CLArithromycin versus AZIthromycin in the treatment of Mycobacterium avium complex pulmonary infections: A randomized prospective controlled study

Phase 1

Conditions: Mycobacterium avium complex pulmonary infections
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2017-001087-38-FR

Lead Sponsor: CHU Amiens-Picardie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Clinical criteria
?Respiratory symptoms and the presence of nodular or cavitary lesion on chest x-ray, confirmed on CT-scan. Lesions may also present in the form of diffuse micronodular syndrome.
AND
-Microbiological criteria
?At least two positive cultures for MAC on two sputum specimens obtained on two different days
AND/OR
?Positive culture for MAC on bronchoalveolar lavage or bronchoscopic aspiration
AND/OR
?Transbronchial biopsy or surgical lung biopsy presenting histology in favour of mycobacterial infection and positive culture for MAC OR biopsy showing histology compatible with mycobacterial infection and one or more sputum cultures positive for MAC.
AND
•Exclusion of other diagnoses on CT scan, bronchoscopy and bacteriological specimens.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 424
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Known hypersensitivity to one of the molecules of the study (rifampin, ethambutol, azithromycin, clarithromycin)
-Relapse of MAC lung infection
-Macrolide resistant stain
-Treatment with molecules able to interfere with cytochrome P450 that cannot be replaced by another therapeutic class
-HIV 1 and 2 infection
-Renal failure with creatinine clearance < 30 mL/min
-Pregnancy and breastfeeding
-Contraindications to one of the antibiotic
-Inability to comply with the requirements of the protocol, especially substance abuse, according to the investigator.
-Limited life expectancy (e.g 6 months)
-Patient who has already participated in a clinical trial on medicinal product or treatment strategy for NTM