Treatment of Mycobacterium Xenopi Pulmonary Infection (CAMOMY)
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|ClinicalTrials.gov Identifier: NCT01298336|
Recruitment Status : Recruiting
First Posted : February 17, 2011
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atypical; Mycobacterium, Pulmonary, Tuberculous||Drug: Clarithromycin Drug: Moxifloxacin||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi|
|Actual Study Start Date :||March 2, 2011|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
500 mg twice a day seven days a week
Other Name: ZECLAR, NAXY
400 mg per day seven days a week
Other Name: IZILOX
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298336
|Contact: Claire ANDREJAK, Dr||+33 3 22 45 59 email@example.com|
|Contact: Sophie Liabeuf, Pr||+33 3 22 45 60 firstname.lastname@example.org|
|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|