Atypical; Mycobacterium, Pulmonary, Tuberculous Clinical Trial
Official title:
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.
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.
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