High dose rifampicin for tuberculosis, PORT

Phase 1

• Conditions: Tuberculosis; MedDRA version: 20.0Level: PTClassification code 10037440Term: Pulmonary tuberculosisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 25.1Level: LLTClassification code 10087871Term: Drug-sensitive pulmonary tuberculosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2022-000632-27-DK
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-09
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 164

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified