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

Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patients - PORT: Pragmatic Optimized Rifampicin trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53704

Enrollment

Registered

2022-04-11

Start date

2024-01-15

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

tuberculosis

Interventions

We will compare a regimen with an optimized dose of rifampicin, to the standard regimen, as described below: • Experimental arm with daily 1800 mg rifampicin for 6 months: 2HR1800ZE/4HR1800 • Control

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The patient has a diagnosis of pulmonary tuberculosis according to the local diagnostic criteria. The patient is aged 18 years or older at the day of informed consent. No known allergic reactions or toxicity to rifampicin in the past.

Exclusion criteria

Exclusion criteria: Patient infected with a rifampicin-resistant strain of M. tuberculosis. The patient has TB meningitis. The patient is in a coma.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence of hepatotoxicity, which will be compared between treatment arms at the end of the 6 months treatment.	—

Secondary

Measure	Time frame
Secondary endpoints are: • The proportion of adverse events overall and graded by severity assessed to be related or probably related to rifampicin during the 6 months treatment will be compared between treatment arms. • Final treatment outcome at the end of treatment according to WHO definitions of cure will be compared between treatment arms. • Two and three months culture conversion rates will be compared between treatment arms. • Steady-state plasma pharmacokinetic parameters will be compared between treatment arms.	—

Measure

Time frame

Secondary endpoints are: • The proportion of adverse events overall and graded by severity assessed to be related or probably related to rifampicin during the 6 months treatment will be compared between treatment arms. • Final treatment outcome at the end of treatment according to WHO definitions of cure will be compared between treatment arms. • Two and three months culture conversion rates will be compared between treatment arms. • Steady-state plasma pharmacokinetic parameters will be compared between treatment arms.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)