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Treatment of Mycobacterium Xenopi Pulmonary Infection (CAMOMY)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01298336
First received: February 15, 2011
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Atypical; Mycobacterium, Pulmonary, Tuberculous
Drug: Clarithromycin
Drug: Moxifloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Sputum conversion at 6 months under three antibiotics treatment (Rifampin, ethambutol and a third drug clarithromycin or moxifloxacin) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Results of the smear and culture of three respiratory samples after 6 months of treatment.


Secondary Outcome Measures:
  • Sputum conversion at 3, 6, 9 and 12 months of treatment in the two different arms (clarithromycin containing regimen versus moxifloxacin containing regimen [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At each endpoint (3, 6, 9 and 12 months), respiratory sample will be analyzed (smear and culture) to answer the second objective (to compare microbiological efficacy of clarithromycin-containing regimen versus moxifloxacin-containing regimen)

  • Clinical and radiological outcome after 3, 6 and 12 months of treatment according to the treatment arm [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    At each end-point (3, 6 and 12 months) :

    • clinical evaluation with analogic scale (sputum, cough, dyspnea, chest pain, hemoptysis) and weight
    • radiological evaluation: comparison of the size and number of lesions at each endpoint with basal data

  • Mortality after 12 months of treatment in the two compared regimen [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mortality status will be evaluated after 12 months of treatment. In case of deaths under treatment, the date will be collected. Comparative survival analysis will be realized between the two arms of treatment

  • Gastrointestinal toxicity and hematotoxicity after 1- 3- 6- 9- 12- months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    At each end point (1- 3- 6- 9- 12 months), Rhodes score (gastro-intestinal tolerance)and WHO score for hematological, and gastrointestinal toxicity will be collected in the two arms


Estimated Enrollment: 92
Study Start Date: February 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clarithromycin Drug: Clarithromycin
500 mg twice a day seven days a week
Other Name: ZECLAR, NAXY
Experimental: Moxifloxacin Drug: Moxifloxacin
400 mg per day seven days a week
Other Name: IZILOX

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298336

Contacts
Contact: Claire ANDREJAK, Dr +33 3 22 45 59 05 clandrejak@gmail.com
Contact: Sophie Liabeuf, Pr +33 3 22 45 60 85 liabeuf.sophie@chu-amiens.fr

