Clincosm LogoSign in Get a demo

CAMOMY: Treatment of Mycobacterium Xenopi Pulmonary Infection

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT01298336
Collaborator
(none)
92
Enrollment
52
Locations
2
Arms
96
Actual Duration (Months)
1.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi
Actual Study Start Date :
Mar 2, 2011
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Clarithromycin

Drug: Clarithromycin
500 mg twice a day seven days a week
Other Names:
  • ZECLAR, NAXY

    		•
    Experimental: Moxifloxacin

    Drug: Moxifloxacin
    400 mg per day seven days a week
    Other Names:
  • IZILOX

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Secondary Outcome Measures

    1. 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]

      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)

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

      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

    3. Mortality after 12 months of treatment in the two compared regimen [12 months]

      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

    4. Gastrointestinal toxicity and hematotoxicity after 1- 3- 6- 9- 12- months of treatment [12 months]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 CH Abbeville Abbeville France 80142
    2 CHU Amiens Amiens France 80054
    3 CHU Angers Angers France 49033
    4 CH Argenteuil Argenteuil France 95100
    5 CHU Besançon Besançon France 25030
    6 Assistance Publique Hôpitaux de Paris CHU Avicenne Bobigny France 93009
    7 CHU Brest La Cavale Brest France 29609
    8 CH Béthune Béthune France 62408
    9 CHU Caen Caen France 14033
    10 CH Cannes Cannes France 06401
    11 CHU Clermont Ferrand Hôpital Gabriel Mont pied Clermont Ferrand France 63000
    12 CH Compiègne Compiègne France 60321
    13 CH Sud Francilien Corbeil-Essonnes France 91100
    14 Centre Intercommunal de Créteil Creteil France 94010
    15 CHU Dijon Dijon France 21079
    16 CH Gonesse Gonesse France 95503
    17 CHU Grenoble Grenoble France 38043
    18 Assistance Publique Hôpitaux de Paris Hôpital Bicetre Le Kremlin-Bicêtre France 94275
    19 CH Le MANS Le Mans France 72037
    20 CH Intercommunal Meulan Les Mureaux France 78250
    21 CHU Lille Hôpital Calmette Lille France 59037
    22 CHU Limoges Hôpital de Cluzeau Limoges France 87042
    23 CHU Lyon Hôpital La Croix Rousse Lyon France 69004
    24 Hopital Saint-Joseph Marseille France 13008
    25 Assistance Publique Hôpitaux de Marseille Marseille France 13009
    26 CHU Montpellier Hôpital Arnaud de Villeneuve Montpellier France 34295
    27 CHU Nantes Nantes France 44000
    28 CHU Nice Nice France 06002
    29 Chr Orleans Orléans France 45067
    30 Assistance Publique Hôpitaux de Paris Hôpital Saint Louis Paris France 75010
    31 Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine Paris France 75012
    32 Centre National de Reference Des Mycobactéries Paris France 75013
    33 Assistance Publique Hôpitaux de Paris Hôpital BICHAT Paris France 75018
    34 Assistance Publique Hôpitaux de Paris, hôpital TENON Paris France 75020
    35 CHU Bordeaux Hôpital Haut Leveque Pessac France 33604
    36 CHU Poitiers Poitiers France 86000
    37 Hopital René DUBOS Pontoise France 95300
    38 CHU Reims Reims France 51100
    39 CHU de Rennes Hôpital Ponchaillou Rennes France 35033
    40 CH de Roubaix Roubaix France 59056
    41 CHU Rouen Rouen France 76031
    42 CHU de Saint Etienne Saint Etienne France 42055
    43 CH de Saint Quentin Saint Quentin France 02100
    44 CH Saint-Nazaire Saint-Nazaire France 44606
    45 CHU de Strasbourg Strasbourg France 67091
    46 Hôpital FOCH Suresnes France 92150
    47 CHU Toulouse Toulouse France 31059
    48 CH de Tourcoing Tourcoing France 59208
    49 CHU Tours Hôpital BRETONNEAU Tours France 37044
    50 CH Troyes Troyes France 10003
    51 CH de Valenciennes Valenciennes France 59300
    52 CHU Nancy Vandœuvre-lès-Nancy France 54511

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT01298336
    Other Study ID Numbers:
    • PHRCN10-DR-ANDREJAK-MELLE
    First Posted:
    Feb 17, 2011
    Last Update Posted:
    Jul 20, 2020
    Last Verified:
    Jul 1, 2020
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Mycobacterium Xenopi Pulmonary Infection
    Clarithromycin
    Moxifloxacin
    Additional relevant MeSH terms:
    Mycobacterium Infections
    Mycobacterium Infections, Nontuberculous
    Moxifloxacin
    Clarithromycin

    Study Results

    No Results Posted as of Jul 20, 2020