Treatment of Mycobacterium Xenopi Pulmonary Infection

Condition(s) targeted: Atypical; Mycobacterium, Pulmonary, Tuberculous

Intervention: Clarithromycin (Drug); Moxifloxacin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire, Amiens

Official(s) and/or principal investigator(s):
Claire ANDREJAK, Dr, Study Director, Affiliation: Centre Hospitalier Universitaire, Amiens
Claire ANDREJAK, MD, Principal Investigator, Affiliation: CHU Amiens
Vincent JOUNIEAUX, MD PhD, Principal Investigator, Affiliation: CHU Amiens
Nicolas VEZIRIS, MD-PhD, Principal Investigator, Affiliation: APHP Pitie Salpetriere Hospital, National Center Of Mycobacteria
Jacques CADRANEL, MD PhD, Principal Investigator, Affiliation: Tenon Hospital APHP Paris
Francois-Xavier LESCURE, MD, Principal Investigator, Affiliation: Tenon hospital APHP Paris

Overall contact:
Claire ANDREJAK, Dr, Phone: +33 3 22 45 59 05, Email: clandrejak@gmail.com

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.

Official title: Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Sputum conversion at 6 months under three antibiotics treatment (Rifampin, ethambutol and a third drug clarithromycin or moxifloxacin)

Secondary outcome:

Sputum conversion at 3, 6, 9 and 12 months of treatment in the two different arms (clarithromycin containing regimen versus moxifloxacin containing regimen

Clinical and radiological outcome after 3, 6 and 12 months of treatment according to the treatment arm

Mortality after 12 months of treatment in the two compared regimen

Gastrointestinal toxicity and hematotoxicity after 1- 3- 6- 9- 12- months of treatment

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Claire ANDREJAK, Dr, Phone: +33 3 22 45 59 05, Email: clandrejak@gmail.com

CHU Amiens, Amiens 80054, France; Recruiting
Claire ANDREJAK, MD, Phone: +33322455907, Email: clandrejak@gmail.com
Vincent JOUNIEAUX, MD, Phone: +33322455905, Email: jounieaux.vincent@chu-amiens.fr
Claire ANDREJAK, MD, Principal Investigator
Vincent JOUNIEAUX, MD PhD, Sub-Investigator
Jean-Luc SCHMIT, MD PhD, Sub-Investigator

CHU Angers, Angers 49033, France; Not yet recruiting
Pascaline PRIOU, MD, Phone: +332 41 35 36 95, Email: pascaline.priou@wanadoo.fr
Pascaline PRIOU, MD, Principal Investigator

CH Argenteuil, Argenteuil 95100, France; Recruiting
Hubert DE CREMOUX, MD, Phone: +331 34 23 14 74, Email: hubert.decremoux@ch-argenteuil.fr
Juliette CAMUSET, MD, Phone: +331 34 23 14 74, Email: juliette.camuset@ch-argenteuil.fr
Laurence Courdavault, MD, Sub-Investigator
Hubert De Cremoux, MD, Principal Investigator
Juliette Camuset, MD, Sub-Investigator

CHU Besançon, Besançon 25030, France; Not yet recruiting
Jean-Charles DALPHIN, MD PhD, Phone: +33 3.81.66.88.02
Jean-Charles DALPHIN, MD-PhD, Principal Investigator

Assistance Publique Hôpitaux de Paris CHU Avicenne, Bobigny 93009, France; Recruiting
Dominique VALEYRE, MD PhD, Phone: +33 1 48 95 51 21, Email: dominique.valeyre@avc.aphp.fr
Dominique VALEYRE, MD PhD, Principal Investigator

CHU Brest La Cavale, Brest 29609, France; Recruiting
Francis COUTURAUD, MD PhD, Phone: +332 98 34 73 50, Email: francis.couturaud@chu-brest.fr
Francis COUTURAUD, 29609, Principal Investigator

CH Béthune, Béthune 62408, France; Recruiting
Frederic BART, MD, Phone: +333 21 64 43 35, Email: fbart@ch-bethune.fr
Frederic BART, MD, Principal Investigator

CHU Caen, Caen 14033, France; Not yet recruiting
Gérard ZALCMAN, MD-PhD, Phone: +332 31 06 46 77, Email: zalcman-g@chu-caen.fr
Gérard ZALCMAN, MD PhD, Principal Investigator

CH Cannes, Cannes 06401, France; Not yet recruiting
Christophe PERRIN, MD, Phone: +334 93 69 71 10, Email: c.perrin@ch-cannes.fr
Christophe PERRIN, MD, Principal Investigator

CHU Clermont Ferrand Hôpital Gabriel Mont pied, Clermont Ferrand 63000, France; Not yet recruiting
Olivier LESENS, MD PhD, Phone: +33 4 73 75 26 59, Email: olesens@chu-clermontferrand.fr
Olivier LESENS, MD PhD, Principal Investigator

