CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections

Who is this study for? Patients with mycobacterium avium complex lung infections
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

MAC lung infections are a growing public health problem. The ATS / IDSA 2007 guidelines for the treatment of these non-tuberculous mycobacterial infections recommend the use of a macrolide or azalide (clarithromycin or azithromycin), rifampicin or rifabutin and ethambutol. For MAC disseminated infections, several studies have compared combinations containing clarithromycin or azithromycin and found no significant difference in efficacy. No randomized controlled trials have been performed for pulmonary infections to compare clarithromycin and azithromycin in terms of efficacy. Clarithromycin is often used as a first-line treatment in France, but its tolerance is often poor, particularly in terms of risk of hepatitis, metallic taste in the mouth, nausea or vomiting, and it interacts with many drugs via cytochrome p450 . In particular, it increases the toxicity of rifabutin, in particular in terms of uveitis. Azithromycin has fewer side effects especially less digestive toxicity and drug interactions than clarithromycin. The hypothesis is therefore that the efficacy of azithromycin would be non-inferior in comparison with that of clarithromycin.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patients 18 years of age or older

• having a positive Mycobacterium avium complex sample showing the ATS / IDSA infection criteria and requiring treatment

• ATS / IDSA infection criteria combine clinico-radiological criteria, associated with microbiological criteria

• the exclusion of any other diagnosis on the thoracic CT, fibroscopy and bacteriological samples

Locations
Other Locations
France
CHU Amiens Picardie
NOT_YET_RECRUITING
Amiens
CHU Angers
RECRUITING
Angers
Saint Joseph Hospital
RECRUITING
Marseille
Contact Information
Primary
Claire ANDREJAK, PhD
andrejak.claire@chu-amiens.fr
+33322087893
Time Frame
Start Date: 2018-02-05
Estimated Completion Date: 2029-02-05
Participants
Target number of participants: 424
Treatments
Active_comparator: Clarithromycin 1000 MG
The patient will received a combination of 3 antibiotics :~* Rifampicin (10mg/kg once daily)~* Ethambutol (15 to 20 mg/kg once daily)~* Clarithromycin (500 mg twice daily)
Experimental: Azithromycin 250 MG
The patient will received a combination of 3 antibiotics :~* Rifampicin (10mg/kg once daily)~* Ethambutol (15 to 20 mg/kg once daily)~* Azithromycin (250 mg once daily)
Sponsors
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov