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SUSPENDED
NCT04694586
PHASE2

Drug Exposure and Safety of a Shorter Tuberculosis Treatment Based on High-Dose Rifampicin and Pyrazinamide

Sponsor: University Hospital, Linkoeping

View on ClinicalTrials.gov

Summary

Tuberculosis (TB) treatment is long and complex with the risk of poor treatment adherence and treatment failure. Several attempts to shorten treatment of drug-susceptible TB have been unsuccessful. However, recent data support a shortened regimen for mild and moderate pulmonary TB and simultaneous optimization of rifampicin (RIF) and pyrazinamide (PZA). This phase II clinical study aim to investigate a strategy to shorten TB treatment by exploring safety and drug exposure of a high-dose sterilizing TB regimen.

Official title: A Prospective Multicenter Phase II-study: Pharmacokinetics and Safety of High-Dose Rifampicin and Pyrazinamide in a Shorter Tuberculosis Treatment Compared With Standardized Treatment in Patients With Mild to Moderate Pulmonary TB

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2022-11-30

Completion Date

2030-05-31

Last Updated

2026-08-17

Healthy Volunteers

No

Interventions

DRUG

rifampicin

rifampicin 35 mg/kg

DRUG

pyrazinamide

pyrazinamide 40 mg/kg

DRUG

HRZE

isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg combination tablets

DRUG

HR

isoniazid 75 mg + rifampicin 150 mg combination tablets

Locations (1)

Linköping University Hospital

Linköping, Sweden