Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
92 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-03-02
Study Completion Date
2019-03-31
Brief Summary
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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.
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Detailed Description
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In France, Mycobacterium xenopi is the second non-tuberculous mycobacteria responsible of pulmonary infections. There are few data in the literature regarding its treatment apart from two small randomized trials (42 and 34 patients, respectively) and a French retrospective study (136 patients). So, we decided to conduct a prospective randomized multicenter study to evaluate two treatment regimens for Mycobacterium xenopi pulmonary infection in 6-months sputum conversion.
Main objective: To determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with M.xenopi pulmonary infections according to ATS / IDSA 2007 criteria.
Secondary Objectives: To compare the rate of sputum conversion after 3 and 6 months of treatment the clinical and radiological outcome and the 12 months mortality.
primary endpoint : Result of culture of respiratory samples 6 months after starting treatment.Culture samples taken 6 months after starting treatment against M. xenopi is either positive (presence of M. xenopi colonies with or without smear positive) or negative with smear and culture negative (see data collection and measurement methods).
Study plan: Any patient with at least one positive pulmonary M. xenopi sample may be eligible. If the patient underwent ATS / IDSA 2007 criteria of M. xenopi pulmonary infection (after clinical , radiological and microbiological evaluation), in the absence of exclusion criteria, the patient will be randomized to one of the two treatment arms (rifampicin+ ethambutol + clarithromycin or rifampicin + ethambutol + moxifloxacin). A clinical, radiological, microbiological and pharmacological monitoring will be done for each randomized patient. The recommended treatment duration is 12 months after conversion with a maximum duration of 18 months.
Number of patients required: This is a prospective randomized study with 2 parallel groups. The primary endpoint is considered for the whole study population. For an α risk of 5%, an accuracy of 10%, an expected conversion rate of 70% a total of 80 patients is required . For a 15% rate of non evaluable patients (died, lost of follow-up) we need to include 92 patients.
Study Duration: Inclusion for 24 months with a minimum follow-up of 6 months (to meet the main objective), and if possible a follow-up of 12 months per patient to meet the overall objectives of the study.
Prospects: To establish new treatment recommendations for M.xenopi pulmonary infection, based on microbiological and clinical efficacy criteria and tolerance criteria.
Main objective: To determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with M.xenopi pulmonary infections according to ATS / IDSA 2007 criteria.
Secondary Objectives: To compare the rate of sputum conversion after 3 and 6 months of treatment the clinical and radiological outcome and the 12 months mortality.
primary endpoint : Result of culture of respiratory samples 6 months after starting treatment.Culture samples taken 6 months after starting treatment against M. xenopi is either positive (presence of M. xenopi colonies with or without smear positive) or negative with smear and culture negative (see data collection and measurement methods).
Study plan: Any patient with at least one positive pulmonary M. xenopi sample may be eligible. If the patient underwent ATS / IDSA 2007 criteria of M. xenopi pulmonary infection (after clinical , radiological and microbiological evaluation), in the absence of exclusion criteria, the patient will be randomized to one of the two treatment arms (rifampicin+ ethambutol + clarithromycin or rifampicin + ethambutol + moxifloxacin). A clinical, radiological, microbiological and pharmacological monitoring will be done for each randomized patient. The recommended treatment duration is 12 months after conversion with a maximum duration of 18 months.
Number of patients required: This is a prospective randomized study with 2 parallel groups. The primary endpoint is considered for the whole study population. For an α risk of 5%, an accuracy of 10%, an expected conversion rate of 70% a total of 80 patients is required . For a 15% rate of non evaluable patients (died, lost of follow-up) we need to include 92 patients.
Study Duration: Inclusion for 24 months with a minimum follow-up of 6 months (to meet the main objective), and if possible a follow-up of 12 months per patient to meet the overall objectives of the study.
Prospects: To establish new treatment recommendations for M.xenopi pulmonary infection, based on microbiological and clinical efficacy criteria and tolerance criteria.
Conditions
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Atypical; Mycobacterium, Pulmonary, Tuberculous
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Clarithromycin
Group Type
EXPERIMENTAL
Clarithromycin
Intervention Type
DRUG
500 mg twice a day seven days a week
Moxifloxacin
Group Type
EXPERIMENTAL
Moxifloxacin
Intervention Type
DRUG
400 mg per day seven days a week
Interventions
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Clarithromycin
500 mg twice a day seven days a week
Intervention Type
DRUG
Moxifloxacin
400 mg per day seven days a week
Intervention Type
DRUG
Other Intervention Names
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ZECLAR, NAXY
IZILOX
Eligibility Criteria
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Inclusion Criteria
* The patient and/or legal representative of the patient has provided a written informed consent before inclusion in the study
* The patient is aged 18 or older
* The patient has signs of functional respiratory (cough, sputum, hemoptysis, dyspnea, chest pain and / or general signs (asthenia and / or anorexia and / or weight loss)
* The patient has a creatinine clearance above 30 ml / min
* The patient underwent a thoracic scan not older than one month before the first positive bacteriological sample.
