Last updated on August 2018

Treatment of Mycobacterium Xenopi Pulmonary Infection

Brief description of study

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 Study 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 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.

Clinical Study Identifier: NCT01298336

Find a site near you

Start Over

CH Argenteuil

Argenteuil, France
  Connect »

CH Sud Francilien

Corbeil-Essonnes, France
  Connect »

CH Abbeville

Abbeville, France
  Connect »


Le Mans, France
  Connect »

CH de Tourcoing

Tourcoing, France
  Connect »

CHU Dijon

Dijon, France
  Connect »

CHU Reims

Reims, France
  Connect »

CHU Toulouse

Toulouse, France
  Connect »

CH Cannes

Cannes, France
  Connect »

CH Compi gne

Compiègne, France
  Connect »

CHU Nantes

Nantes, France
  Connect »

CH de Saint Quentin

Saint Quentin, France
  Connect »

CH Gonesse

Gonesse, France
  Connect »

CHU Amiens

Amiens, France
  Connect »

H pital FOCH

Suresnes, France
  Connect »

CH de Valenciennes

Valenciennes, France
  Connect »

CHU Poitiers

Poitiers, France
  Connect »

CHU Angers

Angers, France
  Connect »

CH B thune

Béthune, France
  Connect »

CH Troyes

Troyes, France
  Connect »

CHU Grenoble

Grenoble, France
  Connect »

CHU Rouen

Rouen, France
  Connect »

CHU de Saint Etienne

Saint Etienne, France
  Connect »

CH Saint-Nazaire

Saint-Nazaire, France
  Connect »

CHU Besan on

Besançon, France
  Connect »

Chr Orleans

Orléans, France
  Connect »

CHU Nancy

Vandœuvre-lès-Nancy, France
  Connect »