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Trial record 13 of 27 for:    levofloxacin tuberculosis

Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis

This study is currently recruiting participants.
Verified March 2017 by Tang Shenjie, Beijing Chest Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02901288
First Posted: September 15, 2016
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Hubei Provincial Center for Disease Control and Prevention
Centre for Tuberculosis Control of Guangdong Province
Hunan Institute For Tuberculosis Control
Anhui Chest Hospital
Guangxi Center for Disease Prevention and Control
Wuhan Institute for Tuberculosis Control
Shanghai Pulmonary Hospital, Shanghai, China
China Shenyang Chest Hospital
Changchun Infectious Disease Hospital
First Affiliated Hospital of Xinjiang Medical University
Public Health Clinical Center of Chengdu
Taiyuan Fourth People's Hospital
The Sixth People's Hospital of Nantong
The Tuberculosis Prevention and Treatment Hospital of Shanxi Province
Beijing Research Institute for Tuberculosis Control
Infectious Disease Prevention Hospital in Heilongjiang Province
The Third People's Hospital of Zhenjiang
Tianjin centers for Disease Control and Prevention
Harbin Chest Hospital
Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC
Heilongjiang Province center for tuberculosis Control and Prevention
Tianjin Haihe Hospital
The Infectious Disease Hospital of Wangkai Zaozhuang
The Third People's Hospital of Kunming City
Kaifeng Pulmonary Disease Hospital
The Infectious Hospital of Hebi
Pulmonary Hospital of Lanzhou
The Fourth People's Hospital of Ningxia Autonomous Region
The 4th People's Hospital of Qinghai Province
The Fifth People's Hospital of Suzhou
Chongqing Infectious Disease Medical Center
Tuberculosis Hospital in Jilin Province
Sixth People's Hospital of Nanyang City
Wuhan medical treatment center
Information provided by (Responsible Party):
Tang Shenjie, Beijing Chest Hospital
  Purpose
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.

Condition Intervention Phase
Tuberculosis, Pulmonary Drug: Isoniazid Drug: Rifampicin Drug: Pyrazinamide Drug: Ethambutol Drug: Levofloxacin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shortened Regimens for First Diagnosed Smear Positive Drug Susceptible Pulmonary Tuberculosis: a Randomised Controlled Non-inferiority Trial

Resource links provided by NLM:


Further study details as provided by Tang Shenjie, Beijing Chest Hospital:

Primary Outcome Measures:
  • The percentage of participants with TB recurrence/relapse by 24 months after the end of treatment. [ Time Frame: 24 months after treatment completion for all 3 groups ]
  • Percentage of participants with treatment failure at either 4.5 months or 6 months after randomization. [ Time Frame: 4.5 months after randomization for experimental group1 and 2; 6 months after randomization for control group ]

Secondary Outcome Measures:
  • Treatment adverse reactions occuring [ Time Frame: An average of 6 months for control group and 4.5 months for experimental group1 and 2 during treatment and 24 months after treatment completion. ]
  • Time to sputum smear or culture conversion within intensive phase . [ Time Frame: An avergae of 2-3 months after randomization. ]
  • Sputum smear or culture conversion proportion at the treatment completion. [ Time Frame: An average of 6 months for control group while 4.5 months for experimental group 1 and 2. ]
  • Radiological manifestation change of TB lesion or cavity. [ Time Frame: An average of 6 months during treatment and 24 months after treatment completion. ]
  • Patiens adherence rate [ Time Frame: An average of 6 months during treatment and 24 months after treatment completion. ]

Estimated Enrollment: 3900
Study Start Date: August 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental group1

The experimental group1 all oral regimen is consisted of isoniazid,rifampin, pyrazinamide, ethambutol and levofloxacin for 4.5 months.

Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg((less than 50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less than 50kg,once daily) or 1000mg (more than 50kg,once daily), levofloxacin 600mg(less than 50kg,given once daily) or 800mg(more than 50kg,once daily).

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.
Other Name: Cravit
Experimental: experimental group2
The experimental group2 all oral regimen consisted of isoniazid,rifampin, pyrazinamide, and ethambutol for 4.5 months. The dosage of isoniazid,rifampin, pyrazinamide, and ethambutol is as same as that of control regimen.
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.
Active Comparator: Control regimen group

The control all oral regimen consisted of isoniazid,rifampin, pyrazinamide, and ethambutol during the intensive phase of treatment (2 months), followed by isoniazid and rifampin during the continuation phase (4 months).

Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg((less than 50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less than 50kg,once daily) or 1000mg (more than 50kg,once daily).

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.

Detailed Description:
  1. Design: The study is a multi-center, randomized,controlled non-inferiority trial.
  2. Population: patients with newly diagnosed drug-susceptible pulmonary TB who fulfill the inclusion and exclusion criteria.
  3. Investigational regimens:

    Experimental group 1 regimen consists of levofloxacin, isoniazid , rifampicin,ethambutol and pyrazinamide for 4.5 months.

    Experimental group 2 regimen consists of isoniazid, rifampicin, ethambutol and pyrazinamide for 4.5 months.