Locations
France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Claire ANDREJAK, MD    +33322455907    clandrejak@gmail.com   
Contact: Vincent JOUNIEAUX, MD    +33322455905    jounieaux.vincent@chu-amiens.fr   
Principal Investigator: Claire ANDREJAK, MD         
Sub-Investigator: Vincent JOUNIEAUX, MD PhD         
Sub-Investigator: Jean-Luc SCHMIT, MD PhD         
CHU Angers Not yet recruiting
Angers, France, 49033
Contact: Pascaline PRIOU, MD    +332 41 35 36 95    pascaline.priou@wanadoo.fr   
Principal Investigator: Pascaline PRIOU, MD         
CH Argenteuil Not yet recruiting
Argenteuil, France, 95100
Contact: Hubert DE CREMOUX, MD    +331 34 23 14 74    hubert.decremoux@ch-argenteuil.fr   
Contact: Juliette CAMUSET, MD    +331 34 23 14 74    juliette.camuset@ch-argenteuil.fr   
Sub-Investigator: Laurence Courdavault, MD         
Principal Investigator: Hubert De Cremoux, MD         
Sub-Investigator: Juliette Camuset, MD         
CHU Besançon Not yet recruiting
Besançon, France, 25030
Contact: Jean-Charles DALPHIN, MD PhD    +33 3.81.66.88.02      
Principal Investigator: Jean-Charles DALPHIN, MD-PhD         
Assistance Publique Hôpitaux de Paris CHU Avicenne Recruiting
Bobigny, France, 93009
Contact: Dominique VALEYRE, MD PhD    +33 1 48 95 51 21    dominique.valeyre@avc.aphp.fr   
Principal Investigator: Dominique VALEYRE, MD PhD         
CHU Brest La Cavale Recruiting
Brest, France, 29609
Contact: Francis COUTURAUD, MD PhD    +332 98 34 73 50    francis.couturaud@chu-brest.fr   
Principal Investigator: Francis COUTURAUD, 29609         
CH Béthune Recruiting
Béthune, France, 62408
Contact: Frederic BART, MD    +333 21 64 43 35    fbart@ch-bethune.fr   
Principal Investigator: Frederic BART, MD         
CHU Caen Not yet recruiting
Caen, France, 14033
Contact: Gérard ZALCMAN, MD-PhD    +332 31 06 46 77    zalcman-g@chu-caen.fr   
Principal Investigator: Gérard ZALCMAN, MD PhD         
CH Cannes Not yet recruiting
Cannes, France, 06401
Contact: Christophe PERRIN, MD    +334 93 69 71 10    c.perrin@ch-cannes.fr   
Principal Investigator: Christophe PERRIN, MD         
CHU Clermont Ferrand Hôpital Gabriel Mont pied Not yet recruiting
Clermont Ferrand, France, 63000
Contact: Olivier LESENS, MD PhD    +33 4 73 75 26 59    olesens@chu-clermontferrand.fr   
Principal Investigator: Olivier LESENS, MD PhD         
Centre Intercommunal de Créteil Not yet recruiting
Creteil, France, 94010
Contact: Bruno HOUSSET, MD PhD    +33 1 57 02 20 70    bruno.housset@chicreteil.fr   
Principal Investigator: Bruno HOUSSET, MD PhD         
CHU Dijon Not yet recruiting
Dijon, France, 21079
Contact: François MASSIN, MD    +333 80 29 32 49    francois.massin@chu-dijon.fr   
Principal Investigator: François MASSIN, MD         
CH Gonesse Not yet recruiting
Gonesse, France, 95503
Contact: Florence GERBER, MD    +331 34 53 20 14    florencegerber@ch-gonesse.fr   
Principal Investigator: Florence GERBER, MD         
CHU Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Christophe PISON, MD-PhD    +33 4 76 76 54 79    CPison@chu-grenoble.fr   
Principal Investigator: Christophe PISON, MD PhD         
Sub-Investigator: Max MAURIN, MD-PhD         
Assistance Publique Hôpitaux de Paris Hôpital Bicetre Not yet recruiting
Kremlin Bicetre, France, 94275
Contact: François Xavier BLANC, MD PhD    +33 1 45 21 25 33    xavier.blanc@bct.aphp.fr   
Principal Investigator: François Xavier BLANC, MD PhD         
CH Le MANS Not yet recruiting
Le Mans, France, 72037
Contact: Francois GOUPIL, MD    +33 2 43 43 43 52    fgoupil@ch-lemans.fr   
Principal Investigator: François Goupil, MD         
