Research on New Regimens for Retreatment Pulmonary Tuberculosis

Phase 4

• Conditions: Reinfection Pulmonary Tuberculosis
• Interventions: Drug: Isoniazid Aminosalicylate Tablets; Drug: Streptomycin injectable

• Registration Number: NCT02331823
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Detailed 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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-12-31
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-02
• Last Update Submitted: 2015-01-02
• Study First Posted: 2015-01-06
• Last Update Posted: 2015-01-06
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 864

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm A: super-short retreatment regimen	Isoniazid Aminosalicylate Tablets	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
arm B:standardized retreatment regimen	Streptomycin injectable	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China