Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa
NCT ID: NCT06738771
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2025-03-11
2027-01-31
Brief Summary
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Detailed Description
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The ADDICT study is a prospective, multicenter cohort study including unselected patients with DTR P. aeruginosa infection requiring definite intravenous antimicrobial therapy. The primary objective of the study is to investigate the clinical efficacy of available options (new BL/BLI, cefiderocol or older agents such as aminoglycosides and colistin) in this population. Secondary objectives are to compare the clinical and microbiological efficacy of available options in infections due to DTR P. aeruginosa with in vitro susceptibility to more than one last-resort drug, to compare the incidence of non-ecological adverse events observed with these drugs, to assess the incidence of resistance emergence under therapy and to elucidate the molecular mechanisms of resistance emergence, to assess the benefits and risks of combination therapy in this indication, to compare the acquisition rates of multidrug-resistant bacteria other than DTR P. aeruginosa, and Clostridioides difficile infection, to compare Day-28 and in-hospital all-cause mortality rates.
Patients will be recruited in 60 hospital centers contributing to four French networks of research in infectious diseases and critical care (CRICS-TRIGGERSEP, ReaRezo, OutcomeRéa, RENARCI - PROMISE metanetwork). Clinical variables will be collected through an electronic case-report form. DTR P. aeruginosa isolates will be sent to the National Reference Center of Antimicrobial Resistance in P. aeruginosa for centralized analyses (extended antimicrobial susceptibility testing, MLST, whole-genome sequencing of successive isolates if resistance emergence under therapy).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
patients with invasive P. aeruginosa DTR infection requiring definitive intravenous antibiotic therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* Persons deprived of liberty
* Opposition expressed for participation in the study
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Principal Investigators
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Francois BARBIER, Professor
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire d'Orléans
Locations
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CHU Amiens
Amiens, , France
CH Argenteuil
Argenteuil, , France
CH Bayonne
Bayonne, , France
CHU de BESANCON
Besançon, , France
CH Bethune
Béthune, , France
CHU Avicenne
Bobigny, , France
CH Bourgoin-Jallieu
Bourgoin, , France
CH Métropole Savoie
Chambéry, , France
Ch de Chartres
Chartres, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
CHI Créteil
Créteil, , France
CHU Henri Mondor
Créteil, , France
CHI Elbeuf Louviers
Elbeuf, , France
CH Sud Essone
Étampes, , France
Hopital Raymond Poincaré
Garches, , France
CHU Grenoble
Grenoble, , France
CH Haguenau
Haguenau, , France
CHD Vendée
La Roche-sur-Yon, , France
Hopital Bicetre
Le Kremlin-Bicêtre, , France
CHU Limoges
Limoges, , France
CHU Lyon Sud
Lyon, , France
CHU Lyon
Lyon, , France
CHY Lyon
Lyon, , France
Hopital Saint-Joseph Saint Luc
Lyon, , France
CHU Montpellier
Montpellier, , France
CHRU Nancy
Nancy, , France
Chu de Nantes
Nantes, , France
CHU de Nice
Nice, , France
Centre Hospitalier Universitaire d'Orléans
Orléans, , France
Hopital Bichat
Paris, , France
Hopital Cochin
Paris, , France
Hopital LARIBOISIERE
Paris, , France
Hopital Pitie Salpetriere
Paris, , France
Hopital Saint-Antoine
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Saint-Louis
Paris, , France
CH PAU
Pau, , France
CH Perpignan
Perpignan, , France
Centre Hospitalier de Périgueux
Périgueux, , France
CHU Reims
Reims, , France
CH Saint-Lô
Saint-Lô, , France
CHRU Strasbourg Haute Pierre
Strasbourg, , France
CHU Strasbourg
Strasbourg, , France
Hopital Foch
Suresnes, , France
CH Tourcoing
Tourcoing, , France
CH Vannes
Vannes, , France
Hôpital Nord-Ouest de Villefranche sur Saone
Villefranche-sur-Saône, , France
CHU La Réunion
Saint-Denis, , Reunion
Countries
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Central Contacts
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Facility Contacts
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Stéphanie MALAQUIN, Dr
Role: primary
Olivier PAJOT, Dr
Role: primary
Marc-Olivier VAREIL, Dr
Role: primary
Catherine CHIROUZE, Pr
Role: primary
Sophie NGUYEN, Dr
Role: primary
Khalil CHAIBI, Dr
Role: primary
Abdelhamid FATAH, Dr
Role: primary
Emmanuel FORESTIER, Dr
Role: primary
Juliette AUDIBERT, Dr
Role: primary
Claire DUPUIS, Pr
Role: primary
Rusel LEON, Dr
Role: primary
Keyvan RAZAZI, Pr
Role: primary
Christian CAILLARD, Dr
Role: primary
Siami SHIDASP, Dr
Role: primary
Aurélien DINH, Pr
Role: primary
Hugo PIROLLET, Dr
Role: primary
Thomas GUIMARD, Dr
Role: primary
Leila ESCAUT, Dr
Role: primary
Julien VAIDIE, Dr
Role: primary
Arnaud FRIGGERI, Pr
Role: primary
Laurent ARGAUD, Pr
Role: primary
Jean-Christophe RICHARD, Pr
Role: primary
Emmanuel VIVIER, Dr
Role: primary
Vincent LE MOING, Pr
Role: primary
Benjamin LEFEVRE, Dr
Role: primary
David BOUTOILLE, Pr
Role: primary
Alexandre ROBERT, Dr
Role: primary
Jean-François TIMSIT, Pr
Role: primary
Antoine BOIS, Dr
Role: primary
Anne-Lise MUNIER, Dr
Role: primary
Charles-Edouard LUYT, Pr
Role: primary
Laure SURGERS, Dr
Role: primary
Damien BLEZ, Dr
Role: primary
Matthieu LAFAURIE, Dr
Role: primary
Mélanie LEHOUX, Dr
Role: primary
Hugues AUMAITRE, Dr
Role: primary
Mélanie SAINT-LEGER, Dr
Role: primary
Marin MOUTEL, Dr
Role: primary
Alexandre ALLAIRE, Dr
Role: primary
Ferhat MEZIANI, Dr
Role: primary
Marie-Alice COLOMBIER, Dr
Role: primary
Serge ALFANDARI, Dr
Role: primary
Florian REIZINE, Dr
Role: primary
Gary DAVID, Dr
Role: primary
Kévin DIALLO, Dr
Role: primary
References
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Tamma PD, Aitken SL, Bonomo RA, Mathers AJ, van Duin D, Clancy CJ. Infectious Diseases Society of America 2022 Guidance on the Treatment of Extended-Spectrum beta-lactamase Producing Enterobacterales (ESBL-E), Carbapenem-Resistant Enterobacterales (CRE), and Pseudomonas aeruginosa with Difficult-to-Treat Resistance (DTR-P. aeruginosa). Clin Infect Dis. 2022 Aug 25;75(2):187-212. doi: 10.1093/cid/ciac268.