* The patient underwent a bronchoscopy with sampling conducted in the territory corresponding to the radiographic
* The most plausible alternative diagnostics have been eliminated using the thoracic scan and bronchoscopy
* The patient has at least two positive cultures for M. xenopi sputum collected on two separate days AND/OR a positive culture for M. xenopi in a bronchoalveolar lavage or bronchial aspiration directed AND / OR transbronchial biopsy or lung biopsy with surgical histology for a mycobacterial infection (granuloma or Ziehl positive) and a culture positive M. xenopi, AND / OR biopsy with histology compatible with mycobacteriosis and one or more positive sputum culture for M . xenopi
* The patient is willing and able to take the study treatment throughout the duration
* If this is a woman of childbearing age, the patient is ready to use for the duration of the test contraception method other than estrogen-progestin
* The patient did not participate in another study evaluating an investigational drug within 30 days prior to enrollment in the study and agrees not to participate in another study for the duration of the study
* The patient is informed by the doctor and agreed that its data are processed in this study
* The patient understands / reads French and has no difficulty understanding the objectives of the study
* The patient has health insurance coverage
* The patient is aged 18 or older
* The patient has signs of functional respiratory (cough, sputum, hemoptysis, dyspnea, chest pain and / or general signs (asthenia and / or anorexia and / or weight loss)
* The patient has a creatinine clearance above 30 ml / min
* The patient underwent a thoracic scan not older than one month before the first positive bacteriological sample.
* The patient underwent a bronchoscopy with sampling conducted in the territory corresponding to the radiographic
* The most plausible alternative diagnostics have been eliminated using the thoracic scan and bronchoscopy
* The patient has at least two positive cultures for M. xenopi sputum collected on two separate days AND/OR a positive culture for M. xenopi in a bronchoalveolar lavage or bronchial aspiration directed AND / OR transbronchial biopsy or lung biopsy with surgical histology for a mycobacterial infection (granuloma or Ziehl positive) and a culture positive M. xenopi, AND / OR biopsy with histology compatible with mycobacteriosis and one or more positive sputum culture for M . xenopi
* The patient is willing and able to take the study treatment throughout the duration
* If this is a woman of childbearing age, the patient is ready to use for the duration of the test contraception method other than estrogen-progestin
* The patient did not participate in another study evaluating an investigational drug within 30 days prior to enrollment in the study and agrees not to participate in another study for the duration of the study
* The patient is informed by the doctor and agreed that its data are processed in this study
* The patient understands / reads French and has no difficulty understanding the objectives of the study
* The patient has health insurance coverage
Exclusion Criteria
* Hypersensitivity to any of the molecules (rifampicin, ethambutol, moxifloxacin, clarithromycin)
* Any patient with a relapse of a lung infection with M. xenopi
* The patient is treated with molecules that can interfere with cytochrome P450 and can not be replaced by another therapeutic class
* The patient is treated by prolonging the QT molecules which can not be replaced by another therapeutic class
* The patient is treated with alkaloid of ergot, cisapride, biperidil, pimozide, mizolastine
* The patient has heart failure with left ventricular ejection fraction below 30%
* Discovered on the balance sheet or history, we find that the patient infection with human immunodeficiency virus HIV 1 and 2 a long QT on ECG and / or arrhythmias or clinically significant bradycardia judged by the investigator cytolysis with transaminases increase more than 5 times normal renal failure with creatinine clearance below 30 ml / min
* The patient has cirrhosis Child Pugh C and / or porphyria
* There pregnancy or during breastfeeding
* The patient has an inability to meet the protocol requirements, including active substance abuse, according to the investigator.
* The patient has a history of tendinopathy with a fluoroquinolone
* The patient has a congenital galactosemia, malabsorption of glucose and galactose, or lactase deficiency
* The patient has a NORB (abnormalities of the visual field or color vision tested by an eye examination prior)
* Any other situation that, in the opinion of the investigator, would imply that participation in the study is not in the interest of the patient
* There is a risk of difficulty of monitoring, such as imminent transfer to a different region or country
* Any patient with a relapse of a lung infection with M. xenopi
* The patient is treated with molecules that can interfere with cytochrome P450 and can not be replaced by another therapeutic class
* The patient is treated by prolonging the QT molecules which can not be replaced by another therapeutic class
* The patient is treated with alkaloid of ergot, cisapride, biperidil, pimozide, mizolastine
* The patient has heart failure with left ventricular ejection fraction below 30%
* Discovered on the balance sheet or history, we find that the patient infection with human immunodeficiency virus HIV 1 and 2 a long QT on ECG and / or arrhythmias or clinically significant bradycardia judged by the investigator cytolysis with transaminases increase more than 5 times normal renal failure with creatinine clearance below 30 ml / min
* The patient has cirrhosis Child Pugh C and / or porphyria
* There pregnancy or during breastfeeding
* The patient has an inability to meet the protocol requirements, including active substance abuse, according to the investigator.
