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Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contizolid and Dlamanid Cohort (INSPIRE-CODA)

Primary Purpose

Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Bedaquiline
Delamanid
Contezolid
Levofloxacin
Moxifloxacin
Clofazimine
Linezolid
Cycloserine
Prothionamide
Pyrazinamide
Para-Aminosalicylic Acid
Ethambutol
Sponsored by
Beijing Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Tuberculosis focused on measuring tuberculosis, Rifampicin-resistant, short regimen, contezolid, dlamanid

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newly diagnosed or recurrent rifampicin-resistant tuberculosis confirmed by phenotypic or molecular drug sensitivity test within 60d before screening Himself/herself (together with his/her guardian for age under 18 years old) willing to participate both study treatment and follow-up, and sign informed consent. Exclusion Criteria: Inadequate liver or renal function, history of serious allergic reaction to one or more study drugs, or with other contraindication to study drugs. Combined extrapulmonary tuberculosis(except for tuberculous pleuritis, endobronchial tuberculosis and tubercular lymphadenitis) Expected survival ≤3m by investigator Women in pregnancy or breast feeding period Used any of the study drugs for more than 2w within 3 months before screening

Sites / Locations

  • Beijing Chest Hospital affiliated to Capital Medical University
  • Hebei Chest Hospital
  • Harbin Chest Hospital
  • Infectious Disease Hospital of Hulunbuir
  • Qingdao Chest Hospital
  • Taiyuan Fourth People's Hospital
  • The 8th Medical Center of Chinese Pla General Hospital
  • Changsha Central Hospital
  • Hunan Province Chest Hospital
  • Chongqing Public Heath Treatment Center
  • Dalian Public Health Center
  • Fuzhou Pulmonary Hospital of Fujian
  • Guangzhou Chest Hospital
  • Heilongjiang Province center for tuberculosis Control and Prevention
  • Second Affiliated Hospital of Hainan Medical University
  • Hangzhou Red Cross Hospital
  • Anhui Chest Hospital
  • Second People's Hospital of Hohhot
  • Jiamusi Infectious Disease Hospital
  • Jiamusi Tumor Hospital
  • Jilin Tuberculosis Hospital
  • People's Hospital of Linyi
  • Second Hospital of Nanjing
  • Fourth People's Hospital of Nanning
  • Guangxi Chest Hospital
  • Shandong public health clinical center
  • National Medical Center for Infectious Disease
  • Affiliated Hospital of Shaoxing University
  • Shenyang Chest Hospital
  • Tianjin Haihe Hospital
  • Second People's Hospital of Weifang
  • Wuhan Institute For Tuberculosis Control
  • Xi'an Chest Hospital
  • First Affiliated Hospital of Xiamen Medical University
  • The First Affiliated Hospital of Xinxiang Medical University
  • Henan Provincial Chest Hospital
  • Affiliated Hospital of Zunyi Medical University
  • The 8th Affiliated Hospital of Xinjiang Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short-Term Regimen

Standard Regimen

Arm Description

Intervention will be determined based on Fluoroquinolones(FQs) resistance. For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months For those resistant to FQs: BDQ DLM CZD CFZ for 6 months

Intervention will be determined based on Fluoroquinolones(FQs) resistance. For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB

Outcomes

Primary Outcome Measures

Favourable outcome rate at 12 months after treatment completion
The proportion of participants with a favourable outcome. A participant's outcome will be classified as favourable if their last two sputum culture results are negative unless they have previously been classified as unfavourable. These two cultures must be taken on separate visits (with ≥7d interval); the latest of which being within the month 15-17 from randomization (month 27-29 in the control arm). Participants that don't have a culture result within the time frame because they were unable to produce sputum, will be classified as favourable if their last two cultures are negative and they have not previously been classified as unfavourable.

Secondary Outcome Measures

Unfavourable outcome rate at 12 months after treatment completion
The proportion of participants with an unfavourable outcome. A participant's outcome will be classified as unfavorable if they: don't have at least one negative sputum culture result at month 15-17 (month 27-29 in control arm) switch treatment because of adverse event / inefectiveness / aquired resistance re-start other anti-TB regimen at anytime during the study prolong treatment over the study regimen discontinue all the assigned drugs for ≥2 months die for any reason during treatment and follow up period
Time to culture conversion
Time from treatment initiation to first negative result in sputum culture confirmed by two consecutive cultures with an interval of ≥7d
Grade 3 or higher adverse event rate
Proportion of participants experiencing at least one grade 3 or higher adverse event, or serious adverse event defined by the Division of AIDS severity criteria for adverse events

