drugset / Trial / NCT01298336
Treatment of Mycobacterium Xenopi Pulmonary Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary infection.
Timeline
- Start
- 2011-03-02
- Primary completion
- 2019-03
- Completion
- 2019-03
Publications
- Background Song JH, Yoon SY, Park TY, Heo EY, Kim DK, Chung HS, Lee JK. The clinical impact of drug-induced hepatotoxicity on anti-tuberculosis therapy: a case control study. Respir Res. 2019 Dec 16;20(1):283. doi: 10.1186/s12931-019-1256-y.
- Background TIMPE A, RUNYON EH. The relationship of atypical acid-fast bacteria to human disease; a preliminary report. J Lab Clin Med. 1954 Aug;44(2):202-9. No abstract available.
- Background RUNYON EH. Anonymous mycobacteria in pulmonary disease. Med Clin North Am. 1959 Jan;43(1):273-90. doi: 10.1016/s0025-7125(16)34193-1. No abstract available.
- Background Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. doi: 10.1164/rccm.200604-571ST. No abstract available.
- Background Falkinham JO 3rd. Nontuberculous mycobacteria in the environment. Clin Chest Med. 2002 Sep;23(3):529-51. doi: 10.1016/s0272-5231(02)00014-x.
- Background von Reyn CF, Waddell RD, Eaton T, Arbeit RD, Maslow JN, Barber TW, Brindle RJ, Gilks CF, Lumio J, Lahdevirta J, et al. Isolation of Mycobacterium avium complex from water in the United States, Finland, Zaire, and Kenya. J Clin Microbiol. 1993 Dec;31(12):3227-30. doi: 10.1128/jcm.31.12.3227-3230.1993.
- Background Smith MJ, Citron KM. Clinical review of pulmonary disease caused by Mycobacterium xenopi. Thorax. 1983 May;38(5):373-7. doi: 10.1136/thx.38.5.373.
- Background Banks J, Hunter AM, Campbell IA, Jenkins PA, Smith AP. Pulmonary infection with mycobacterium xenopi: review of treatment and response. Thorax. 1984 May;39(5):376-82. doi: 10.1136/thx.39.5.376.
- Background American Thoracic Society. Diagnosis standards and classification of tuberculosis and other mycobacterial diseases. New York: American Lung Association, 1974:25
- Background Diagnosis and treatment of disease caused by nontuberculous mycobacteria. Am Rev Respir Dis. 1990 Oct;142(4):940-53. doi: 10.1164/ajrccm/142.4.940. No abstract available.
- Background Diagnosis and treatment of disease caused by nontuberculous mycobacteria. This official statement of the American Thoracic Society was approved by the Board of Directors, March 1997. Medical Section of the American Lung Association. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 2):S1-25. doi: 10.1164/ajrccm.156.2.atsstatement.
- Background Subcommittee OT. Management of opportunist mycobacterial infections: Joint Tuberculosis Committee Guidelines 1999. Subcommittee of the Joint Tuberculosis Committee of the British Thoracic Society. Thorax. 2000 Mar;55(3):210-8. doi: 10.1136/thorax.55.3.210. No abstract available.
- Background Dailloux M, Abalain ML, Laurain C, Lebrun L, Loos-Ayav C, Lozniewski A, Maugein J; French Mycobacteria Study Group. Respiratory infections associated with nontuberculous mycobacteria in non-HIV patients. Eur Respir J. 2006 Dec;28(6):1211-5. doi: 10.1183/09031936.00063806.
- Background Jenkins PA, Campbell IA; Research Committee of The British Thoracic Society. Pulmonary disease caused by Mycobacterium xenopi in HIV-negative patients: five year follow-up of patients receiving standardised treatment. Respir Med. 2003 Apr;97(4):439-44. doi: 10.1053/rmed.2002.1444.
- Background Baugnee PE, Pouthier F, Delaunois L. [Pulmonary mycobacteriosis due to Mycobacterium xenopi" in-vitro sensitivity to classical antitubercular agents and clinical development]. Acta Clin Belg. 1996;51(1):19-27. French.
- Background Martin-Casabona N, Bahrmand AR, Bennedsen J, Thomsen VO, Curcio M, Fauville-Dufaux M, Feldman K, Havelkova M, Katila ML, Koksalan K, Pereira MF, Rodrigues F, Pfyffer GE, Portaels F, Urgell JR, Rusch-Gerdes S, Tortoli E, Vincent V, Watt B; Spanish Group for Non-Tuberculosis Mycobacteria. Non-tuberculous mycobacteria: patterns of isolation. A multi-country retrospective survey. Int J Tuberc Lung Dis. 2004 Oct;8(10):1186-93.
- Background Yates MD, Pozniak A, Uttley AH, Clarke R, Grange JM. Isolation of environmental mycobacteria from clinical specimens in south-east England: 1973-1993. Int J Tuberc Lung Dis. 1997 Feb;1(1):75-80.