* The patient has a history of tendinopathy with a fluoroquinolone
* The patient has a congenital galactosemia, malabsorption of glucose and galactose, or lactase deficiency
* The patient has a NORB (abnormalities of the visual field or color vision tested by an eye examination prior)
* Any other situation that, in the opinion of the investigator, would imply that participation in the study is not in the interest of the patient
* There is a risk of difficulty of monitoring, such as imminent transfer to a different region or country
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Centre Hospitalier Universitaire, Amiens
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Claire ANDREJAK, Dr
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire, Amiens
Claire ANDREJAK, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Amiens
Vincent JOUNIEAUX, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU Amiens
Nicolas VEZIRIS, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
APHP Pitie Salpetriere Hospital, National Center Of Mycobacteria
Jacques CADRANEL, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Tenon Hospital APHP Paris
Francois-Xavier LESCURE, MD
Role: PRINCIPAL_INVESTIGATOR
Tenon hospital APHP Paris
Locations
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CH Compiègne
Compiègne, Compiègne, France
Site Status
CH Intercommunal Meulan
Les Mureaux, Les Mureaux, France
Site Status
Centre National de Reference Des Mycobactéries
Paris, PARIS, France
Site Status
CH Saint-Nazaire
Saint-Nazaire, Saint-Nazaire, France
Site Status
CH Troyes
Troyes, Troyes, France
Site Status
CH Abbeville
Abbeville, , France
Site Status
CHU Amiens
Amiens, , France
Site Status
CHU Angers
Angers, , France
Site Status
CH Argenteuil
Argenteuil, , France
Site Status
CHU Besançon
Besançon, , France
Site Status
CH Béthune
Béthune, , France
Site Status
Assistance Publique Hôpitaux de Paris CHU Avicenne
Bobigny, , France
Site Status
CHU Brest La Cavale
Brest, , France
Site Status
CHU Caen
Caen, , France
Site Status
CH Cannes
Cannes, , France
Site Status
CHU Clermont Ferrand Hôpital Gabriel Mont pied
Clermont-Ferrand, , France
Site Status
CH Sud Francilien
Corbeil-Essonnes, , France
Site Status
Centre Intercommunal de Créteil
Créteil, , France
Site Status
CHU Dijon
Dijon, , France
Site Status
CH Gonesse
Gonesse, , France
Site Status
CHU Grenoble
Grenoble, , France
Site Status
Assistance Publique Hôpitaux de Paris Hôpital Bicetre
Le Kremlin-Bicêtre, , France
Site Status
CH Le MANS
Le Mans, , France
Site Status
CHU Lille Hôpital Calmette
Lille, , France
Site Status
CHU Limoges Hôpital de Cluzeau
Limoges, , France
Site Status
CHU Lyon Hôpital La Croix Rousse
Lyon, , France
Site Status
Hopital Saint-Joseph
Marseille, , France
Site Status
Assistance Publique Hôpitaux de Marseille
Marseille, , France
Site Status
CHU Montpellier Hôpital Arnaud de Villeneuve
Montpellier, , France
Site Status
CHU Nantes
Nantes, , France
Site Status
CHU Nice
Nice, , France
Site Status
Chr Orleans
Orléans, , France
Site Status
Assistance Publique Hôpitaux de Paris Hôpital Saint Louis
Paris, , France
Site Status
Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine
Paris, , France
Site Status
Assistance Publique Hôpitaux de Paris Hôpital BICHAT
Paris, , France
Site Status
Assistance Publique Hôpitaux de Paris, hôpital TENON
Paris, , France
Site Status
CHU Bordeaux Hôpital Haut Leveque
Pessac, , France
Site Status
CHU Poitiers
Poitiers, , France
Site Status
Hopital René DUBOS
Pontoise, , France
Site Status
CHU Reims
Reims, , France
Site Status
CHU de Rennes Hôpital Ponchaillou
Rennes, , France
Site Status
CH de Roubaix
Roubaix, , France
Site Status
CHU Rouen
Rouen, , France
Site Status
CHU de Saint Etienne
Saint-Etienne, , France
Site Status
CH de Saint Quentin
Saint-Quentin, , France
Site Status
CHU de Strasbourg
Strasbourg, , France
Site Status
Hôpital FOCH
Suresnes, , France
Site Status
CHU Toulouse
Toulouse, , France
Site Status
CH de Tourcoing
Tourcoing, , France
Site Status
CHU Tours Hôpital BRETONNEAU
Tours, , France
Site Status
CH de Valenciennes
Valenciennes, , France
Site Status
CHU Nancy
Vandœuvre-lès-Nancy, , France
Site Status
Countries
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France
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
American Thoracic Society. Diagnosis standards and classification of tuberculosis and other mycobacterial diseases. New York: American Lung Association, 1974:25
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PHRCN10-DR-ANDREJAK-MELLE
Identifier Type: -
Identifier Source: org_study_id
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