Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509885-39-00

Acronym

PORT

Enrollment

130

Registered

2024-01-11

Start date

2024-01-15

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

Tuberculosis

Brief summary

The incidence of hepatotoxicity

Detailed description

The proportion of adverse events overall and graded by severity assessed to be related or probably related to rifampicin., Final treatment outcome at the end of treatment according to WHO definitions of cure., Two and three months culture conversion rates, Steady-state plasma pharmacokinetic parameters

Interventions

DRUGRIFAMPICIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The incidence of hepatotoxicity	—

Secondary

Measure	Time frame
The proportion of adverse events overall and graded by severity assessed to be related or probably related to rifampicin., Final treatment outcome at the end of treatment according to WHO definitions of cure., Two and three months culture conversion rates, Steady-state plasma pharmacokinetic parameters	—

Countries

Denmark, Italy, Netherlands

Outcome results

None listed

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