Health TrialsbyHealthPanel

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

ConditionTuberculosis, Pulmonary
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-85
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-dose rifampicin

    Drug

    30mg/kg

  • Isoniazid

    Drug

    300mg

  • Pyrazinamide

    Drug

    20-30mg/kg

  • Ethambutol

    Drug

    15-20mg/kg

  • Rifampicin

    Drug

    10mg/kg

Treatment groups

926 Participants
are divided into 2 treatment groups
Group A: Arm 1 (Conventional treatment group)Active comparator 4 interventions
Group B: Arm 2 (High-dose rifampicin group)Experimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Chonnam National University Hospital

Collaborator

National Medical Center, Seoul

Collaborator

Pusan National University Hospital

Collaborator

Pusan National University Yangsan Hospital

Collaborator

Seoul National University Bundang Hospital

Collaborator

SMG-SNU Boramae Medical Center

Collaborator

Severance Hospital

Collaborator

Korean Institute of Tuberculosis

Collaborator

International Tuberculosis Research Center

Collaborator

Korean Center for Disease Control and Prevention

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: