Clinical Trial: Treatment of Mycobacterium Xenopi Pulmonary Infection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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 trea
Sponsor: Centre Hospitalier Universitaire, Amiens

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current 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 [ 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)
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire, Amiens

Dates:
Date Received: February 15, 2011
Date Started: February 2011
Date Completion: December 2026
Last Updated: January 30, 2017
Last Verified: January 2017