Treatment of Mycobacterium Xenopi Pulmonary Infection (CAMOMY)

Centre Hospitalier Universitaire, Amiens

Status and phase

Completed

Phase 3

Conditions

Atypical; Mycobacterium, Pulmonary, Tuberculous

Treatments

Drug: Clarithromycin

Drug: Moxifloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT01298336

PHRCN10-DR-ANDREJAK-MELLE

Details and patient eligibility

About

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.

Full 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.

Enrollment

92 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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