Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis
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| ClinicalTrials.gov Identifier: NCT02901288 |
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Recruitment Status : Unknown
Verified March 2017 by Tang Shenjie, Beijing Chest Hospital.
Recruitment status was: Recruiting
First Posted : September 15, 2016
Last Update Posted : March 20, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tuberculosis, Pulmonary | Drug: Isoniazid Drug: Rifampicin Drug: Pyrazinamide Drug: Ethambutol Drug: Levofloxacin | Phase 4 |
- Design: The study is a multi-center, randomized,controlled non-inferiority trial.
- Population: patients with newly diagnosed drug-susceptible pulmonary TB who fulfill the inclusion and exclusion criteria.
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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)..
- 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.
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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.
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Sample Size:
Approximately 3900 participants will be enrolled and randomized with 1:1:1 ratio into either Experimental group1, Experimental group2 or control group.
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Blinding:
The study is an open-label study.
- Assessment and follow-up:
All patients will be followed by to 2 years after completion of treatment.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3900 participants |
| 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 |
| Study Start Date : | August 2016 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2018 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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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.
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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. |
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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. |
- 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 ]
- 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. ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
- Is aged 18-65 years.
- 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.
- Newly diagnosed cases receiving anti-TB treatment for less than one month
- Urine Human Chorionic Gonadotropin(U-HCG) negative and must agree to use effective contraception during the trial period.
- 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:
- Concomitant severe cardiovascular, liver, kidney, nervous system, hematopoietic system and other diseases, or concomitant neoplastic diseases. Or extensive lesion with respiratory insufficiency.
- Uncontrolled diabetes mellitus.
- Concomitant mental disorders.
- Is HIV positive.
- Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study.
- Is known to be pregnant or breast-feeding.
- Is unable or unwilling to comply with the treatment, assessment, or follow-up schedule.
- Is taking any medications contraindicated with the medicines in any trial regimen of the study.
- Has a known allergy to any drug of treatment regimens.
- Is currently taking part in another trial.
- Has a QTc interval more than 480ms.
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
| Contact: Shenjie Tang, MD | tangsj1106@sina.com |
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| Principal Investigator: | Shenjie Tang, MD | Beijing Chest Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tang Shenjie, Director, TB Department, Beijing Chest Hospital |
| ClinicalTrials.gov Identifier: | NCT02901288 History of Changes |
| Other Study ID Numbers: |
2015ZX10003001 |
| First Posted: | September 15, 2016 Key Record Dates |
| Last Update Posted: | March 20, 2017 |
| Last Verified: | March 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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pulmonary tuberculosis shortened regimen clinical trial |
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Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Levofloxacin Ofloxacin 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 |