Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment
NCT ID: NCT05454345
Last Updated: 2022-07-12
Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE3
620 participants
INTERVENTIONAL
2022-10-01
2026-06-30
Brief Summary
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Detailed Description
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2. Persons with positive culture results for M. tuberculosis or smear-positive sputum(spoligotyping isolates genetically identified as M. tuberculosis).
3. Data collected pre-study included written informed consent; patients assessed for eligibility; height and weight; clinical symptoms of TB; adjunctive therapy; adverse drug reaction; blood and urine routine; liver and kidney function; acid-fast staining; single M. tuberculosis strain isolated from one patient with TB; GeneXpert MTB/RIF; chest CT scans
4. Clinical symptoms of TB: cough, expectoration, hemoptysis, chest pain, fever, shortness of breath, weak.
5. All patients should review for Xpert MTB/RIF assay in the second week.
6. During treatment, clinical symptoms of TB and body weights takes weekly; blood and urine routine in weeks 1,2,4,8,13; Sputum smears and culture were routinely in weeks 1,2,4,8,13, and months 6 and 12. TB Disease-free Survival at six or twelve months after study treatment assignment as the secondary outcome measures.
7. TB patients were identified through bacteriological confirmation (smear-positive and/or culture-positive).
8. Pulmonary TB patients showed manifestation of tuberculosis by chest CT scans or X-ray.
9. Adverse events of the treatment: neurological diseases, blood system diseases; diseases of the circulatory system; respiratory diseases; digestive diseases; extra-pulmonary TB; diabetes; arthralgia; mental disorders; hemoptysis and pneumothorax; pulmonary embolism; skin rash.
10. Management of a participant with a positive sputum culture for M. tuberculosis at or after week 13: A second sputum sample was collected on the following day for a second culture. If M. tuberculosis is isolated in culture, drug susceptibility testing should be performed on one isolate. Patients will re-evaluate symptoms and chest CT scans; sputum was performed in triplicates and repeated for validation. These patients could restart the standard six-month regimen at any time.
11. Patients follow up one week after the completion of treatment and 6,12,18 months after treatment is over. Patients undergo regular follow-up with sputum smear tests or imaging studies. Patients with positive TB symptom screen or suspected TB patients based on imaging tests are recommended with research staff.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin-containing regimen
Thirteen weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin.
Sitafloxacin
In our Intervention group, sitafloxacin replace the ethambutol, 200mg/d
Pyrazinamide
Pyrazinamide is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 2000mg (20-30mg/kg/d)
Rifapentine
In our Intervention group, rifapentine replace rifampin, 600mg/d
Isoniazid
Isoniazid is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 300mg (4-6mg/kg/d)
The three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin&SMZ/TMP-containing regimen
Six weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin, followed by seven weeks of daily treatment with rifapentine, isoniazid, ,SMZ/TMP and Sitafloxacin.
Sitafloxacin
In our Intervention group, sitafloxacin replace the ethambutol, 200mg/d
SMZ/TMP
In our The three-month Rifapentine\&Isoniazid\&Pyrazinamide\&Sitafloxacin\&SMZ/TMP-containing regimen, Six weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin, followed by seven weeks of daily treatment with rifapentine, isoniazid, ,SMZ/TMP and Sitafloxacin, SMZ 80mg/kg/d, TMP16mg/kg/d
Pyrazinamide
Pyrazinamide is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 2000mg (20-30mg/kg/d)
Rifapentine
In our Intervention group, rifapentine replace rifampin, 600mg/d
Isoniazid
Isoniazid is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 300mg (4-6mg/kg/d)
The six-month standard Rifampin&Isoniazid&Pyrazinamide&Ethambutol-containing regimen
Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid.
Rifampin
Rifampin is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, Rifampin 600mg (8-12mg/kg/d)
Pyrazinamide
Pyrazinamide is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 2000mg (20-30mg/kg/d)
Isoniazid
Isoniazid is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 300mg (4-6mg/kg/d)
Ethambutol
Ethambutol is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 1200mg (15-25mg/kg/d)
The four-month Rifapentine&Isoniazid&Pyrazinamide&Moxifloxacin -containing regimen
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin.
