Pulmonary Tuberculosis Clinical Trial
Official title:
A Prospective, Randomized Controlled Study for the Efficacy and Safety of the Substitution of Pyrazinamide and Ethambutol With Moxifloxacin During the Intensive Phase of Treatment of Pulmonary Tuberculosis
This study aims to find an optimized initial regimen for pulmonary tuberculosis(PTB), evaluating the efficacy, safety and acceptability of isoniazid, rifampicin and moxifloxacin(HRM) for the intensive phase of initial therapy of PTB, compared with the standard initial regimen.
Status | Not yet recruiting |
Enrollment | 286 |
Est. completion date | February 1, 2024 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Aged 18 years or over, and an individual who completely bear the ability of civil actions. - New cases of pulmonary tuberculosis. No previous anti-tuberculosis therapy or cumulatively taking anti-tuberculosis drugs for less than 1 month. - Pulmonary tuberculosis patients with bacteriological diagnosis. Exclusion Criteria: - Suffering from tuberculous pleurisy. - Patients with extrapulmonary tuberculosis. - Renal insufficiency patients with creatinine clearance rate <30 ml/min. - Abnormal liver function (ALT and/or AST and/or TBIL greater than 2 times the upper limit of normal) or decompensated cirrhosis. - HIV-Ab positive. - Psychiatric patients, or have a previous history of mental illness, or recently have obvious anxiety or depression and other mental abnormalities. - Patients receiving immunosuppressive therapy. - Pregnant or breast feeding. - Diabetes. - X-pert MTB/RIF test of sputum or alveolar lavage fluid showed that Mycobacterium tuberculosis was rifampin resistant. - Moxifloxacin was used within 14 days before entering the group. - Anti-tuberculosis treatment has been started and drugs are being taken before entering the group. - QT interval extension > 480 ms. - Combined with serious cardiovascular, liver, kidney, nervous system, blood system and other diseases or tumor diseases. - Pulmonary lesions are widespread with respiratory insufficiency. - Any other circumstances in which the anti-tuberculosis scheme of the experimental group or the control group cannot be selected for treatment. |
Country | Name | City | State |
---|---|---|---|
China | The Fifth Affiliated Hospital Sun Yat-Sen University | Zhuhai | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Fifth Affiliated Hospital, Sun Yat-Sen University |
China,
Chakraborty S, Rhee KY. Tuberculosis Drug Development: History and Evolution of the Mechanism-Based Paradigm. Cold Spring Harb Perspect Med. 2015 Apr 15;5(8):a021147. doi: 10.1101/cshperspect.a021147. Review. — View Citation
Egelund EF, Alsultan A, Peloquin CA. Optimizing the clinical pharmacology of tuberculosis medications. Clin Pharmacol Ther. 2015 Oct;98(4):387-93. doi: 10.1002/cpt.180. Epub 2015 Jul 22. Review. — View Citation
Gillespie SH, Crook AM, McHugh TD, Mendel CM, Meredith SK, Murray SR, Pappas F, Phillips PP, Nunn AJ; REMoxTB Consortium. Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med. 2014 Oct 23;371(17):1577-87. doi: 10.1056/NEJMoa1407426. Epub 2014 Sep 7. — View Citation
Lange C, Chesov D, Heyckendorf J, Leung CC, Udwadia Z, Dheda K. Drug-resistant tuberculosis: An update on disease burden, diagnosis and treatment. Respirology. 2018 Jul;23(7):656-673. doi: 10.1111/resp.13304. Epub 2018 Apr 11. Review. — View Citation
Pasipanodya JG, Gumbo T. A meta-analysis of self-administered vs directly observed therapy effect on microbiologic failure, relapse, and acquired drug resistance in tuberculosis patients. Clin Infect Dis. 2013 Jul;57(1):21-31. doi: 10.1093/cid/cit167. Epub 2013 Mar 13. Erratum in: Clin Infect Dis. 2013 Oct;57(8):1223. — View Citation
Pienaar E, Sarathy J, Prideaux B, Dietzold J, Dartois V, Kirschner DE, Linderman JJ. Comparing efficacies of moxifloxacin, levofloxacin and gatifloxacin in tuberculosis granulomas using a multi-scale systems pharmacology approach. PLoS Comput Biol. 2017 Aug 17;13(8):e1005650. doi: 10.1371/journal.pcbi.1005650. eCollection 2017 Aug. — View Citation
Tiberi S, du Plessis N, Walzl G, Vjecha MJ, Rao M, Ntoumi F, Mfinanga S, Kapata N, Mwaba P, McHugh TD, Ippolito G, Migliori GB, Maeurer MJ, Zumla A. Tuberculosis: progress and advances in development of new drugs, treatment regimens, and host-directed therapies. Lancet Infect Dis. 2018 Jul;18(7):e183-e198. doi: 10.1016/S1473-3099(18)30110-5. Epub 2018 Mar 23. Review. Erratum in: Lancet Infect Dis. 2018 Apr 27;:. — View Citation
Xu P, Chen H, Xu J, Wu M, Zhu X, Wang F, Chen S, Xu J. Moxifloxacin is an effective and safe candidate agent for tuberculosis treatment: a meta-analysis. Int J Infect Dis. 2017 Jul;60:35-41. doi: 10.1016/j.ijid.2017.05.003. Epub 2017 May 8. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of adverse outcomes | Adverse outcomes: A sum of treatment failure and relapse. Treatment failure: A patient whose sputum smear or culture is positive at 5 months or later during treatment. Relapse: patients with successful treatment show one of the following conditions at any time point during the observation period of drug withdrawal: 1) Sputum or Bronchoalveolar lavage fluid(BALF)culture positive, 2) Sputum or BALF acid fast stain and/or Xpert positive with active PTB evidence in CT scan. |
18 months (within one year of completion of therapy) | |
Secondary | The rate of Treatment success | Treatment success: A sum of cured and completed treatment. Cure: A patient whose sputum smear or culture was positive at the beginning of the treatment but who was smear- or culture-negative in the last month of treatment and on at least one previous occasion. Treatment completed: A patient who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least one previous occasion. |
the 2nd, 3rd, 5th and 6th months | |
Secondary | The rate of sputum Mtb negative conversion | Sputum Mtb negative conversion: two negative-culture results at different visits without an intervening positive result, or no sputum could be tested after once negative-culture. | the 2nd, 3rd, 5th and 6th months | |
Secondary | The time of sputum Mtb negative conversion | The first time of sputum Mtb negative conversion | the 2nd, 3rd, 5th and 6th months | |
Secondary | Number of Patients With Adverse Events | The number of participants includes all patients who had adverse event. | 18 months (within one year of completion of therapy) |
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