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

NCT04545788 | Unknown

• 1 other identifier: GCP-TB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Tuberculosis, rifampin resistant, oral, shorter.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse effect.

  Through study completion, an average of 1 year.

Study Arms (3)

A

ACTIVE COMPARATOR

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.

B

EXPERIMENTAL

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.

C

EXPERIMENTAL

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.

Interventions

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

A; B; C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chest Hospital: lead

Study Sites (1)

Beijing Chest Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 101149, China

RECRUITING

Related 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.

  PMID: 31549147 BACKGROUND

• 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.

  PMID: 29378718 BACKGROUND

• 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.

  PMID: 31040707 BACKGROUND

• 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.

  PMID: 30876684 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• NAIHUI CHU, Doctor

  Beijing Chest Hospital affiliated to Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WENJUAN NIE, Director

CONTACT

+86 13552156672; wenjuan.nie@outlook.com

JING LIU, Doctor

CONTACT

+86 13810654836; liujingworkbj@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: TB Director

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 11, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)