Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa
ADDICT
Antimicrobial Therapy for Infections Due to Pseudomonas Aeruginosa With Difficult-to-treat Resistance: a Real-world, Prospective, Multicenter Cohort Study
1 other identifier
observational
600
2 countries
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2024
CompletedFirst Posted
Study publicly available on registry
December 18, 2024
CompletedStudy Start
First participant enrolled
March 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 30, 2026
April 1, 2026
1.8 years
November 26, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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).
Test of cure visit
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).
Day 7±2 after the completion of definite therapy
Secondary Outcomes (8)
Microbiological eradication
Day 7
Resistance emergence
Up to hospital discharge, an average of 1 month
Non-ecological adverse events
At test-of-cure visit, 7±2 days after the completion of definite therapy
Non-ecological adverse events
From the first day of definite therapy to the ToC visit
Acquisition of multidrug-resistant bacteria other than DTR P. aeruginosa
Up to hospital discharge, an average of 1 month
- +3 more secondary outcomes
Study Arms (1)
1
patients with invasive P. aeruginosa DTR infection requiring definitive intravenous antibiotic therapy
Eligibility Criteria
Prospective multicenter cohort
You may qualify if:
- All patients aged 18 or over and requiring intravenous definite antimicrobial therapy for a DTR P. aeruginosa infection
You may not qualify if:
- 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
- Persons deprived of liberty
- Opposition expressed for participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
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
Related Publications (7)
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.
PMID: 35439291BACKGROUNDHu 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.
PMID: 31478103BACKGROUNDKarlowsky 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.
PMID: 31704217BACKGROUNDRosenthal 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.
PMID: 31676155BACKGROUNDSader 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.
PMID: 34671728BACKGROUNDHu 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.
PMID: 36590586BACKGROUNDTabah 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.
PMID: 36764959BACKGROUND
Biospecimen
DTR P. aeruginosa isolates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francois BARBIER, Professor
Centre Hospitalier Universitaire d'Orléans
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2024
First Posted
December 18, 2024
Study Start
March 11, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04