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

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ClinicalTrials.gov Identifier: NCT04545788

Recruitment Status : Recruiting

First Posted : September 11, 2020

Last Update Posted : September 16, 2020

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Sponsor:

Information provided by (Responsible Party):

Chu naihu, Beijing Chest Hospital

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.

Condition or disease	Intervention/treatment	Phase
Tuberculosis	Drug: Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized, Controlled, Multi-center Clinical Trial of Short Course Treatment for Newly Diagnosed Rifampicin Resistant Tuberculosis
Actual Study Start Date :	August 1, 2020
Estimated Primary Completion Date :	December 31, 2022
Estimated Study Completion Date :	December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Drug Information available for: Cycloserine Rifampin Linezolid Bedaquiline

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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).	Drug: 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.
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.

Outcome Measures

Primary Outcome Measures :

Culture of Mycobacterium tuberculosis in sputum. [ Time Frame: Through study completion, an average of 1 year. ]
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. [ Time Frame: Through study completion, an average of 1 year. ]
All the types and frequency of adverse reactions that related to anti-tuberculosis drug were collected.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545788

Contacts

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Contact: WENJUAN NIE, Director	+86 13552156672	wenjuan.nie@outlook.com
Contact: JING LIU, Doctor	+86 13810654836	liujingworkbj@126.com

Locations

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China, Beijing
Beijing Chest Hospital affiliated to Capital Medical University	Recruiting
Beijing, Beijing, China, 101149
Contact: NAIHUI CHU, Director +86 10 89509301 dongchu1994@sina.com

Sponsors and Collaborators

Beijing Chest Hospital

Investigators

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Principal Investigator:	NAIHUI CHU, Doctor	Beijing Chest Hospital affiliated to Capital Medical University

More Information

Publications:

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.

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). pii: e02149-17. doi: 10.1128/AAC.02149-17. Print 2018 Apr.

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.

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.

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Responsible Party:	Chu naihu, TB Director, Beijing Chest Hospital
ClinicalTrials.gov Identifier:	NCT04545788
Other Study ID Numbers:	GCP-TB
First Posted:	September 11, 2020 Key Record Dates
Last Update Posted:	September 16, 2020
Last Verified:	September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Chu naihu, Beijing Chest Hospital:


Tuberculosis, rifampin resistant, oral, shorter.

Additional relevant MeSH terms:

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Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Cycloserine Linezolid Bedaquiline	Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors Enzyme Inhibitors

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