Treatment of Mycobacterium Xenopi Pulmonary Infection (CAMOMY)

November 17, 2025 updated by: Centre Hospitalier Universitaire, Amiens

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80142
        • CH Abbeville
      • Amiens, France, 80054
        • CHU Amiens
      • Angers, France, 49033
        • CHU Angers
      • Argenteuil, France, 95100
        • CH Argenteuil
      • Besançon, France, 25030
        • CHU Besancon
      • Bobigny, France, 93009
        • Assistance Publique Hôpitaux de Paris CHU Avicenne
      • Brest, France, 29609
        • CHU Brest La Cavale
      • Béthune, France, 62408
        • CH Bethune
      • Caen, France, 14033
        • CHU Caen
      • Cannes, France, 06401
        • CH Cannes
      • Clermont-Ferrand, France, 63000
        • CHU Clermont Ferrand Hôpital Gabriel Mont pied
      • Corbeil-Essonnes, France, 91100
        • CH Sud Francilien
      • Créteil, France, 94010
        • Centre Intercommunal de Créteil
      • Dijon, France, 21079
        • CHU Dijon
      • Gonesse, France, 95503
        • CH Gonesse
      • Grenoble, France, 38043
        • CHU Grenoble
      • Le Kremlin-Bicêtre, France, 94275
        • Assistance Publique Hôpitaux de Paris Hôpital Bicetre
      • Le Mans, France, 72037
        • CH Le Mans
      • Lille, France, 59037
        • CHU Lille Hôpital Calmette
      • Limoges, France, 87042
        • CHU Limoges Hôpital de Cluzeau
      • Lyon, France, 69004
        • CHU Lyon Hôpital La Croix Rousse
      • Marseille, France, 13008
        • Höpital Saint-Joseph
      • Marseille, France, 13009
        • Assistance Publique Hopitaux de Marseille
      • Montpellier, France, 34295
        • CHU Montpellier Hôpital Arnaud de Villeneuve
      • Nantes, France, 44000
        • CHU Nantes
      • Nice, France, 06002
        • CHU Nice
      • Orléans, France, 45067
        • CHR Orléans
      • Paris, France, 75010
        • Assistance Publique Hôpitaux de Paris Hôpital Saint Louis
      • Paris, France, 75012
        • Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine
      • Paris, France, 75018
        • Assistance Publique Hôpitaux de Paris Hôpital BICHAT
      • Paris, France, 75020
        • Assistance Publique Hôpitaux de Paris, hôpital TENON
      • Pessac, France, 33604
        • CHU Bordeaux Hopital Haut Leveque
      • Poitiers, France, 86000
        • CHU Poitiers
      • Pontoise, France, 95300
        • Hôpital René Dubos
      • Reims, France, 51100
        • CHU Reims
      • Rennes, France, 35033
        • CHU de Rennes Hôpital Ponchaillou
      • Roubaix, France, 59056
        • CH de Roubaix
      • Rouen, France, 76031
        • CHU Rouen
      • Saint-Etienne, France, 42055
        • Chu de Saint Etienne
      • Saint-Quentin, France, 02100
        • CH de Saint Quentin
      • Strasbourg, France, 67091
        • CHU de Strasbourg
      • Suresnes, France, 92150
        • Hopital Foch
      • Toulouse, France, 31059
        • CHU Toulouse
      • Tourcoing, France, 59208
        • CH de Tourcoing
      • Tours, France, 37044
        • Chu Tours Hopital Bretonneau
      • Valenciennes, France, 59300
        • Ch de Valenciennes
      • Vandœuvre-lès-Nancy, France, 54511
        • CHU Nancy
    • Compiègne
      • Compiègne, Compiègne, France, 60321
        • CH Compiègne
    • Les Mureaux
      • Les Mureaux, Les Mureaux, France, 78250
        • CH Intercommunal Meulan
    • PARIS
      • Paris, PARIS, France, 75013
        • Centre National de Reference Des Mycobactéries
    • Saint-Nazaire
      • Saint-Nazaire, Saint-Nazaire, France, 44606
        • CH Saint-Nazaire
    • Troyes
      • Troyes, Troyes, France, 10003
        • CH Troyes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moxifloxacin
Drug: Moxifloxacin
400 mg per day seven days a week
Other Names:
  • IZILOX
Experimental: Clarithromycin
Drug: Clarithromycin
500 mg twice a day seven days a week
Other Names:
  • ZECLAR, NAXY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sputum conversion at 6 months under three antibiotics treatment (Rifampin, ethambutol and a third drug clarithromycin or moxifloxacin)
Time Frame: 6 months
Results of the smear and culture of three respiratory samples after 6 months of treatment.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
12 months
Clinical and radiological outcome after 3, 6 and 12 months of treatment according to the treatment arm
Time Frame: 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
12 months
Mortality after 12 months of treatment in the two compared regimen
Time Frame: 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
12 months
Gastrointestinal toxicity and hematotoxicity after 1- 3- 6- 9- 12- months of treatment
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2011

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimated)

February 17, 2011

Study Record Updates

Last Update Posted (Estimated)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRCN10-DR-ANDREJAK-MELLE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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