Rifapentine
In our Intervention group, rifapentine replace rifampin, 600mg/d
Isoniazid
Isoniazid is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 300mg (4-6mg/kg/d)
Ethambutol
Ethambutol is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 1200mg (15-25mg/kg/d)
Moxifloxacin
Moxifloxacin is a fourth-generation fluoroquinolone with potent activity against M. tuberculosis in vitro and in vivo, 400mg (7.5-10mg/kg/d)
Interventions
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Sitafloxacin
In our Intervention group, sitafloxacin replace the ethambutol, 200mg/d
SMZ/TMP
In our The three-month Rifapentine\&Isoniazid\&Pyrazinamide\&Sitafloxacin\&SMZ/TMP-containing regimen, Six weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin, followed by seven weeks of daily treatment with rifapentine, isoniazid, ,SMZ/TMP and Sitafloxacin, SMZ 80mg/kg/d, TMP16mg/kg/d
Rifampin
Rifampin is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, Rifampin 600mg (8-12mg/kg/d)
Pyrazinamide
Pyrazinamide is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 2000mg (20-30mg/kg/d)
Rifapentine
In our Intervention group, rifapentine replace rifampin, 600mg/d
Isoniazid
Isoniazid is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 300mg (4-6mg/kg/d)
Ethambutol
Ethambutol is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 1200mg (15-25mg/kg/d)
Moxifloxacin
Moxifloxacin is a fourth-generation fluoroquinolone with potent activity against M. tuberculosis in vitro and in vivo, 400mg (7.5-10mg/kg/d)
Eligibility Criteria
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Inclusion Criteria
2. At least one sputum specimen is positive for acid-fast bacilli or positive results of sputum culture on smear microscopy(species identification as M. tuberculosis) or at least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing.
3. Phenotypic drug susceptibility testing indicates the patient's isolate is susceptible to rifampin, isoniazid, pyrazinamide, ethambutol, rifapentine, moxifloxacin, and Sitafloxacin.
4. Patients have written informed consent.
Exclusion Criteria
2. HIV-positive individuals, steroid-dependent and those on steroid treatment.
3. Autoimmune diseases, severe hepatic or renal dysfunction, psychosis, hematological malignancies, cancer, diabetes individuals.
4. Known allergy to one or more of the study drugs.
5. Women who are currently pregnant or breast-feeding.
6. Patients who received any investigational drug in the past three months.
7. The patients refused treatment with medications
8. Mycobacterium tuberculosis/nontuberculous mycobacterium co-infection.
9. In the investigator's judgment, other medical conditions that are not in the individual's best interest to participate.
18 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Zhang Ying
Prof, MD
References
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Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis: 2011 Update. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK148644/
Gupta VK, Kumar MM, Singh D, Bisht D, Sharma S. Drug targets in dormant Mycobacterium tuberculosis: can the conquest against tuberculosis become a reality? Infect Dis (Lond). 2018 Feb;50(2):81-94. doi: 10.1080/23744235.2017.1377346. Epub 2017 Sep 21.
Burman WJ, Gallicano K, Peloquin C. Comparative pharmacokinetics and pharmacodynamics of the rifamycin antibacterials. Clin Pharmacokinet. 2001;40(5):327-41. doi: 10.2165/00003088-200140050-00002.
Dorman SE, Nahid P, Kurbatova EV, Phillips PPJ, Bryant K, Dooley KE, Engle M, Goldberg SV, Phan HTT, Hakim J, Johnson JL, Lourens M, Martinson NA, Muzanyi G, Narunsky K, Nerette S, Nguyen NV, Pham TH, Pierre S, Purfield AE, Samaneka W, Savic RM, Sanne I, Scott NA, Shenje J, Sizemore E, Vernon A, Waja Z, Weiner M, Swindells S, Chaisson RE; AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. N Engl J Med. 2021 May 6;384(18):1705-1718. doi: 10.1056/NEJMoa2033400.
Keating GM. Sitafloxacin: in bacterial infections. Drugs. 2011 Apr 16;71(6):731-44. doi: 10.2165/11207380-000000000-00000.
Yamaguchi K, Ohno A, Ishii Y, Tateda K, Iwata M, Kanda M, Akizawa K, Shimizu C, Kon S, Nakamura K, Matsuda K, Tominaga M, Nakagawa T, Sugita A, Ito T, Kato J, Suwabe A, Yamahata K, Kawamura C, Tashiro H, Horiuchi H, Katayama Y, Kondou S, Misawa S, Murata M, Kobayashi Y, Okamoto H, Yamazaki K, Okada M, Haruki K, Kanno H, Aihara M, Maesaki S, Hashikita G, Miyajima E, Sumitomo M, Saito T, Yamane N, Kawashima C, Akiyama T, Ieiri T, Yamamoto Y, Okamoto Y, Okabe H, Moro K, Shigeta M, Yoshida H, Yamashita M, Hida Y, Takubo T, Kusakabe T, Masaki H, Heijyou H, Nakaya H, Kawahara K, Sano R, Matsuo S, Kono H, Yuzuki Y, Ikeda N, Idomuki M, Soma M, Yamamoto G, Kinoshita S, Kawano S, Oka M, Kusano N, Kang D, Ono J, Yasujima M, Miki M, Hayashi M, Okubo S, Toyoshima S, Kaku M, Sekine I, Shiotani J, Horiuchi H, Tazawa Y, Yoneyama A, Kumasaka K, Koike K, Taniguchi N, Ozaki Y, Uchida T, Murakami M, Inuzuka K, Gonda H, Yamaguchi I, fujimoto Y, Iriyama J, Asano Y, Genma H, Maekawa M, Yoshimura H, Nakatani K, Baba H, Ichiyama S, Fujita S, Kuwabara M, Okazaki T, Fujiwara H, Ota H, Nagai A, Fujita J, Negayama K, Sugiura T, Kamioka M, Murase M, Yamane N, Nakasone I, Okayama A, Aoki Y, Kusaba K, Nakashima Y, Miyanohara H, Hiramatsu K, Saikawa T, Yanagihara K, Matsuda J, Kohno S, Mashiba K. [In vitro susceptibilities to levofloxacin and various antibacterial agents of 12,919 clinical isolates obtained from 72 centers in 2007]. Jpn J Antibiot. 2009 Aug;62(4):346-70. Japanese.
