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

NCT ID: NCT04545788

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-12-31

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.

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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).

Group Type: ACTIVE_COMPARATOR

Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.

Intervention Type: DRUG

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.

B

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.

Group Type: EXPERIMENTAL

Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.

Intervention Type: DRUG

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.

C

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.

Group Type: EXPERIMENTAL

Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.

Intervention Type: DRUG

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.

Interventions

Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chu naihu

TB Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NAIHUI CHU, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Chest Hospital affiliated to Capital Medical University

Locations

Beijing Chest Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

WENJUAN NIE, Director

Role: CONTACT

wenjuan.nie@outlook.com

+86 13552156672

JING LIU, Doctor

Role: CONTACT

liujingworkbj@126.com

+86 13810654836

Facility Contacts

NAIHUI CHU, Director

Role: primary

dongchu1994@sina.com

+86 10 89509301

References

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.

Reference Type: BACKGROUND

PMID: 31549147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29378718 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31040707 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30876684 (View on PubMed)

Other Identifiers

GCP-TB

Identifier Type: -

Identifier Source: org_study_id