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

Tuberculosis Clinical Trial

Official title:

A Randomized, Controlled, Multi-center Clinical Trial of Short Course Treatment for Newly Diagnosed Rifampicin Resistant Tuberculosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04545788
• Other study ID #: GCP-TB
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2020
• Source: Beijing Chest Hospital
• Contact: WENJUAN NIE, Director
• Phone: +86 13552156672
• Email: wenjuan.nie[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Chest Hospital affiliated to Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 1 year.
Secondary	Adverse effect.	All the types and frequency of adverse reactions that related to anti-tuberculosis drug were collected.	Through study completion, an average of 1 year.