Full Information

First Posted
September 27, 2023
Last Updated
October 11, 2023
Sponsor
Beijing Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06081361
Brief Title
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contizolid and Dlamanid Cohort
Acronym
INSPIRE-CODA
Official Title
A Multicenter, Randomized, Open-Label Study To Evaluate The Efficacy And Safety Of A Contezolid And Dlamanid-Containing Short Regimen For The Treatment Of Rifampicin-Resistant Pulmonary Tuberculosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 21, 2023 (Anticipated)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Dlamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main question[s] it aims to answer are: Is the efficacy of short regimen better the standard regimen? Is the short regimen safe enough to replace the standard regimen? Participants will: Be given with either short or standard regimen for RR-TB treatment Be asked to complete the scheduled visit as planned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
Keywords
tuberculosis, Rifampicin-resistant, short regimen, contezolid, dlamanid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short-Term Regimen
Arm Type
Experimental
Arm Description
Intervention will be determined based on Fluoroquinolones(FQs) resistance. For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months For those resistant to FQs: BDQ DLM CZD CFZ for 6 months
Arm Title
Standard Regimen
Arm Type
Active Comparator
Arm Description
Intervention will be determined based on Fluoroquinolones(FQs) resistance. For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
Intervention Type
Drug
Intervention Name(s)
Bedaquiline
Other Intervention Name(s)
BDQ
Intervention Description
Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week
Intervention Type
Drug
Intervention Name(s)
Delamanid
Other Intervention Name(s)
DLM
Intervention Description
Oral, 100mg bid
Intervention Type
Drug
Intervention Name(s)
Contezolid
Other Intervention Name(s)
CZD
Intervention Description
Oral, 800mg bid
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
LFX
Intervention Description
Oral, 400mg qd for weight <50kg, 600-750mg qd for weight ≥50kg
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
MFX
Intervention Description
Oral, 400mg qd
Intervention Type
Drug
Intervention Name(s)
Clofazimine
Other Intervention Name(s)
CFZ
Intervention Description
Oral, 100mg qd
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
LZD
Intervention Description
Oral, 600mg qd
Intervention Type
Drug
Intervention Name(s)
Cycloserine
Other Intervention Name(s)
CS
Intervention Description
Oral, 250mg bid
Intervention Type
Drug
Intervention Name(s)
Prothionamide
Other Intervention Name(s)
Pto
Intervention Description
Oral, 600mg qd for weight <50kg, 600-800mg qd for weight ≥50kg
Intervention Type
Drug
Intervention Name(s)
Pyrazinamide
Other Intervention Name(s)
PZA
Intervention Description
Oral, 1500mg qd for weight <50kg, 1750mg qd for weight ≥50kg
Intervention Type
Drug
Intervention Name(s)
Para-Aminosalicylic Acid
Other Intervention Name(s)
PAS
Intervention Description
8000mg qd for weight <50kg, 10000mg qd for weight ≥50kg
Intervention Type
Drug
Intervention Name(s)
Ethambutol
Other Intervention Name(s)
EMB
Intervention Description
750mg qd for weight <50kg, 1000mg qd for weight ≥50kg
Primary Outcome Measure Information:
Title
Favourable outcome rate at 12 months after treatment completion
Description
The proportion of participants with a favourable outcome. A participant's outcome will be classified as favourable if their last two sputum culture results are negative unless they have previously been classified as unfavourable. These two cultures must be taken on separate visits (with ≥7d interval); the latest of which being within the month 15-17 from randomization (month 27-29 in the control arm). Participants that don't have a culture result within the time frame because they were unable to produce sputum, will be classified as favourable if their last two cultures are negative and they have not previously been classified as unfavourable.
Time Frame
Treatment initiation to 12 months after the completion of assigned treatment
Secondary Outcome Measure Information:
Title
Unfavourable outcome rate at 12 months after treatment completion
Description
The proportion of participants with an unfavourable outcome. A participant's outcome will be classified as unfavorable if they: don't have at least one negative sputum culture result at month 15-17 (month 27-29 in control arm) switch treatment because of adverse event / inefectiveness / aquired resistance re-start other anti-TB regimen at anytime during the study prolong treatment over the study regimen discontinue all the assigned drugs for ≥2 months die for any reason during treatment and follow up period
Time Frame
Treatment initiation to 12 months after the completion of assigned treatment
Title
Time to culture conversion
Description
