search
Back to results

Randomized Controlled Multi-center Short Course Treatment for Rifampicin Resistant Tuberculosis

Primary Purpose

Tuberculosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.
Sponsored by
Beijing Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculosis focused on measuring Tuberculosis, rifampin resistant, oral, shorter.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • signed informed consent and accepted follow-up;
  • the age is between 18 and 65 years old, both male and female, including inpatients and outpatients;
  • no use of anti tuberculosis drugs, or use of anti tuberculosis drugs less than 1 month;
  • the results of molecular biology test confirmed rifampicin resistance or MDR-TB patients;
  • chest CT examination confirmed pulmonary tuberculosis, pulmonary lesions, or cavity;
  • premenopausal women had negative pregnancy urine test and agreed to use high-efficiency contraceptive measures during the study period.

Exclusion Criteria:

  • drug sensitivity test or molecular drug sensitivity results show that the drug resistance (except isoniazid) or any component of the drug has a history of allergy, or is taking any drug that is contraindicated to the drug in the short-term treatment program;
  • severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 ml / min).
  • liver function impairment (ALT and / or AST level 3 times higher than the upper limit of laboratory reference value, if it is temporary increase, it can be included after treatment recovery);
  • those who are unable to participate in or comply with the treatment and follow-up;
  • Q-T interval > 450 millisecond;
  • have a history of cardiovascular diseases or are suffering from such diseases as heart failure, hypertension (poor blood pressure control), arrhythmia or post myocardial infarction state;
  • pregnant or lactating women;
  • those who are unable to take oral drugs;
  • those who are currently participating in other clinical trials;
  • patients with HIV positive or active viral hepatitis.

Sites / Locations

  • Beijing Chest Hospital affiliated to Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

A

B

C

Arm Description

4-6 INH EMB PZA Pto AM Cfz Mfx / 5 EMB PZA Cfz Mfx (INH: Isoniazid, EMB: Ethambutol, PZA: Pyrazinamide, Pto: Prothionamide, AM: Amikacin, Cfz: Clofazimine, Mfx: Moxifloxacin) A group is the control group which includes injectable drugs (AM).

4-6 INH EMB PZA Pto LZD Cfz Mfx / 5 EMB PZA Cfz Mfx (INH: Isoniazid, EMB: Ethambutol, PZA: Pyrazinamide, Pto: Prothionamide, LZD: Linezolid, Cfz: Clofazimine, Mfx: Moxifloxacin) B group is the experimental groups which is total oral short-term therapy.

4-6 BDQ LZD MFX CS CFZ / 5MFX CS CFZ (BDQ: Bedaquiline, LZD: Linezolid, Mfx: Moxifloxacin, CS: Cycloserine, Cfz: Clofazimine) C group is another experimental groups which is also total oral short-term therapy, and includes new anti-TB drugs: BDQ.

Outcomes

Primary Outcome Measures

Culture of Mycobacterium tuberculosis in sputum.
Mycobacterium tuberculosis culture of sputum will be carried out every month to understand the negative conversion rate and time of sputum bacteria, and then to understand the cure rate of patients. The final aim is to understand the efficacy of the total oral short-term anti-tuberculosis regimen.

Secondary Outcome Measures

Adverse effect.
All the types and frequency of adverse reactions that related to anti-tuberculosis drug were collected.

Full Information

First Posted
August 31, 2020
Last Updated
September 11, 2020
Sponsor
Beijing Chest Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04545788
Brief Title
Randomized Controlled Multi-center Short Course Treatment for Rifampicin Resistant Tuberculosis
Official Title
A Randomized, Controlled, Multi-center Clinical Trial of Short Course Treatment for Newly Diagnosed Rifampicin Resistant Tuberculosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (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