CH Compiègne, Compiègne 60321, France; Not yet recruiting
Stéphanie DEHETTE, MD PhD, Phone: +00 3 44 23 62 64, Email: s.dehette@ch-compiegne.fr
Stéphanie DEHETTE, MD PhD, Principal Investigator
Sandrine LOUTSKI, MD PhD, Sub-Investigator

Centre Intercommunal de Créteil, Creteil 94010, France; Not yet recruiting
Bruno HOUSSET, MD PhD, Phone: +33 1 57 02 20 70, Email: bruno.housset@chicreteil.fr
Bruno HOUSSET, MD PhD, Principal Investigator

CHU Dijon, Dijon 21079, France; Recruiting
François MASSIN, MD, Phone: +333 80 29 32 49, Email: francois.massin@chu-dijon.fr
François MASSIN, MD, Principal Investigator

CH Gonesse, Gonesse 95503, France; Not yet recruiting
Florence GERBER, MD, Phone: +331 34 53 20 14, Email: florencegerber@ch-gonesse.fr
Florence GERBER, MD, Principal Investigator

CHU Grenoble, Grenoble 38043, France; Not yet recruiting
Christophe PISON, MD-PhD, Phone: +33 4 76 76 54 79, Email: CPison@chu-grenoble.fr
Christophe PISON, MD PhD, Principal Investigator
Max MAURIN, MD-PhD, Sub-Investigator

Assistance Publique Hôpitaux de Paris Hôpital Bicetre, Kremlin Bicetre 94275, France; Recruiting
François Xavier BLANC, MD PhD, Phone: +33 1 45 21 25 33, Email: xavier.blanc@bct.aphp.fr
François Xavier BLANC, MD PhD, Principal Investigator

CH Le MANS, Le Mans 72037, France; Not yet recruiting
Francois GOUPIL, MD, Phone: +33 2 43 43 43 52, Email: fgoupil@ch-lemans.fr
François Goupil, MD, Principal Investigator

CH Intercommunal Meulan, Les Mureaux 78250, France; Not yet recruiting
Etienne LEROY-TERQUEN, MD PhD, Phone: + 33 1 30 22 41 10, Email: etiennelt@hotmail.com
Etienne LEROY-TERQUEN, MD PhD, Principal Investigator
Hassen BELKACEMI, MD PhD, Sub-Investigator

CHU Lille Hôpital Calmette, Lille 59037, France; Recruiting
Jean- Francois BERVAR, MD, Phone: +33 3 20 44 43 18, Email: j-bervar@chru-lille.fr
Jean François BERVAR, MD, Principal Investigator
Benoit GUERY, MD PhD, Sub-Investigator

CHU Limoges Hôpital de Cluzeau, Limoges 87042, France; Recruiting
Boris MELLONI, MD-PhD, Phone: +33 5 55 05 68 81, Email: boris.melloni@unilim.fr
Boris MELLONI, MD PhD, Principal Investigator

CHU Lyon Hôpital La Croix Rousse, Lyon 69004, France; Not yet recruiting
Pascale NESME, MD, Phone: +33 4 72 07 17 32, Email: pascale.nesme-meyer@chu-lyon.fr
Pascale NESME, MD, Principal Investigator

Assistance Publique Hôpitaux de Marseille, Marseille 13009, France; Active, not recruiting

CHU Montpellier Hôpital Arnaud de Villeneuve, Montpellier 34295, France; Not yet recruiting
Arnaud BOURDIN, MD, Phone: +33 4 67 33 61 18, Email: a-bourdin@chu-montpellier.fr
Arnaud BOURDIN, MD, Principal Investigator
Jean-Pierre MALLET, MD, Sub-Investigator

CHU Nantes, Nantes 44000, France; Not yet recruiting
David BOUTOILLE, MD, Phone: +33 2 40 47 66 18, Email: david.boutoille@chu-nantes.fr
David Boutoille, MD, Principal Investigator

CHU Nice, Nice 06002, France; Not yet recruiting
Charles Hugo MARQUETTE, MD-PhD, Phone: +33 4 92 03 88 83, Email: marquette.ch@chu-nice.fr
Charles-Hugo MARQUETTE, MD PhD, Principal Investigator

Assistance Publique Hôpitaux de Paris Hôpital BICHAT, Paris 75018, France; Recruiting
Bruno CRESTANI, MD PhD, Phone: +33 1 40 25 68 00, Email: bruno.crestani@bch.aphp.fr
Bruno Crestani, MD PhD, Principal Investigator
Gabriel Thabut, MD PhD, Sub-Investigator
Hervé Mal, MD PhD, Sub-Investigator

Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine, Paris 75012, France; Not yet recruiting
Christos CHOUAID, MD PhD, Phone: +33 1 49 28 25 16, Email: christos.chouaid@sat.ap-hop-paris.fr
Christos CHOUAID, MD PhD, Principal Investigator

