Treatment of Mycobacterium Xenopi Pulmonary Infection

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Clarithromycin; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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