Tuberculosis
Conditions
Interventions
Trade Name: Rifampicin
Product Name: Rifampicin
Pharmaceutical Form: Tablet
INN or Proposed INN: RIFAMPICIN
CAS Number: 13292-46-1
Trade Name: Rifampicin
Product Name: Rifampicin
Pharmaceutical Form:
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
All
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. 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 156 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
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 |
|---|---|
| Main Objective: The primary objective is to describe and compare the incidence of hepatotoxicity in standard care and in a regimen with an optimized dose of 1800 mg rifampicin in patients with rifampicin-susceptible tuberculosis. ;Secondary Objective: The secondary objectives are: •To compare any adverse events in the optimized dose regimen versus the standard dose regimen. •To compare final treatment outcome at the end of treatment according to WHO definitions of cure in the optimized dose regimen versus the standard dose regimen. •To compare two and three months culture conversion rates in the optimized dose regimen versus the standard dose regimen. •To describe and compare the steady-state plasma pharmacokinetics of the optimized dose regimen versus the standard dose regimen. This will be performed depending on the availability of pharmacological analyses. ;Primary end point(s): The primary endpoint is the incidence of hepatotoxicity, which will be compared between treatment arms at the end of the 6 months treatment. ;Timepoint(s) of evaluation of this end point: At the end of the 6 months treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: - 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 (6 months) 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. This outcome is evaluated at two and three months. - Steady-state plasma pharmacokinetic parameters will be compared between treatment arms, at day 14. | — |
Countries
Austria, Denmark, Italy, Netherlands
Contacts
Public ContactJodie Schildkraut
Radboud University Medical Center
Outcome results
None listed