Assistance Publique Hôpitaux de Paris Hôpital Saint Louis, Paris 75010, France; Not yet recruiting
Anne Bergeron-Lafaurie, MD PhD, Phone: +33 1 42 49 41 65, Email: anne.bergeron-lafaurie@sls.aphp.fr
Anne Bergeron-Lafaurie, MD PhD, Principal Investigator

Assistance Publique Hôpitaux de Paris, hôpital TENON, Paris 75020, France; Recruiting
Jacques CADRANEL, MD PhD, Phone: +331 56 01 61 47, Email: jacques.cadranel@tnn.aphp.fr
Jacques CADRANEL, MD PhD, Principal Investigator
François Xavier LESCURE, MD, Sub-Investigator

Centre National de Reference Des Mycobactéries, Paris 75013, France; Active, not recruiting

CHU Bordeaux Hôpital Haut Leveque, Pessac 33604, France; Not yet recruiting
Carine GREIB, MD, Phone: +335 57 65 64 83, Email: carine.greib@chu-bordeaux.fr

CHU Poitiers, Poitiers 86000, France; Not yet recruiting
Cendrine GODET, MD, Phone: +335 49 44 44 22, Email: c.godet@chu-poitiers.fr
Cendrine GODET, MD, Principal Investigator

CHU Reims, Reims 51100, France; Recruiting
Gaëtan Deslee, MD PhD, Phone: +333 26 78 76 09, Email: gdeslee@chu-reims.fr
Gaëtan Deslee, MD PhD, Principal Investigator
Christophe STRADY, MD PhD, Sub-Investigator

CHU de Rennes Hôpital Ponchaillou, Rennes 35033, France; Recruiting
Stéphane JOUNEAU, MD, Phone: +332 99 28 24 78, Email: stephane.jouneau@chu-rennes.fr
Stéphane JOUNEAU, MD, Principal Investigator
Pierre Tattevin, MD, Sub-Investigator

CH de Roubaix, Roubaix 59056, France; Not yet recruiting
François STEENHOUVER, Phone: +333 20 99 31 31, Email: francois.steenhouwer@ch-roubaix.fr
François Steenhouver, MD, Principal Investigator

CHU Rouen, Rouen 76031, France; Recruiting
Jean François MUIR, MD PhD, Phone: +332 32 88 90 83, Email: jean-francois.muir@chu-rouen.fr
Jean-François MUIR, MD PhD, Principal Investigator
Luc THIBERVILLE, MD PhD, Sub-Investigator

CHU de Saint Etienne, Saint Etienne 42055, France; Not yet recruiting
Sofiane Benhadji, MD, Phone: +334 77 82 83 14
Sofiane Benhadji, MD, Principal Investigator

CH de Saint Quentin, Saint Quentin 02100, France; Not yet recruiting
Youcef DOUADI, MD, Phone: +333.23067536, Email: ydouadi@bbox.fr
Youcef Douadi, MD, Principal Investigator

CH Saint-Nazaire, Saint-Nazaire 44606, France; Active, not recruiting

CHU de Strasbourg, Strasbourg 67091, France; Not yet recruiting
Philippe FRAISSE, MD, Phone: +333 69 55 02 09, Email: philippe.fraisse@chru-strasbourg.fr
Philippe FRAISSE, MD, Principal Investigator

Hôpital FOCH, Suresnes 92150, France; Active, not recruiting

CHU Toulouse, Toulouse 31059, France; Not yet recruiting
Sarah ABBES, MD, Phone: +335 67 77 17 75, Email: abbes.s@chu-toulouse.fr
Sarah ABBES, MD, Principal Investigator

CH de Tourcoing, Tourcoing 59208, France; Not yet recruiting
Yazdan Yazdanpanah, MD PhD, Phone: +33 3 20 69 46 17, Email: yyazdanpanah@ch-tourcoing.fr
Yazdan Yazdanpanah, MD PhD, Principal Investigator

CHU Tours Hôpital BRETONNEAU, Tours 37044, France; Not yet recruiting
Sylvain MARCHAND ADAM, MD, Phone: +33 2 47 47 37 87, Email: s.marchandadam@univ-tours.fr
Sylvain MARCHAND ADAM, MD, Principal Investigator
PHILIPPE LANOTTE, MD, Sub-Investigator

CH Troyes, Troyes 10003, France; Recruiting
Fabienne SANLAVILLE, MD PhD, Phone: + 33 3 25 49 70 42, Email: fabienne.sanlaville@ch-troyes.fr
Fabienne SANLAVILLE, MD PhD, Principal Investigator

CH de Valenciennes, Valenciennes 59300, France; Not yet recruiting
Bruno STACH, MD, Phone: +33 3 27 32 53 90, Email: bruno.stach@orange.fr
Bruno STACH, MD, Principal Investigator

CHU Nancy, Vandeuvre Les Nancy 54511, France; Not yet recruiting
Francois CHABOT, MD PhD, Phone: +333 83 15 40 21, Email: f.chabot@chu-nancy.fr
François CHABOT, MD PhD, Principal Investigator

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Starting date: February 2011
Last updated: July 28, 2015