Asakura T, Suzuki S, Fukano H, Okamori S, Kusumoto T, Uwamino Y, Ogawa T, So M, Uno S, Namkoong H, Yoshida M, Kamata H, Ishii M, Nishimura T, Hoshino Y, Hasegawa N. Sitafloxacin-Containing Regimen for the Treatment of Refractory Mycobacterium avium Complex Lung Disease. Open Forum Infect Dis. 2019 Mar 7;6(4):ofz108. doi: 10.1093/ofid/ofz108. eCollection 2019 Apr.
Ito S, Yasuda M, Seike K, Sugawara T, Tsuchiya T, Yokoi S, Nakano M, Deguchi T. Clinical and microbiological outcomes in treatment of men with non-gonococcal urethritis with a 100-mg twice-daily dose regimen of sitafloxacin. J Infect Chemother. 2012 Jun;18(3):414-8. doi: 10.1007/s10156-012-0392-9. Epub 2012 Feb 28.
Mori H, Suzuki H, Matsuzaki J, Masaoka T, Kanai T. 10-Year Trends in Helicobacter pylori Eradication Rates by Sitafloxacin-Based Third-Line Rescue Therapy. Digestion. 2020;101(5):644-650. doi: 10.1159/000501610. Epub 2019 Aug 6.
Li Y, Zhu D, Peng Y, Tong Z, Ma Z, Xu J, Sun S, Tang H, Xiu Q, Liang Y, Wang X, Lv X, Dai Y, Zhu Y, Qu Y, Xu K, Huang Y, Wu S, Lai G, Li X, Han X, Yang Z, Sheng J, Liu Z, Li H, Chen Y, Zhu H, Zhang Y. A randomized, controlled, multicenter clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus moxifloxacin in adult patients with community-acquired pneumonia. Curr Med Res Opin. 2021 Apr;37(4):693-701. doi: 10.1080/03007995.2021.1885362. Epub 2021 Feb 22.
Leechawengwongs M, Prammananan T, Jaitrong S, Billamas P, Makhao N, Thamnongdee N, Thanormchat A, Phurattanakornkul A, Rattanarangsee S, Ratanajaraya C, Disratthakit A, Chaiprasert A. In Vitro Activity and MIC of Sitafloxacin against Multidrug-Resistant and Extensively Drug-Resistant Mycobacterium tuberculosis Isolated in Thailand. Antimicrob Agents Chemother. 2017 Dec 21;62(1):e00825-17. doi: 10.1128/AAC.00825-17. Print 2018 Jan.
Kamada K, Yoshida A, Iguchi S, Arai Y, Uzawa Y, Konno S, Shimojima M, Kikuchi K. Nationwide surveillance of antimicrobial susceptibility of 509 rapidly growing mycobacteria strains isolated from clinical specimens in Japan. Sci Rep. 2021 Jun 9;11(1):12208. doi: 10.1038/s41598-021-91757-4.
Yi L, Aono A, Chikamatsu K, Igarashi Y, Yamada H, Takaki A, Mitarai S. In vitro activity of sitafloxacin against Mycobacterium tuberculosis with gyrA/B mutations isolated in Japan. J Med Microbiol. 2017 Jun;66(6):770-776. doi: 10.1099/jmm.0.000493.
Suzuki Y, Nakajima C, Tamaru A, Kim H, Matsuba T, Saito H. Sensitivities of ciprofloxacin-resistant Mycobacterium tuberculosis clinical isolates to fluoroquinolones: role of mutant DNA gyrase subunits in drug resistance. Int J Antimicrob Agents. 2012 May;39(5):435-9. doi: 10.1016/j.ijantimicag.2012.01.007. Epub 2012 Mar 13.
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Other Identifiers
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yzhang207
Identifier Type: -
Identifier Source: org_study_id
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