Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis

Summary

The purpose of the study is to evaluate the safety and efficacy of two shortened regimens for newly diagnosed smear positive drug susceptible pulmonary tuberculosis in comparison to World Health Organization recommended standard 6-month regimen.

Conditions

• Tuberculosis, Pulmonary

Interventions

DRUG

Isoniazid

Isoniazid is a widely used anti-tuberculosis medication. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique components of mycobacterial cell wall.

DRUG

Rifampicin

Rifampicin is a widely used anti-tuberculosis medication.

DRUG

Pyrazinamide

Pyrazinamide is a commonly used medication for tuberculosis, with bactericidal effect against intracellular mycobacterium tuberculosis.

DRUG

Ethambutol

Ethambutol is a widely used medicine in anti-TB regimens with bacteriostatic effect against M. tb.

DRUG

Levofloxacin

Levofloxacin is a commonly used antimicrobial for TB and other infections, which acts on the DNA-DNA-gyrase complex and topoisomerase IV. It is the S (-) enantiomer of the racemic active substance ofloxacin.

Sponsors & Collaborators

• Hubei Provincial Center for Disease Control and Prevention

  collaborator OTHER

• Centre for Tuberculosis Control of Guangdong Province

  collaborator UNKNOWN

• Hunan Institute For Tuberculosis Control

  collaborator UNKNOWN

• Anhui Chest Hospital

  collaborator OTHER

• Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

  collaborator OTHER_GOV

• Wuhan Institute for Tuberculosis Control

  collaborator OTHER

• Shanghai Pulmonary Hospital, Shanghai, China

  collaborator OTHER

• Shenyang Chest Hospital

  collaborator OTHER

• Changchun Infectious Disease Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Public Health Clinical Center of Chengdu

  collaborator UNKNOWN

• Taiyuan Fourth People's Hospital

  collaborator UNKNOWN

• The Sixth People's Hospital of Nantong

  collaborator UNKNOWN

• The Tuberculosis Prevention and Treatment Hospital of Shanxi Province

  collaborator UNKNOWN

• Beijing Research Institute for Tuberculosis Control

  collaborator UNKNOWN

• Infectious Disease Prevention Hospital in Heilongjiang Province

  collaborator UNKNOWN

• The Third People's Hospital of Zhenjiang

  collaborator UNKNOWN

• Tianjin centers for Disease Control and Prevention

  collaborator UNKNOWN

• Harbin Chest Hospital

  collaborator UNKNOWN

• Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC

  collaborator UNKNOWN

• Heilongjiang Province center for tuberculosis Control and Prevention

  collaborator UNKNOWN

• Tianjin Haihe Hospital

  collaborator OTHER

• The Infectious Disease Hospital of Wangkai Zaozhuang

  collaborator UNKNOWN

• The Third People's Hospital of Kunming City

  collaborator UNKNOWN

• Kaifeng Central Hospital

  collaborator OTHER

• The Infectious Hospital of Hebi

  collaborator UNKNOWN

• Pulmonary Hospital of Lanzhou

  collaborator UNKNOWN

• The Fourth People's Hospital of Ningxia Autonomous Region

  collaborator UNKNOWN

• The Fourth People's Hospital of Qinghai Province

  collaborator OTHER

• The Fifth People's Hospital of Suzhou

  collaborator OTHER

• Chongqing Infectious Disease Medical Center

  collaborator UNKNOWN

• Tuberculosis Hospital in Jilin Province

  collaborator UNKNOWN

• Sixth People's Hospital of Nanyang City

  collaborator UNKNOWN

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Beijing Chest Hospital

  lead OTHER

Principal Investigators

• Shenjie Tang, MD · Beijing Chest Hospital

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

2016-08-31

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• China

Study Locations