RecruitingPhase 3

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

France424 participantsStarted 2018-02-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Known hypersensitivity to one of the study molecules (rifampicin, ethambutol, azithromycin, clarithromycin) * Relapse of an MAC infection, * Strain resistant to macrolides, based on genotyping susceptibility testing (genotyping susceptibility testing must be done before inclusion) * Treatment that interacts with cytochrome p450 that can not be replaced by another therapeutic, * HIV serology 1 and 2, * Renal insufficiency with creatinine clearance less than 30 ml / min, * Pregnancy and breast feeding, * Contra-indication to one of the antibiotics, * Impossibility to follow the protocol due in particular to drug addiction according to the investigator, * Limited life expectancy, less than 6 months, * Patient already participating in a clinical trial on a medical treatment or a therapeutic strategy for non-tuberculous mycobacteria.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Culture results of respiratory specimens taken 6 months after starting treatment.

Timeframe: 6 months

Trial details

NCT IDNCT03236987

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-05

Contact for this trial

Claire ANDREJAK, PhD

+33322087893 andrejak.claire@chu-amiens.fr

View on ClinicalTrials.gov More Lung Infection trials