Actively Recruiting

Age: 18Years +
All Genders
ID06738771

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

Participants Needed

48

Research Sites

N/A

Total Duration

On this page

AI-Summary

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Patients requiring intravenous definite antimicrobial therapy for difficult-to-treat Pseudomonas aeruginosa infection
Not Eligible

You will not qualify if you...

  • Diagnosis of cystic fibrosis
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 48 locations

1

CHU Amiens

Amiens, France

Not Yet Recruiting

2

CH Argenteuil

Argenteuil, France

Not Yet Recruiting

3

CH Bayonne

Bayonne, France

Not Yet Recruiting

4

CHU de BESANCON

Besançon, France

Not Yet Recruiting

5

CH Bethune

Béthune, France

Not Yet Recruiting

6

CHU Avicenne

Bobigny, France

Not Yet Recruiting

7

CH Bourgoin-Jallieu

Bourgoin, France

Not Yet Recruiting

8

CH Métropole Savoie

Chambéry, France

Not Yet Recruiting

9

Ch de Chartres

Chartres, France

Not Yet Recruiting

10

CHU Clermont Ferrand

Clermont-Ferrand, France

Not Yet Recruiting

11

CHI Créteil

Créteil, France

Not Yet Recruiting

12

CHU Henri Mondor

Créteil, France

Not Yet Recruiting

13

CHI Elbeuf Louviers

Elbeuf, France

Not Yet Recruiting

14

CH Sud Essone

Étampes, France

Not Yet Recruiting

15

Hopital Raymond Poincaré

Garches, France

Not Yet Recruiting

16

CHU Grenoble

Grenoble, France

Not Yet Recruiting

17

CH Haguenau

Haguenau, France

Not Yet Recruiting

18

CHD Vendée

La Roche-sur-Yon, France

Actively Recruiting

19

Hopital Bicetre

Le Kremlin-Bicêtre, France

Not Yet Recruiting

20

CHU Limoges

Limoges, France

Not Yet Recruiting

21

CHU Lyon Sud

Lyon, France

Not Yet Recruiting

22

CHU Lyon

Lyon, France

Not Yet Recruiting

23

CHY Lyon

Lyon, France

Not Yet Recruiting

24

Hopital Saint-Joseph Saint Luc

Lyon, France

Not Yet Recruiting

25

CHU Montpellier

Montpellier, France

Not Yet Recruiting

26

CHRU Nancy

Nancy, France

Actively Recruiting

27

Chu de Nantes

Nantes, France

Not Yet Recruiting

28

CHU de Nice

Nice, France

Not Yet Recruiting

29

Centre Hospitalier Universitaire d'Orléans

Orléans, France

Actively Recruiting

30

Hopital Bichat

Paris, France

Actively Recruiting

31

Hopital Cochin

Paris, France

Not Yet Recruiting

32

Hopital LARIBOISIERE

Paris, France

Not Yet Recruiting

33

Hopital Pitie Salpetriere

Paris, France

Not Yet Recruiting

34

Hopital Saint-Antoine

Paris, France

Not Yet Recruiting

35

Hôpital Européen Georges Pompidou

Paris, France

Not Yet Recruiting

36

Hôpital Saint-Louis

Paris, France

Not Yet Recruiting

37

CH PAU

Pau, France

Not Yet Recruiting

38

CH Perpignan

Perpignan, France

Not Yet Recruiting

39

Centre Hospitalier de Périgueux

Périgueux, France

Not Yet Recruiting

40

CHU Reims

Reims, France

Not Yet Recruiting

41

CH Saint-Lô

Saint-Lô, France

Not Yet Recruiting

42

CHRU Strasbourg Haute Pierre

Strasbourg, France

Not Yet Recruiting

43

CHU Strasbourg

Strasbourg, France

Not Yet Recruiting

44

Hopital Foch

Suresnes, France

Not Yet Recruiting

45

CH Tourcoing

Tourcoing, France

Not Yet Recruiting

46

CH Vannes

Vannes, France

Not Yet Recruiting

47

Hôpital Nord-Ouest de Villefranche sur Saone

Villefranche-sur-Saône, France

Not Yet Recruiting

48

CHU La Réunion

Saint-Denis, Reunion

Not Yet Recruiting

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Research Team

F

FRANCOIS BARBIER, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/35439291

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...

https://pubmed.ncbi.nlm.nih.gov/31704217

International Nosocomial Infection Control Consortium (INICC) report, data summary of 45 countries for 2012-2017: Device-associated module.

Víctor Daniel Rosenthal, Ider Bat-Erdene, Debkishore Gupta...

https://pubmed.ncbi.nlm.nih.gov/31676155

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...

https://pubmed.ncbi.nlm.nih.gov/34671728

A multicenter investigation of 2,773 cases of bloodstream infections based on China antimicrobial surveillance network (CHINET).

Fupin Hu, Lili Yuan, Yang Yang...

https://pubmed.ncbi.nlm.nih.gov/36590586

Epidemiology and outcomes of hospital-acquired bloodstream infections in intensive care unit patients: the EUROBACT-2 international cohort study.

Alexis Tabah, Niccolò Buetti, Quentin Staiquly...

https://pubmed.ncbi.nlm.nih.gov/36764959