Treatment of Mycobacterium Xenopi Pulmonary Infection (CAMOMY)

This study is currently recruiting participants.

Verified February 2012 by Centre Hospitalier Universitaire, Amiens

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

History of Changes

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:

MedlinePlus related topics: Mycobacterial Infections Tuberculosis

Drug Information available for: Clarithromycin Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

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

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 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
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
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

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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, Atypical
Tuberculosis
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Clarithromycin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Protein Synthesis Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013

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