Research on New Regimens for Retreatment Pulmonary Tuberculosis

January 2, 2015 updated by: Qing Zhang, Shanghai Pulmonary Hospital, Shanghai, China

New Super-short Course Regimen for Retreatment Pulmonary Tuberculosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

864

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wei Sha, M.D
  • Phone Number: 2017 8621-65115006
  • Email: shfksw@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Qing Zhang, M.d

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arm A: super-short retreatment regimen
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
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.
Other Names:
  • ethambutol tablets
  • pyrazinamide tablets
  • rifabutin capsules
  • moxifloxacin tablets
Active Comparator: arm B:standardized retreatment regimen
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
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.
Other Names:
  • ethambutol tablets
  • pyrazinamide tablets
  • isoniazid tablets
  • rifampicin capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
success rate
Time Frame: 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.
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

Outcome Measure
Time Frame
adverse reaction rate
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Collaborators

Centers for Disease Control and Prevention
Zhejiang University
Jiangsu Province Centers for Disease Control and Prevention
Shanghai Center for Disease Control and Prevention

Investigators

  • Principal Investigator: Heping Xiao, M.D, Shanghai Pulmonary Hospital,China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 2, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013ZX10003009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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