Time from treatment initiation to first negative result in sputum culture confirmed by two consecutive cultures with an interval of ≥7d
Time Frame
Treatment initiation to 12 months after the completion of assigned treatment
Title
Grade 3 or higher adverse event rate
Description
Proportion of participants experiencing at least one grade 3 or higher adverse event, or serious adverse event defined by the Division of AIDS severity criteria for adverse events
Time Frame
Treatment initiation to 12 months after the completion of assigned treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed or recurrent rifampicin-resistant tuberculosis confirmed by phenotypic or molecular drug sensitivity test within 60d before screening Himself/herself (together with his/her guardian for age under 18 years old) willing to participate both study treatment and follow-up, and sign informed consent. Exclusion Criteria: Inadequate liver or renal function, history of serious allergic reaction to one or more study drugs, or with other contraindication to study drugs. Combined extrapulmonary tuberculosis(except for tuberculous pleuritis, endobronchial tuberculosis and tubercular lymphadenitis) Expected survival ≤3m by investigator Women in pregnancy or breast feeding period Used any of the study drugs for more than 2w within 3 months before screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjuan Nie, M.D.
Phone
010-89509331
Email
94642975@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Naihui Chu, Ph.D.
Phone
010-89509301
Email
dongchu1994@sina.com
Facility Information:
Facility Name
Beijing Chest Hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Hebei Chest Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Harbin Chest Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Infectious Disease Hospital of Hulunbuir
City
Hulunbuir
State/Province
Inner Mongolia
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan Zhang
Facility Name
Qingdao Chest Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Taiyuan Fourth People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
The 8th Medical Center of Chinese Pla General Hospital
City
Beijing
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
Country
China
Facility Name
Hunan Province Chest Hospital
City
Changsha
Country
China
Facility Name
Chongqing Public Heath Treatment Center
City
Chongqing
Country
China
Facility Name
Dalian Public Health Center
City
Dalian
Country
China
Facility Name
Fuzhou Pulmonary Hospital of Fujian
City
Fuzhou
Country
China
Facility Name
Guangzhou Chest Hospital
City
Guangzhou
Country
China
Facility Name
Heilongjiang Province center for tuberculosis Control and Prevention
City
Haerbin
Country
China
Facility Name
Second Affiliated Hospital of Hainan Medical University
City
Haikou
Country
China
Facility Name
Hangzhou Red Cross Hospital
City
Hangzhou
Country
China
Facility Name
Anhui Chest Hospital
City
Hefei
Country
China
Facility Name
Second People's Hospital of Hohhot
City
Hohhot
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangqian Yang
Facility Name
Jiamusi Infectious Disease Hospital
City
Jiamusi
Country
China
Facility Name
Jiamusi Tumor Hospital
City
Jiamusi
Country
China
Facility Name
Jilin Tuberculosis Hospital
City
Jilin
Country
China
Facility Name
People's Hospital of Linyi
City
Linyi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiying Liu
Facility Name
Second Hospital of Nanjing
City
Nanjing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Zhang
First Name & Middle Initial & Last Name & Degree
Xiangrong Zhang
Facility Name
Fourth People's Hospital of Nanning
City
Nanning
Country
China
Facility Name
Guangxi Chest Hospital
City
Nanning
Country
China
Facility Name
Shandong public health clinical center
City
Shandong
Country
China
Facility Name
National Medical Center for Infectious Disease
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhong Zhang, PhD
Phone
52888123
Email
zhangwenhong@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Feng Sun, PhD
Facility Name
Affiliated Hospital of Shaoxing University
City
Shaoxing
Country
China
Facility Name
Shenyang Chest Hospital
City
Shenyang
Country
China
Facility Name
Tianjin Haihe Hospital
City
Tianjin
Country
China
Facility Name
Second People's Hospital of Weifang
City
Weifang
Country
China
Facility Name
Wuhan Institute For Tuberculosis Control
City
Wuhan
Country
China
Facility Name
Xi'an Chest Hospital
City
Xi'an
Country
China
Facility Name
First Affiliated Hospital of Xiamen Medical University
City
Xiamen
Country
China
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
Country
China
Facility Name
Henan Provincial Chest Hospital
City
Zhengzhou
Country
China
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
Country
China
Facility Name
The 8th Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
Country
China

12. IPD Sharing Statement

Learn more about this trial

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contizolid and Dlamanid Cohort

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