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Compares treatment options for Lung Infection
Official title CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections
ClinicalTrials.gov ID: NCT03236987
What this study is testing
What is Clarithromycin 1000 MG?
Clarithromycin 1000 MG is an investigational medicine, given as an once-weekly inhaled treatment, being studied as a potential treatment for lung infection.
Also referred to as ZECLAR.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 3 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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,
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, Picardie, France
- Angers, France
- Marseille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, Picardie, France; Angers, France; Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.