- Background Andrejak C, Lescure FX, Douadi Y, Laurans G, Smail A, Duhaut P, Jounieaux V, Schmit JL. Non-tuberculous mycobacteria pulmonary infection: management and follow-up of 31 infected patients. J Infect. 2007 Jul;55(1):34-40. doi: 10.1016/j.jinf.2007.01.008. Epub 2007 Mar 13.
- Background Andrejak C, Lescure FX, Pukenyte E, Douadi Y, Yazdanpanah Y, Laurans G, Schmit JL, Jounieaux V; Xenopi Group. Mycobacterium xenopi pulmonary infections: a multicentric retrospective study of 136 cases in north-east France. Thorax. 2009 Apr;64(4):291-6. doi: 10.1136/thx.2008.096842. Epub 2008 Dec 3.
- Background Costrini AM, Mahler DA, Gross WM, Hawkins JE, Yesner R, D'Esopo ND. Clinical and roentgenographic features of nosocomial pulmonary disease due to Mycobacterium xenopi. Am Rev Respir Dis. 1981 Jan;123(1):104-9. doi: 10.1164/arrd.1981.123.1.104.
- Background Andrejak C, Thomsen VO, Johansen IS, Riis A, Benfield TL, Duhaut P, Sorensen HT, Lescure FX, Thomsen RW. Nontuberculous pulmonary mycobacteriosis in Denmark: incidence and prognostic factors. Am J Respir Crit Care Med. 2010 Mar 1;181(5):514-21. doi: 10.1164/rccm.200905-0778OC. Epub 2009 Dec 10.
- Background Dautzenberg B, Papillon F, Lepitre M, Truffot-Pernod C, Chauvin JP. Mycobacterium xenopi infections treated with clarithromycine-containing regimens. Annual meeting, 33rd Interscience Conference on Antimicrobial Agents and Chemotherapy.
- Background Alfandari S. Recommandations du C-CLIN Paris Nord pour le diagnostic et le traitement des infections ostéo-articulaires à Mycobacterium xenopi. Med Mal Infect 28 :231-234, 1998.
- Background Klemens SP, Cynamon MH. Activities of azithromycin and clarithromycin against nontuberculous mycobacteria in beige mice. Antimicrob Agents Chemother. 1994 Jul;38(7):1455-9. doi: 10.1128/AAC.38.7.1455.
- Background Lounis N, Truffot-Pernot C, Bentoucha A, Robert J, Ji B, Grosset J. Efficacies of clarithromycin regimens against Mycobacterium xenopi in mice. Antimicrob Agents Chemother. 2001 Nov;45(11):3229-30. doi: 10.1128/AAC.45.11.3229-3230.2001.
- Background Jenkins PA, Campbell IA, Banks J, Gelder CM, Prescott RJ, Smith AP. Clarithromycin vs ciprofloxacin as adjuncts to rifampicin and ethambutol in treating opportunist mycobacterial lung diseases and an assessment of Mycobacterium vaccae immunotherapy. Thorax. 2008 Jul;63(7):627-34. doi: 10.1136/thx.2007.087999. Epub 2008 Feb 4.
- Background Varadi RG, Marras TK. Pulmonary Mycobacterium xenopi infection in non-HIV-infected patients: a systematic review. Int J Tuberc Lung Dis. 2009 Oct;13(10):1210-8.
- Background Wallace RJ Jr, Brown BA, Griffith DE, Girard WM, Murphy DT. Clarithromycin regimens for pulmonary Mycobacterium avium complex. The first 50 patients. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1766-72. doi: 10.1164/ajrccm.153.6.8665032.
- Background Dautzenberg B, Piperno D, Diot P, Truffot-Pernot C, Chauvin JP. Clarithromycin in the treatment of Mycobacterium avium lung infections in patients without AIDS. Clarithromycin Study Group of France. Chest. 1995 Apr;107(4):1035-40. doi: 10.1378/chest.107.4.1035.
- Background Griffith DE, Brown BA, Cegielski P, Murphy DT, Wallace RJ Jr. Early results (at 6 months) with intermittent clarithromycin-including regimens for lung disease due to Mycobacterium avium complex. Clin Infect Dis. 2000 Feb;30(2):288-92. doi: 10.1086/313644.
- Background Griffith DE, Brown BA, Girard WM, Murphy DT, Wallace RJ Jr. Azithromycin activity against Mycobacterium avium complex lung disease in patients who were not infected with human immunodeficiency virus. Clin Infect Dis. 1996 Nov;23(5):983-9. doi: 10.1093/clinids/23.5.983.
- Background Tanaka E, Kimoto T, Tsuyuguchi K, Watanabe I, Matsumoto H, Niimi A, Suzuki K, Murayama T, Amitani R, Kuze F. Effect of clarithromycin regimen for Mycobacterium avium complex pulmonary disease. Am J Respir Crit Care Med. 1999 Sep;160(3):866-72. doi: 10.1164/ajrccm.160.3.9811086.
- Background Dauendorffer JN, Laurain C, Weber M, Dailloux M. In vitro sensitivity of Mycobacterium xenopi to five antibiotics. Pathol Biol (Paris). 2002 Dec;50(10):591-4. doi: 10.1016/s0369-8114(02)00360-7.
