Research on New Regimens for Retreatment Pulmonary Tuberculosis

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Unknown; Phase 4

Conditions: Reinfection Pulmonary Tuberculosis

Treatments: Drug: Isoniazid Aminosalicylate Tablets; Drug: Streptomycin injectable

Study type: Interventional

Funder types: Other; NETWORK; Other U.S. Federal agency

Identifiers

NCT02331823

2013ZX10003009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 864 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

864 participants in 2 patient groups

arm A: super-short retreatment regimen

Experimental group

Description:

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

Treatment:

Drug: Isoniazid Aminosalicylate Tablets

arm B:standardized retreatment regimen

Active Comparator group

Description:

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

Treatment:

Drug: Streptomycin injectable