Research on New Regimens for Retreatment Pulmonary Tuberculosis

NCT02331823 | Unknown Phase 4 DMC

• 1 other identifier: 2013ZX10003009
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-center, prospective study is performed to investigate the efficacy of new short-course regimen for retreatment pulmonary tuberculosis patients. To obtain optimized short-course regimen, decrease treatment cost and improve success rate.

Conditions

Reinfection Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (1)

• success rate

  for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.

Secondary Outcomes (1)

• adverse reaction rate

  for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.

Study Arms (2)

arm A: super-short retreatment regimen

EXPERIMENTAL

A regimen of 5 drugs is to be administered. Isoniazid Aminosalicylate Tablets,0.3g tid po for 5 mon moxifloxacin tab, 0.4g qd po for 5 mon rifabutin capsule,0.3g qd po for 5 mon ethambutol tab, 0.75g qd po for 5 mon pyrazinamide tab, 0.5g tid po for 5 mon

Drug: Isoniazid Aminosalicylate Tablets

arm B:standardized retreatment regimen

ACTIVE COMPARATOR

8-9 months of standardized regimen is to be administered. regimen 1.2SHREZ/6HRE streptomycin injectable,0.75g qd intramuscular for 2 mon isoniazid tab,0.3g qd po for 8 mon rifampicin capsule,0.45-0.6g po for 8 mon ethambutol tab, 0.75g qd po for 8 mon pyrazinamide tab, 0.5g tid po for 2 mon or regimen 2.3HREZ/6HRE isoniazid tab,0.3g qd po for 9 mon rifampicin capsule,0.45-0.6g po for 9 mon ethambutol tab, 0.75g qd po for 9 mon pyrazinamide tab, 0.5g tid po for 3 mon

Drug: Streptomycin injectable

Interventions

Isoniazid Aminosalicylate Tablets DRUG

a regimen consists of 5 anti-TB drugs (Isoniazid Aminosalicylate Tablets+pyrazinamide tablets+ethambutol tablets+rifabutin capsules+moxifloxacin tablets)to treat retreatment pulmonary tuberculosis patients. The total treatment course is 5 months.

Also known as: ethambutol tablets, pyrazinamide tablets, rifabutin capsules, moxifloxacin tablets

arm A: super-short retreatment regimen

Streptomycin injectable DRUG

standardized regimen 2 months of streptomycin injectable + isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules or 3 months of isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules to treat Arm B patients as a control to arm A.The treatment course is 8-9 months.

Also known as: isoniazid tablets, ethambutol tablets, rifampicin capsules, pyrazinamide tablets

arm B:standardized retreatment regimen

Eligibility Criteria

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

You may qualify if:

• Sputum confirmed diagnosis of retreatment pulmonary tuberculosis
• Must be able to swallow tablets
• Must be able to sign written informed consent form

You may not qualify if:

• Extra-pulmonary tuberculosis
• Diabetes
• Allergy to any of the medications in the regimen or pregnancy
• Liver disease
• Renal disease
• Metabolic disease
• Immune system disease
• Hematological disease
• Nervous system and mental disease
• Endocrine disease
• Malignant disease
• Receiving immunosuppressive therapy
• HIV/AIDS
• Alcohol addiction

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Shanghai Center for Disease Control and Prevention: collaborator
• Jiangsu Province Centers for Disease Control and Prevention: collaborator
• Zhejiang University: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (1)

• Yan L, Kan X, Zhu L, Xu K, Yin J, Jie L, Li Y, Yue J, Cui W, Du J, Wang L, Tan S, Jiang X, Zeng Z, Xu S, Wang L, Chen Y, He W, Gao X, Bai D, Zhao C, Yan X, Zhu Y, Fan Y, Xie L, Deng A, Zhang Q, Xiao H. Short-course Regimen for Subsequent Treatment of Pulmonary Tuberculosis: A Prospective, Randomized, Controlled Multicenter Clinical Trial in China. Clin Ther. 2018 Mar;40(3):440-449. doi: 10.1016/j.clinthera.2018.01.013. Epub 2018 Mar 6.

  PMID: 29519716 DERIVED

MeSH Terms

Interventions

Ethambutol; Pyrazinamide; Rifabutin; Moxifloxacin; Isoniazid; Rifampin

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Hydrazines; Isonicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Heping Xiao, M.D

  Shanghai Pulmonary Hospital,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Zhang, M.D

CONTACT

8621-65115006; zhqi709851@sohu.com

Wei Sha, M.D

CONTACT

8621-65115006; shfksw@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 6, 2015
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

CN (1)