Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Antimicrobial Therapy for Infections Due to Pseudomonas Aeruginosa With Difficult-to-treat Resistance: a Real-world, Prospective, Multicenter Cohort Study

ClinicalTrials.gov ID

NCT06738771

Acronym / sponsor ID

ADDICT / 2023-HORS RIPH-11

Conditions

Pseudomonas Infections, Pseudomonas Aeruginosa, Prognosis, Drug Resistance, Multiple, Bacterial, Antibacterial Agents, Beta-lactam Antibiotics

Study type

Observational

Recruitment status

Recruiting

Enrolment

600 participants (estimated)

Lead sponsor

Centre Hospitalier Régional d'OrléansUniversity, hospital or other

Study start

11 Mar 2025 (actual)

Primary completion

Jan 2027 (estimated)

Study completion

Jan 2027 (estimated)

First posted

18 Dec 2024 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Prospective multicenter cohort

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Clinical cure rate

   Time frame: Test of cure visit

   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).

2. Clinical cure

   Time frame: Day 7±2 after the completion of definite therapy

   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).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
• Background: PubMed 35439291Tamma 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.
• Background: PubMed 31478103Hu 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.
• Background: PubMed 31704217Karlowsky 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.
• Background: PubMed 31676155Rosenthal 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.
• Background: PubMed 34671728Sader 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.
• Background: PubMed 36590586Hu 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.
• Background: PubMed 36764959Tabah 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

48 sites in 2 countries: see every site and its status.