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Research on New Regimens for Retreatment Pulmonary Tuberculosis

NCT02331823 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 864

Last updated 2015-01-06

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Shanghai Center for Disease Control and Prevention

    collaborator OTHER

  • Jiangsu Province Centers for Disease Control and Prevention

    collaborator NETWORK

  • Zhejiang University

    collaborator OTHER

  • Centers for Disease Control and Prevention

    collaborator FED

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Principal Investigators

  • Heping Xiao, M.D · Shanghai Pulmonary Hospital,China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02331823 on ClinicalTrials.gov