CHU Lille Hôpital Calmette Not yet recruiting
Lille, France, 59037
Contact: Jean- Francois BERVAR, MD    +33 3 20 44 43 18    j-bervar@chru-lille.fr   
Principal Investigator: Jean François BERVAR, MD         
Sub-Investigator: Benoit GUERY, MD PhD         
CHU Limoges Hôpital de Cluzeau Not yet recruiting
Limoges, France, 87042
Contact: Boris MELLONI, MD-PhD    +33 5 55 05 68 81    boris.melloni@unilim.fr   
Principal Investigator: Boris MELLONI, MD PhD         
CHU Lyon Hôpital La Croix Rousse Not yet recruiting
Lyon, France, 69004
Contact: Pascale NESME, MD    +33 4 72 07 17 32    pascale.nesme-meyer@chu-lyon.fr   
Principal Investigator: Pascale NESME, MD         
Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13009
Contact: Pascal CHANEZ, MD PhD    +33 4 91 74 46 30    pascal.chanez@univmed.fr   
Principal Investigator: Pascal CHANEZ, MD-PhD         
CHU Montpellier Hôpital Arnaud de Villeneuve Not yet recruiting
Montpellier, France, 34295
Contact: Arnaud BOURDIN, MD    +33 4 67 33 61 18    a-bourdin@chu-montpellier.fr   
Principal Investigator: Arnaud BOURDIN, MD         
Sub-Investigator: Jean-Pierre MALLET, MD         
CHU Nantes Not yet recruiting
Nantes, France, 44000
Contact: David BOUTOILLE, MD    +33 2 40 47 66 18    david.boutoille@chu-nantes.fr   
Principal Investigator: David Boutoille, MD         
CHU Nice Not yet recruiting
Nice, France, 06002
Contact: Charles Hugo MARQUETTE, MD-PhD    +33 4 92 03 88 83    marquette.ch@chu-nice.fr   
Principal Investigator: Charles-Hugo MARQUETTE, MD PhD         
Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine Not yet recruiting
Paris, France, 75012
Contact: Christos CHOUAID, MD PhD    +33 1 49 28 25 16    christos.chouaid@sat.ap-hop-paris.fr   
Principal Investigator: Christos CHOUAID, MD PhD         
Assistance Publique Hôpitaux de Paris Hôpital Saint Louis Not yet recruiting
Paris, France, 75010
Contact: Anne Bergeron-Lafaurie, MD PhD    +33 1 42 49 41 65    anne.bergeron-lafaurie@sls.aphp.fr   
Principal Investigator: Anne Bergeron-Lafaurie, MD PhD         
Assistance Publique Hôpitaux de Paris, hôpital TENON Not yet recruiting
Paris, France, 75020
Contact: Jacques CADRANEL, MD PhD    +331 56 01 61 47    jacques.cadranel@tnn.aphp.fr   
Principal Investigator: Jacques CADRANEL, MD PhD         
Sub-Investigator: François Xavier LESCURE, MD         
Centre National de Reference Des Mycobactéries Active, not recruiting
Paris, France, 75013
Assistance Publique Hôpitaux de Paris Hôpital BICHAT Not yet recruiting
Paris, France, 75018
Contact: Bruno CRESTANI, MD PhD    +33 1 40 25 68 00    bruno.crestani@bch.aphp.fr   
Principal Investigator: Bruno Crestani, MD PhD         
Sub-Investigator: Gabriel Thabut, MD PhD         
Sub-Investigator: Hervé Mal, MD PhD         
CHU Bordeaux Hôpital Haut Leveque Not yet recruiting
Pessac, France, 33604
Contact: Carine GREIB, MD    +335 57 65 64 83    carine.greib@chu-bordeaux.fr   
CHU Poitiers Not yet recruiting
Poitiers, France, 86000
Contact: Cendrine GODET, MD    +335 49 44 44 22    c.godet@chu-poitiers.fr   
Principal Investigator: Cendrine GODET, MD         
CHU Reims Recruiting
Reims, France, 51100
Contact: Gaëtan Deslee, MD PhD    +333 26 78 76 09    gdeslee@chu-reims.fr   
Principal Investigator: Gaëtan Deslee, MD PhD         
Sub-Investigator: Christophe STRADY, MD PhD         
CHU de Rennes Hôpital Ponchaillou Not yet recruiting
Rennes, France, 35033
Contact: Stéphane JOUNEAU, MD    +332 99 28 24 78    stephane.jouneau@chu-rennes.fr   
Principal Investigator: Stéphane JOUNEAU, MD         