5. Study Description

Brief Summary
This study is a randomized, controlled, multi-center clinical study. The main purpose of this study was to study the efficacy and safety data of total oral short-term therapy as an alternative to injection in the treatment of newly diagnosed RR-TB patients.
Detailed Description
A group: 4-6 INH EMB PZA Pto AM Cfz Mfx / 5 EMB PZA Cfz Mfx B group: 4-6 INH EMB PZA Pto LZD Cfz Mfx / 5 EMB PZA Cfz Mfx C group: 4-6 BDQ LZD MFX CS CFZ / 5MFX CS CFZ (INH: Isoniazid, EMB: Ethambutol, PZA: Pyrazinamide, Pto: Prothionamide, AM: Amikacin, Cfz: Clofazimine, Mfx: Moxifloxacin, LZD: Linezolid, BDQ: Bedaquiline, CS: Cycloserine) A group is the control group which includes injectable drugs (AM). B group and C group are the experimental groups which are total oral short-term therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Tuberculosis, rifampin resistant, oral, shorter.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
4-6 INH EMB PZA Pto AM Cfz Mfx / 5 EMB PZA Cfz Mfx (INH: Isoniazid, EMB: Ethambutol, PZA: Pyrazinamide, Pto: Prothionamide, AM: Amikacin, Cfz: Clofazimine, Mfx: Moxifloxacin) A group is the control group which includes injectable drugs (AM).
Arm Title
B
Arm Type
Experimental
Arm Description
4-6 INH EMB PZA Pto LZD Cfz Mfx / 5 EMB PZA Cfz Mfx (INH: Isoniazid, EMB: Ethambutol, PZA: Pyrazinamide, Pto: Prothionamide, LZD: Linezolid, Cfz: Clofazimine, Mfx: Moxifloxacin) B group is the experimental groups which is total oral short-term therapy.
Arm Title
C
Arm Type
Experimental
Arm Description
4-6 BDQ LZD MFX CS CFZ / 5MFX CS CFZ (BDQ: Bedaquiline, LZD: Linezolid, Mfx: Moxifloxacin, CS: Cycloserine, Cfz: Clofazimine) C group is another experimental groups which is also total oral short-term therapy, and includes new anti-TB drugs: BDQ.
Intervention Type
Drug
Intervention Name(s)
Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.
Intervention Description
AM is the traditional anti-TB drugs. Linezolid, bedaquiline and/or cycloserine, that might have potential efficacy of replacing injectable anti-TB drugs, are included into the total oral short-term therapy, and replace AM.
Primary Outcome Measure Information:
Title
Culture of Mycobacterium tuberculosis in sputum.
Description
Mycobacterium tuberculosis culture of sputum will be carried out every month to understand the negative conversion rate and time of sputum bacteria, and then to understand the cure rate of patients. The final aim is to understand the efficacy of the total oral short-term anti-tuberculosis regimen.
Time Frame
Through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
Adverse effect.
Description
All the types and frequency of adverse reactions that related to anti-tuberculosis drug were collected.
Time Frame
Through study completion, an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: signed informed consent and accepted follow-up; the age is between 18 and 65 years old, both male and female, including inpatients and outpatients; no use of anti tuberculosis drugs, or use of anti tuberculosis drugs less than 1 month; the results of molecular biology test confirmed rifampicin resistance or MDR-TB patients; chest CT examination confirmed pulmonary tuberculosis, pulmonary lesions, or cavity; premenopausal women had negative pregnancy urine test and agreed to use high-efficiency contraceptive measures during the study period. Exclusion Criteria: drug sensitivity test or molecular drug sensitivity results show that the drug resistance (except isoniazid) or any component of the drug has a history of allergy, or is taking any drug that is contraindicated to the drug in the short-term treatment program; severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 ml / min). liver function impairment (ALT and / or AST level 3 times higher than the upper limit of laboratory reference value, if it is temporary increase, it can be included after treatment recovery); those who are unable to participate in or comply with the treatment and follow-up; Q-T interval > 450 millisecond; have a history of cardiovascular diseases or are suffering from such diseases as heart failure, hypertension (poor blood pressure control), arrhythmia or post myocardial infarction state; pregnant or lactating women; those who are unable to take oral drugs; those who are currently participating in other clinical trials; patients with HIV positive or active viral hepatitis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WENJUAN NIE, Director
Phone
+86 13552156672
Email
wenjuan.nie@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
JING LIU, Doctor
Phone
+86 13810654836
Email
liujingworkbj@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NAIHUI CHU, Doctor
Organizational Affiliation
Beijing Chest Hospital affiliated to Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chest Hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NAIHUI CHU, Director
Phone
+86 10 89509301
Email
dongchu1994@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31549147
Citation
Du Y, Qiu C, Chen X, Wang J, Jing W, Pan H, Chen W, Liu Y, Li C, Xi X, Yin H, Zeng J, Zhang X, Xu T, Wang Q, Guo R, Wang J, Pang Y, Chu N. Treatment Outcome of a Shorter Regimen Containing Clofazimine for Multidrug-resistant Tuberculosis: A Randomized Control Trial in China. Clin Infect Dis. 2020 Aug 14;71(4):1047-1054. doi: 10.1093/cid/ciz915.
Results Reference
background
PubMed Identifier
29378718
Citation
Wang Q, Pang Y, Jing W, Liu Y, Wang N, Yin H, Zhang Q, Ye Z, Zhu M, Li F, Liu P, Wu T, Chen W, Wu W, Qin Z, Qiu C, Deng Q, Xu T, Wang J, Guo R, Du Y, Wang J, Huang H, Chen X, Chu N. Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02149-17. doi: 10.1128/AAC.02149-17. Print 2018 Apr.
Results Reference
background
PubMed Identifier
31040707
Citation
Wang J, Pang Y, Jing W, Chen W, Guo R, Han X, Wu L, Yang G, Yang K, Chen C, Jiang L, Cai C, Dou Z, Diao L, Pan H, Wang J, Du F, Xu T, Wang L, Li R, Chu N. Efficacy and safety of cycloserine-containing regimens in the treatment of multidrug-resistant tuberculosis: a nationwide retrospective cohort study in China. Infect Drug Resist. 2019 Apr 3;12:763-770. doi: 10.2147/IDR.S194484. eCollection 2019.
Results Reference
background
PubMed Identifier
30876684
Citation
Pang Y, Jing W, Lu J, Zong Z, Huo F, Dong L, Dai G, Li Y, Huang H, Chu N. No in vitro synergistic effect of bedaquiline combined with fluoroquinolones, linezolid, and clofazimine against extensively drug-resistant tuberculosis. Diagn Microbiol Infect Dis. 2019 Aug;94(4):361-364. doi: 10.1016/j.diagmicrobio.2019.02.012. Epub 2019 Feb 19.
Results Reference
background

Learn more about this trial

Randomized Controlled Multi-center Short Course Treatment for Rifampicin Resistant Tuberculosis

We'll reach out to this number within 24 hrs