- Background Berlin OG, Young LS, Floyd-Reising SA, Bruckner DA. Comparative in vitro activity of the new macrolide A-56268 against mycobacteria. Eur J Clin Microbiol. 1987 Aug;6(4):486-7. doi: 10.1007/BF02013117. No abstract available.
- Background Fraschini F, Scaglione F, Pintucci G, Maccarinelli G, Dugnani S, Demartini G. The diffusion of clarithromycin and roxithromycin into nasal mucosa, tonsil and lung in humans. J Antimicrob Chemother. 1991 Feb;27 Suppl A:61-5. doi: 10.1093/jac/27.suppl_a.61.
- Background Wallace RJ Jr, Brown BA, Griffith DE. Drug intolerance to high-dose clarithromycin among elderly patients. Diagn Microbiol Infect Dis. 1993 Mar-Apr;16(3):215-21. doi: 10.1016/0732-8893(93)90112-k.
- Background Gillespie SH, Billington O. Activity of moxifloxacin against mycobacteria. J Antimicrob Chemother. 1999 Sep;44(3):393-5. doi: 10.1093/jac/44.3.393.
- Background Alcaide F, Calatayud L, Santin M, Martin R. Comparative in vitro activities of linezolid, telithromycin, clarithromycin, levofloxacin, moxifloxacin, and four conventional antimycobacterial drugs against Mycobacterium kansasii. Antimicrob Agents Chemother. 2004 Dec;48(12):4562-5. doi: 10.1128/AAC.48.12.4562-4565.2004.
- Background Rodriguez Diaz JC, Lopez M, Ruiz M, Royo G. In vitro activity of new fluoroquinolones and linezolid against non-tuberculous mycobacteria. Int J Antimicrob Agents. 2003 Jun;21(6):585-8. doi: 10.1016/s0924-8579(03)00048-7.
- Background Gosling RD, Uiso LO, Sam NE, Bongard E, Kanduma EG, Nyindo M, Morris RW, Gillespie SH. The bactericidal activity of moxifloxacin in patients with pulmonary tuberculosis. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1342-5. doi: 10.1164/rccm.200305-682OC. Epub 2003 Aug 13.
- Background Bermudez LE, Kolonoski P, Petrofsky M, Wu M, Inderlied CB, Young LS. Mefloquine, moxifloxacin, and ethambutol are a triple-drug alternative to macrolide-containing regimens for treatment of Mycobacterium avium disease. J Infect Dis. 2003 Jun 15;187(12):1977-80. doi: 10.1086/375352. Epub 2003 Jun 4.
- Background Bermudez LE, Inderlied CB, Kolonoski P, Petrofsky M, Aralar P, Wu M, Young LS. Activity of moxifloxacin by itself and in combination with ethambutol, rifabutin, and azithromycin in vitro and in vivo against Mycobacterium avium. Antimicrob Agents Chemother. 2001 Jan;45(1):217-22. doi: 10.1128/AAC.45.1.217-222.2001.
- Background Veziris N, Truffot-Pernot C, Aubry A, Jarlier V, Lounis N. Fluoroquinolone-containing third-line regimen against Mycobacterium tuberculosis in vivo. Antimicrob Agents Chemother. 2003 Oct;47(10):3117-22. doi: 10.1128/AAC.47.10.3117-3122.2003.
- Background Valerio G, Bracciale P, Manisco V, Quitadamo M, Legari G, Bellanova S. Long-term tolerance and effectiveness of moxifloxacin therapy for tuberculosis: preliminary results. J Chemother. 2003 Feb;15(1):66-70. doi: 10.1179/joc.2003.15.1.66.
- Background Moadebi S, Harder CK, Fitzgerald MJ, Elwood KR, Marra F. Fluoroquinolones for the treatment of pulmonary tuberculosis. Drugs. 2007;67(14):2077-99. doi: 10.2165/00003495-200767140-00007.
- Background Shandil RK, Jayaram R, Kaur P, Gaonkar S, Suresh BL, Mahesh BN, Jayashree R, Nandi V, Bharath S, Balasubramanian V. Moxifloxacin, ofloxacin, sparfloxacin, and ciprofloxacin against Mycobacterium tuberculosis: evaluation of in vitro and pharmacodynamic indices that best predict in vivo efficacy. Antimicrob Agents Chemother. 2007 Feb;51(2):576-82. doi: 10.1128/AAC.00414-06. Epub 2006 Dec 4.
- Background Teeter JG, Bleecker ER. Relationship between airway obstruction and respiratory symptoms in adult asthmatics. Chest. 1998 Feb;113(2):272-7. doi: 10.1378/chest.113.2.272.
- Background Begaud B, Evreux JC, Jouglard J, Lagier G. [Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France]. Therapie. 1985 Mar-Apr;40(2):111-8. No abstract available. French.
- Background Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clarithromycin | Small molecule | 500 mg | — |
| Subject | Moxifloxacin | Small molecule | 400 mg | — |