeks of treatment, Tolerability: proportion of participants having one or more AE in the prospective cohort., efficacy: time to sputum culture conversion from positive to negative, Correlation of the AUC/MIC values with time to sputum culture conversion adjusted with other explanatory covariates, changes in quality of life questionnaires and in TB associated costs from all sites will be depicted

Interventions

Sponsors

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
proportion of participants with one or more SAE (i.e. grade 3 or 4 AE) at 8 weeks of treatment

Secondary

MeasureTime frame
Eficaccy: The proportion of participants with a favorable outcome at 8 weeks of treatment, Tolerability: proportion of participants having one or more AE in the prospective cohort., efficacy: time to sputum culture conversion from positive to negative, Correlation of the AUC/MIC values with time to sputum culture conversion adjusted with other explanatory covariates, changes in quality of life questionnaires and in TB associated costs from all sites will be depicted

Countries

Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026