The primary objective of the ADDICT study is to assess and compare the clinical efficacy of available options for antimicrobial therapy (new beta-lactam/beta-lactamase inhibitor combination, cefiderocol or older agents such as aminoglycosides and colistin) in unselected patients with infection due to difficult-to-treat P. aeruginosa.
All patients aged 18 or over and requiring intravenous definite antimicrobial therapy for a DTR P. aeruginosa infection
Cystic fibrosis
P. aeruginosa DTR colonization or P. aeruginosa DTR infection not requiring definitive intravenous antibiotic therapy
Protected person (under guardianship or curatorship)
Persons under court protection
Prospective multicenter cohort
Cohort
Prospective
Not listed
Clinical cure rate
Clinical responses will be assessed by local investigators. Clinical cure will be defined as a composite endpoint of survival with no relapse occurring since the end of definite therapy and the complete resolution of all initial clinical signs of infection at the ToC visit (all-cause deaths at the ToC visit will be considered as clinical failures).
Clinical cure
Clinical responses will be assessed by local investigators. Clinical cure will be defined as a composite endpoint of survival with no relapse occurring since the end of definite therapy and the complete resolution of all initial clinical signs of infection at the ToC visit (all-cause deaths at the ToC visit will be considered as clinical failures).
Microbiological eradication
Negativation of cultures for DTR P. aeruginosa in participants with at least one collected follow-up bacteriological sample (when clinically indicated) before the ToC visit
Resistance emergence
Any culture growing a DTR P. aeruginosa isolate with resistance to at least one new antimicrobial agent (compared to the first isolate) between the second day of definite therapy and hospital discharge
Non-ecological adverse events
Any toxicity or allergic reaction attributed to the antimicrobial agent by the local investigator
Non-ecological adverse events
Any toxicity or allergic reaction attributed to the antimicrobial agent by the local investigator
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