Research on New Regimens for Retreatment Pulmonary Tuberculosis

Reinfection Pulmonary Tuberculosis Clinical Trial

Official title:

New Super-short Course Regimen for Retreatment Pulmonary Tuberculosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331823
• Other study ID #: 2013ZX10003009
• Status: Recruiting
• Phase: Phase 4
• First received: December 31, 2014
• Last updated: January 2, 2015
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2015
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Qing Zhang, M.D
• Phone: 8621-65115006
• Email: zhqi709851[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

China is the country with the second highest Tuberculosis (TB) burden in the world. Most of the retreatment TB patients may develop multi-drug resistant. The resistant rate of any of the anti-TB drug is 35.9%, and the multi-drug resistant rate is 15.4%. Retreatment TB becomes one of the factors which inhibit the decrease of morbidity and mortality of TB. It is also a tuff work in TB control. At present the standardized regimen for retreatment TB is 2SHREZ/6HRE or 3HREZ/6HRE. The drugs in the regimen are all first-line anti-TB drugs which are unsuitable for the high drug resistance prevalence, because the cure rate of this regimen is low and the adverse reaction is severe.

Our study is a national multi-center, prospective trail to investigate the efficacy of a new super-short regimen for retreatment TB patients. The new regimen consists of 5 drugs lasting 5 months. The cure rate and success rate of the new regimen is compared with standardized regimen usually 8-9 months in order to obtain the optimized regimen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 864
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Sputum confirmed diagnosis of retreatment pulmonary tuberculosis

• Must be able to swallow tablets

• Must be able to sign written informed consent form

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Reinfection Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• Isoniazid Aminosalicylate Tablets
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.
• Streptomycin injectable
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.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China	Centers for Disease Control and Prevention, Jiangsu Province Centers for Disease Control and Prevention, Shanghai Center for Disease Control and Prevention, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes