MedTrace Logo

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

NCT04694586 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-05

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Pulmonary

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

Sponsors & Collaborators

  • Linkoeping University

    collaborator OTHER_GOV

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Katarina Niward, MD, PhD · Linkoeping University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2024-05-31
Completion
2026-05-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04694586 on ClinicalTrials.gov