Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04485156

Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)

The purpose of this study is to investigate the effectiveness and safety of the regimen including high dose rifampicin for individualized duration (3 months after Culture Conversion) for the treatment of drug-sensitive pulmonary tuberculosis.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented positivity by sputum Xpert MTB/RIF assay
  • Administration of current tuberculosis therapy (if any) for no more than 7 days (≤7) at the time of enrolment.

Exclusion criteria

  • Negative on Xpert MTB/RIF assay
  • Resistance to rifampicin as detected by an Xpert MTB/RIF assay
  • Known resistance to isoniazid, rifampicin, or pyrazinamide
  • HIV positive
  • Cancer patient on anti-cancer chemotherapy
  • Uncontrolled DM
  • Chronic hepatitis, liver cirrhosis
  • Any contraindications of drugs to be used

Treatment and study plan

High-dose rifampicin

Drug

30mg/kg

Isoniazid

Drug

300mg

Pyrazinamide

Drug

20-30mg/kg

Ethambutol

Drug

15-20mg/kg

rifampicin

Drug

10mg/kg

Primary outcomes

  1. Incidence of unfavorable treatment outcomes between two arms

    Time frame: Within 18 months of randomization

Secondary outcomes

  1. Time to unfavorable treatment outcomes

    Time frame: Within 18 months of randomization

  2. Time to culture conversion on liquid media

    Time frame: Censored at 2 months of treatment

  3. Proportion of participants with treatment success

    Time frame: At the end of treatment

  4. Proportion of participants with relapse of same strain

    Time frame: At the end of study

  5. Time to relapse with same strain

    Time frame: through study completion, 18months after randomization

  6. Occurrence of AEs grade 3 and above

    Time frame: through study completion, 18months after randomization

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Chonnam National University Hospital
  • International Tuberculosis Research Center
  • Korean Center for Disease Control and Prevention
  • Korean Institute of Tuberculosis
  • National Medical Center, Seoul
  • Pusan National University Hospital
  • Pusan National University Yangsan Hospital
  • SMG-SNU Boramae Medical Center
  • Seoul National University Bundang Hospital
  • Severance Hospital

Registry information

Official study title

Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin to 3 Months After Culture Conversion (Hi-DoRi-3): A Phase 3, Multicenter, Randomized, Open-label, Clinical Trial

Acronym: Hi-DoRi-3

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jul 24, 2020
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.