Sub-Investigator: Pierre Tattevin, MD         
CH de Roubaix Not yet recruiting
Roubaix, France, 59056
Contact: François STEENHOUVER    +333 20 99 31 31    francois.steenhouwer@ch-roubaix.fr   
Principal Investigator: François Steenhouver, MD         
CHU Rouen Not yet recruiting
Rouen, France, 76031
Contact: Jean François MUIR, MD PhD    +332 32 88 90 83    jean-francois.muir@chu-rouen.fr   
Principal Investigator: Jean-François MUIR, MD PhD         
Sub-Investigator: Luc THIBERVILLE, MD PhD         
CHU de Saint Etienne Not yet recruiting
Saint Etienne, France, 42055
Contact: Sofiane Benhadji, MD    +334 77 82 83 14      
Principal Investigator: Sofiane Benhadji, MD         
CH de Saint Quentin Not yet recruiting
Saint Quentin, France, 02100
Contact: Youcef DOUADI, MD    +333.23067536    ydouadi@bbox.fr   
Principal Investigator: Youcef Douadi, MD         
CHU de Strasbourg Not yet recruiting
Strasbourg, France, 67091
Contact: Philippe FRAISSE, MD    +333 69 55 02 09    philippe.fraisse@chru-strasbourg.fr   
Principal Investigator: Philippe FRAISSE, MD         
Hôpital FOCH Not yet recruiting
Suresnes, France, 92150
Contact: Emilie Catherinot, MD    +33 1 42 19 26 63    e.catherinot@gmail.com   
Principal Investigator: Emilie Catherinot, MD         
CHU Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Sarah ABBES, MD    +335 67 77 17 75    abbes.s@chu-toulouse.fr   
Principal Investigator: Sarah ABBES, MD         
CH de Tourcoing Not yet recruiting
Tourcoing, France, 59208
Contact: Yazdan Yazdanpanah, MD PhD    +33 3 20 69 46 17    yyazdanpanah@ch-tourcoing.fr   
Principal Investigator: Yazdan Yazdanpanah, MD PhD         
CHU Tours Hôpital BRETONNEAU Not yet recruiting
Tours, France, 37044
Contact: Sylvain MARCHAND ADAM, MD    +33 2 47 47 37 87    s.marchandadam@univ-tours.fr   
Principal Investigator: Sylvain MARCHAND ADAM, MD         
Sub-Investigator: PHILIPPE LANOTTE, MD         
CH de Valenciennes Not yet recruiting
Valenciennes, France, 59300
Contact: Bruno STACH, MD    +33 3 27 32 53 90    bruno.stach@orange.fr   
Principal Investigator: Bruno STACH, MD         
CHU Nancy Not yet recruiting
Vandeuvre Les Nancy, France, 54511
Contact: Francois CHABOT, MD PhD    +333 83 15 40 21    f.chabot@chu-nancy.fr   
Principal Investigator: François CHABOT, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Study Director: Claire ANDREJAK, Dr Centre Hospitalier Universitaire, Amiens
Principal Investigator: Claire ANDREJAK, MD CHU Amiens
Principal Investigator: Vincent JOUNIEAUX, MD PhD CHU Amiens
Principal Investigator: Nicolas VEZIRIS, MD-PhD APHP Pitie Salpetriere Hospital, National Center Of Mycobacteria
Principal Investigator: Jacques CADRANEL, MD PhD Tenon Hospital APHP Paris
Principal Investigator: Francois-Xavier LESCURE, MD Tenon hospital APHP Paris
  More Information

Publications:
Wallace RJ, O'Brien R, Glassroth J, Raleigh J, Dutt A. American Thoracic Society. Diagnosis and treatment of disease caused by non tuberculous mycobacteria. Am Rev Respir Dis 142:940-53, 1990
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.
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.

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01298336     History of Changes
Other Study ID Numbers: PHRCN10-DR-ANDREJAK-MELLE
Study First Received: February 15, 2011
Last Updated: February 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Mycobacterium Xenopi Pulmonary Infection
Clarithromycin
Moxifloxacin

Additional relevant MeSH terms:
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Clarithromycin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014