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

Primary Purpose

Tuberculosis, Pulmonary

Status

Not yet recruiting

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

High-dose rifampicin

Isoniazid

Pyrazinamide

Ethambutol

Rifampicin

About this trial

This is an interventional treatment trial for Tuberculosis, Pulmonary focused on measuring Tuberculosis, Rifampicin, Treatment, Shortening

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1 (Conventional treatment group)

Arm 2 (High-dose rifampicin group)

Arm Description

Will be treated as recommended by Korean Guidelines For Tuberculosis as well as WHO guidelines (e.g. isoniazid, rifampicin, ethambutol, and pyrazinamide for 2 months followed by isoniazid, rifampicin, (and ethambutol)) Duration of the treatment - 6 months in total

High-dose rifampicin, isoniazid, and pyrazinamide Rifampicin: 30mg/kg Isoniazid: 300mg/day Pyrazinamide: 1000mg/day (<50kg), 1500mg/day (50-70kg), 2000mg /day (>70kg), till culture conversion Duration of the treatment Till 12 weeks after culture conversion on liquid media

Outcomes

Primary Outcome Measures

Incidence of unfavorable treatment outcomes between two arms

Secondary Outcome Measures

Time to unfavorable treatment outcomes

Time to culture conversion on liquid media

Proportion of participants with treatment success

Proportion of participants with relapse of same strain

Time to relapse with same strain

Occurrence of AEs grade 3 and above

Full Information

NCT ID

NCT04485156

First Posted

July 6, 2020

Last Updated

July 21, 2020

Sponsor

Seoul National University Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04485156

Brief Title

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

Acronym

Hi-DoRi-3

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2020 (Anticipated)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis, Pulmonary

Keywords

Tuberculosis, Rifampicin, Treatment, Shortening

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

926 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 (Conventional treatment group)

Arm Type

Active Comparator

Arm Description

Arm Title

Arm 2 (High-dose rifampicin group)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

High-dose rifampicin

Intervention Description

30mg/kg

Intervention Type

Drug

Intervention Name(s)

Isoniazid

Intervention Description

300mg

Intervention Type

Drug

Intervention Name(s)

Pyrazinamide

Intervention Description

20-30mg/kg

Intervention Type

Drug

Intervention Name(s)

Ethambutol

Intervention Description

15-20mg/kg

Intervention Type

Drug

Intervention Name(s)

Rifampicin

Intervention Description

10mg/kg

Primary Outcome Measure Information:

Title

Incidence of unfavorable treatment outcomes between two arms

Time Frame

Within 18 months of randomization

Secondary Outcome Measure Information:

Title

Time to unfavorable treatment outcomes

Time Frame

Within 18 months of randomization

Title

Time to culture conversion on liquid media

Time Frame

Censored at 2 months of treatment

Title

Proportion of participants with treatment success

Time Frame

At the end of treatment

Title

Proportion of participants with relapse of same strain

Time Frame

At the end of study

Title

Time to relapse with same strain

Time Frame

through study completion, 18months after randomization

Title

Occurrence of AEs grade 3 and above

Time Frame

through study completion, 18months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35978342

Citation

Kwak N, Jeon D, Park Y, Kang YA, Kim KJ, Kim YR, Kwon BS, Kwon YS, Kim HJ, Lee JH, Lee JY, Lee JK, Mok J, Cheon M, Park J, Hahn S, Yim JJ. Treatment shortening of drug-sensitive pulmonary tuberculosis using high-dose rifampicin for 3 months after culture conversion (Hi-DoRi-3): a study protocol for an open-label randomized clinical trial. Trials. 2022 Aug 17;23(1):666. doi: 10.1186/s13063-022-06631-z.

Results Reference

derived

Learn more about this trial

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

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