Hu F, Guo Y, Yang Y, Zheng Y, Wu S, Jiang X, Zhu D, Wang F; China Antimicrobial Surveillance Network (CHINET) Study Group. Resistance reported from China antimicrobial surveillance network (CHINET) in 2018. Eur J Clin Microbiol Infect Dis. 2019 Dec;38(12):2275-2281. doi: 10.1007/s10096-019-03673-1. Epub 2019 Sep 2.
Karlowsky JA, Lob SH, Kazmierczak KM, Young K, Motyl MR, Sahm DF. In-vitro activity of imipenem/relebactam and key beta-lactam agents against Gram-negative bacilli isolated from lower respiratory tract infection samples of intensive care unit patients - SMART Surveillance United States 2015-2017. Int J Antimicrob Agents. 2020 Jan;55(1):105841. doi: 10.1016/j.ijantimicag.2019.10.022. Epub 2019 Nov 6.
Rosenthal VD, Bat-Erdene I, Gupta D, Belkebir S, Rajhans P, Zand F, Myatra SN, Afeef M, Tanzi VL, Muralidharan S, Gurskis V, Al-Abdely HM, El-Kholy A, AlKhawaja SAA, Sen S, Mehta Y, Rai V, Hung NV, Sayed AF, Guerrero-Toapanta FM, Elahi N, Morfin-Otero MDR, Somabutr S, De-Carvalho BM, Magdarao MS, Velinova VA, Quesada-Mora AM, Anguseva T, Ikram A, Aguilar-de-Moros D, Duszynska W, Mejia N, Horhat FG, Belskiy V, Mioljevic V, Di-Silvestre G, Furova K, Gamar-Elanbya MO, Gupta U, Abidi K, Raka L, Guo X, Luque-Torres MT, Jayatilleke K, Ben-Jaballah N, Gikas A, Sandoval-Castillo HR, Trotter A, Valderrama-Beltran SL, Leblebicioglu H; International Nosocomial Infection Control Consortium. International Nosocomial Infection Control Consortium (INICC) report, data summary of 45 countries for 2012-2017: Device-associated module. Am J Infect Control. 2020 Apr;48(4):423-432. doi: 10.1016/j.ajic.2019.08.023. Epub 2019 Oct 29.
Sader HS, Streit JM, Carvalhaes CG, Huband MD, Shortridge D, Mendes RE, Castanheira M. 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). JAC Antimicrob Resist. 2021 Sep 2;3(3):dlab117. doi: 10.1093/jacamr/dlab117. eCollection 2021 Sep.
Hu F, Yuan L, Yang Y, Xu Y, Huang Y, Hu Y, Ai X, Zhuo C, Su D, Shan B, Du Y, Yu Y, Lin J, Sun Z, Chen Z, Xu Y, Zhang X, Wang C, He L, Ni Y, Zhang Y, Lin D, Zhu D, Zhang Y. A multicenter investigation of 2,773 cases of bloodstream infections based on China antimicrobial surveillance network (CHINET). Front Cell Infect Microbiol. 2022 Dec 15;12:1075185. doi: 10.3389/fcimb.2022.1075185. eCollection 2022.
Tabah A, Buetti N, Staiquly Q, Ruckly S, Akova M, Aslan AT, Leone M, Conway Morris A, Bassetti M, Arvaniti K, Lipman J, Ferrer R, Qiu H, Paiva JA, Povoa P, De Bus L, De Waele J, Zand F, Gurjar M, Alsisi A, Abidi K, Bracht H, Hayashi Y, Jeon K, Elhadi M, Barbier F, Timsit JF; EUROBACT-2 Study Group, ESICM, ESCMID ESGCIP and the OUTCOMEREA Network. Epidemiology and outcomes of hospital-acquired bloodstream infections in intensive care unit patients: the EUROBACT-2 international cohort study. Intensive Care Med. 2023 Feb;49(2):178-190. doi: 10.1007/s00134-022-06944-2. Epub 2023 Feb 10.
Other Identifiers
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2023-HORS RIPH-11
Identifier Type: -
Identifier Source: org_study_id
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