    The control group is WHO recommended regimen conmposed of isoniazid , rifampicin, ethambutol and pyrazinamide for 2 months, followed by isoniazid , rifampicin for 4 months.

    Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg(less than 50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less than 50kg,once daily) or 1000mg (more than 50kg,once daily), levofloxacin 600mg(less than 50kg,given once daily) or 800mg(more than 50kg,once daily)..

  4. Trial objectives: to evaluate that shortened regimens is not inferior to standard treatment in terms of efficacy and safety for new smear positive pulmonary TB patients.
  5. Primary and Secondary outcome measures:

    The primary efficacy outcome measures include (a)the percentage of participants with TB recurrence/relapse by 24 months after the end of treatment;(b) percentage of participants with treatment failure at either 4.5 months or 6 months after randomization. (a) Time to sputum smear or culture conversion within intensive phase.(b) Sputum smear conversion proportion at the treatment completion. (c) Number of adverse drug reaction occurring during treatment or follow-up period. (d) Radiological manifestation change of TB lesion or cavity.(e) Patients adherence rate.

  6. Sample Size:

    Approximately 3900 participants will be enrolled and randomized with 1:1:1 ratio into either Experimental group1, Experimental group2 or control group.

  7. Blinding:

    The study is an open-label study.

  8. Assessment and follow-up:

All patients will be followed by to 2 years after completion of treatment.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate).
  2. Is aged 18-65 years.
  3. Has twice positive acid-fast bacilli(AFB) sputum smear or positive sputum culture result, along with chest x-ray imaging consistent with active pulmonary tuberculosis.
  4. Newly diagnosed cases receiving anti-TB treatment for less than one month
  5. Urine Human Chorionic Gonadotropin(U-HCG) negative and must agree to use effective contraception during the trial period.
  6. Has Alanine aminotransferase(ALT)and Total bilirubin(TBil) less than 2 times the upper limit of normal ; has Creatinine clearance rate (CrCI) more than 30ml/min; has Hemoglobin more than 7.0g/dL; has Platelet(PLT)more than 50 x10^9/L before study entry.

Exclusion Criteria:

  1. Concomitant severe cardiovascular, liver, kidney, nervous system, hematopoietic system and other diseases, or concomitant neoplastic diseases. Or extensive lesion with respiratory insufficiency.
  2. Uncontrolled diabetes mellitus.
  3. Concomitant mental disorders.
  4. Is HIV positive.
  5. Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study.
  6. Is known to be pregnant or breast-feeding.
  7. Is unable or unwilling to comply with the treatment, assessment, or follow-up schedule.
  8. Is taking any medications contraindicated with the medicines in any trial regimen of the study.
  9. Has a known allergy to any drug of treatment regimens.
  10. Is currently taking part in another trial.
  11. Has a QTc interval more than 480ms.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901288


Contacts
Contact: Shenjie Tang, MD tangsj1106@sina.com

  Show 35 Study Locations
Sponsors and Collaborators
Beijing Chest Hospital
Hubei Provincial Center for Disease Control and Prevention
Centre for Tuberculosis Control of Guangdong Province
Hunan Institute For Tuberculosis Control
Anhui Chest Hospital
Guangxi Center for Disease Prevention and Control
Wuhan Institute for Tuberculosis Control
Shanghai Pulmonary Hospital, Shanghai, China
China Shenyang Chest Hospital
Changchun Infectious Disease Hospital
First Affiliated Hospital of Xinjiang Medical University
Public Health Clinical Center of Chengdu
Taiyuan Fourth People's Hospital
The Sixth People's Hospital of Nantong
The Tuberculosis Prevention and Treatment Hospital of Shanxi Province
Beijing Research Institute for Tuberculosis Control
Infectious Disease Prevention Hospital in Heilongjiang Province
The Third People's Hospital of Zhenjiang
Tianjin centers for Disease Control and Prevention
Harbin Chest Hospital
Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC
Heilongjiang Province center for tuberculosis Control and Prevention
Tianjin Haihe Hospital
The Infectious Disease Hospital of Wangkai Zaozhuang
The Third People's Hospital of Kunming City
Kaifeng Pulmonary Disease Hospital
The Infectious Hospital of Hebi
Pulmonary Hospital of Lanzhou
The Fourth People's Hospital of Ningxia Autonomous Region
The 4th People's Hospital of Qinghai Province
The Fifth People's Hospital of Suzhou
Chongqing Infectious Disease Medical Center
Tuberculosis Hospital in Jilin Province
Sixth People's Hospital of Nanyang City
Wuhan medical treatment center
Investigators
Principal Investigator: Shenjie Tang, MD Beijing Chest Hospital
  More Information

Responsible Party: Tang Shenjie, Director, TB Department, Beijing Chest Hospital
ClinicalTrials.gov Identifier: NCT02901288     History of Changes
Other Study ID Numbers: 2015ZX10003001
First Submitted: September 2, 2016
First Posted: September 15, 2016
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tang Shenjie, Beijing Chest Hospital:
pulmonary tuberculosis
shortened regimen
clinical trial

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Levofloxacin
Ofloxacin
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Rifampin
Isoniazid
Pyrazinamide
Ethambutol
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors