Treatment of Mycobacterium Xenopi Pulmonary Infection

NCT01298336 | Completed Phase 3 DMC

• 1 other identifier: PHRCN10-DR-ANDREJAK-MELLE
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 52

Brief Summary

The purpose of this study is to determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary infection.

Conditions

Atypical; Mycobacterium, Pulmonary, Tuberculous

Keywords

Mycobacterium Xenopi Pulmonary Infection; Clarithromycin; Moxifloxacin

Outcome Measures

Primary Outcomes (1)

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

  Results of the smear and culture of three respiratory samples after 6 months of treatment.

  6 months

Secondary Outcomes (4)

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

  12 months

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

  12 months

• Mortality after 12 months of treatment in the two compared regimen

  12 months

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

  12 months

Study Arms (2)

Clarithromycin

EXPERIMENTAL

Drug: Clarithromycin

Moxifloxacin

EXPERIMENTAL

Drug: Moxifloxacin

Interventions

Clarithromycin DRUG

500 mg twice a day seven days a week

Also known as: ZECLAR, NAXY

Clarithromycin

Moxifloxacin DRUG

400 mg per day seven days a week

Also known as: IZILOX

Moxifloxacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (52)

CH Compiègne

Compiègne, Compiègne, 60321, France

Location

CH Intercommunal Meulan

Les Mureaux, Les Mureaux, 78250, France

Location

Centre National de Reference Des Mycobactéries

Paris, PARIS, 75013, France

Location

CH Saint-Nazaire

Saint-Nazaire, Saint-Nazaire, 44606, France

Location

CH Troyes

Troyes, Troyes, 10003, France

Location

CH Abbeville

Abbeville, 80142, France

Location

CHU Amiens

Amiens, 80054, France

Location

CHU Angers

Angers, 49033, France

Location

CH Argenteuil

Argenteuil, 95100, France

Location

CHU Besançon

Besançon, 25030, France

Location

CH Béthune

Béthune, 62408, France

Location

Assistance Publique Hôpitaux de Paris CHU Avicenne

Bobigny, 93009, France

Location

CHU Brest La Cavale

Brest, 29609, France

Location

CHU Caen

Caen, 14033, France

Location

CH Cannes

Cannes, 06401, France

Location

CHU Clermont Ferrand Hôpital Gabriel Mont pied

Clermont-Ferrand, 63000, France

Location

CH Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Centre Intercommunal de Créteil

Créteil, 94010, France

Location

CHU Dijon

Dijon, 21079, France

Location

CH Gonesse

Gonesse, 95503, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

Assistance Publique Hôpitaux de Paris Hôpital Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

CH Le MANS

Le Mans, 72037, France

Location

CHU Lille Hôpital Calmette

Lille, 59037, France

Location

CHU Limoges Hôpital de Cluzeau

Limoges, 87042, France

Location

CHU Lyon Hôpital La Croix Rousse

Lyon, 69004, France

Location

Hopital Saint-Joseph

Marseille, 13008, France

Location

Assistance Publique Hôpitaux de Marseille

Marseille, 13009, France

Location

CHU Montpellier Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHU Nantes

Nantes, 44000, France

Location

CHU Nice

Nice, 06002, France

Location

Chr Orleans

Orléans, 45067, France

Location

Assistance Publique Hôpitaux de Paris Hôpital Saint Louis

Paris, 75010, France

Location

Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine

Paris, 75012, France

Location

Assistance Publique Hôpitaux de Paris Hôpital BICHAT

Paris, 75018, France

Location

Assistance Publique Hôpitaux de Paris, hôpital TENON

Paris, 75020, France

Location

CHU Bordeaux Hôpital Haut Leveque

Pessac, 33604, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

Hopital René DUBOS

Pontoise, 95300, France

Location

CHU Reims

Reims, 51100, France

Location

CHU de Rennes Hôpital Ponchaillou

Rennes, 35033, France

Location

CH de Roubaix

Roubaix, 59056, France

Location

CHU Rouen

Rouen, 76031, France

Location

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

CH de Saint Quentin

Saint-Quentin, 02100, France

Location

CHU de Strasbourg

Strasbourg, 67091, France

Location

Hôpital FOCH

Suresnes, 92150, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

CH de Tourcoing

Tourcoing, 59208, France

Location

CHU Tours Hôpital BRETONNEAU

Tours, 37044, France

Location

CH de Valenciennes

Valenciennes, 59300, France

Location

CHU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

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MeSH Terms

Conditions

Mycobacterium Infections; Latent Tuberculosis

Interventions

Clarithromycin; Moxifloxacin

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tuberculosis; Latent Infection

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Claire ANDREJAK, Dr

  Centre Hospitalier Universitaire, Amiens

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 17, 2011
• Study Start: March 2, 2011
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

FR (52)