Antimicrobial Therapy for Infections Due to Pseudomonas Aeruginosa With Difficult-to-treat Resistance: a Real-world, Prospective, Multicenter Cohort Study
Led by Centre Hospitalier Régional d'Orléans · Updated on 2026-04-30
600
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48
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N/A
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What this Trial Is About
Researchers are evaluating different antimicrobial therapies for infections caused by difficult-to-treat Pseudomonas aeruginosa, a type of bacteria resistant to many common antibiotics. This study focuses on comparing new beta-lactam/beta-lactamase inhibitor combinations, cefiderocol, and older treatments like aminoglycosides and colistin to understand their effectiveness in real-life settings for patients facing these challenging infections.
The study is a prospective, multicenter cohort involving patients who require intravenous antibiotic treatment for their P. aeruginosa infections. Participating patients will receive one of the available antimicrobial options, and their bacterial samples will be analyzed centrally to assess susceptibility and resistance mechanisms. The study collects clinical data throughout treatment and monitors outcomes such as cure rates, resistance development, adverse events, and mortality.
Participants will be followed until hospital discharge and up to 28 days after treatment completion. Researchers will track clinical cures, microbiological eradication, adverse events, emergence of resistance, and acquisition of other multidrug-resistant bacteria. Data collection includes electronic case reports and laboratory testing on bacterial isolates. The total participation duration varies according to hospital stay and follow-up schedules, with rigorous monitoring of safety and treatment outcomes.
CONDITIONS
Brief Title
Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa
Pseudomonas aeruginosa difficult-to-treat resistance colonization or infection not requiring definitive intravenous antibiotic therapy
Persons under guardianship or curatorship
Persons under court protection
Persons deprived of liberty
Individuals who oppose participation in the study
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to hospital discharge, an average of 1 month
Participants who undergo routine care for difficult-to-treat Pseudomonas aeruginosa infection are observed while receiving definitive intravenous antibiotic therapy.
Follow-up
Duration - Up to 28 days after completion of therapy
Participants are assessed at the test-of-cure visit approximately 7 days after completing definitive therapy to evaluate clinical cure and adverse events, and survival is monitored up to Day 28.
1 visit (in-person) at test-of-cure and additional monitoring until Day 28
Infectious Diseases Society of America 2022 Guidance on the Treatment of Extended-Spectrum β-lactamase Producing Enterobacterales (ESBL-E), Carbapenem-Resistant Enterobacterales (CRE), and Pseudomonas aeruginosa with Difficult-to-Treat Resistance (DTR-P. aeruginosa).
Pranita D Tamma, Samuel L Aitken, Robert A Bonomo...
In-vitro activity of imipenem/relebactam and key β-lactam agents against Gram-negative bacilli isolated from lower respiratory tract infection samples of intensive care unit patients - SMART Surveillance United States 2015-2017.
James A Karlowsky, Sibylle H Lob, Krystyna M Kazmierczak...
Frequency of occurrence and antimicrobial susceptibility of bacteria isolated from respiratory samples of patients hospitalized with pneumonia in Western Europe, Eastern Europe and the USA: results from the SENTRY Antimicrobial Surveillance Program (2016-19).
Helio S Sader, Jennifer M Streit, Cecilia G Carvalhaes...