Multicenter Evaluation of the Susceptibility of Enterobacteriaceae and Pseudomonas Aeruginosa to Ceftolozane/Tazobactam Combination

NCT03963297 | Completed

• 1 other identifier: GMC-9
• Study Type: observational
• Target: 747
• Locations: 1 country
• Sites: 1

Brief Summary

Ceftolozane/tazobactam is a new antibiotic with broad spectrum activity. This molecule is currently one of the most active beta lactams against Pseudomonas aeruginosa and its spectrum of activity also includes enterobacteriaceae producing a broad spectrum beta-lactamase (EBLSE). Ceftolozane/tazobactam is currently marketed for the treatment of complicated intra-abdominal infections and complicated urinary tract infections. These intra-abdominal and urinary infections are mainly caused by enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) and more rarely by P. aeruginosa. Concerning enterobacteriaceae, French epidemiology reports a prevalence of BLSE of between 10 and 15% in E. coli and 10%-30% in K. pneumoniae.

Conditions

Antibiotic Resistant Strain

Outcome Measures

Primary Outcomes (1)

• Value of the minimum inhibitory concentration (MIC)

  Value of the minimum inhibitory concentration (MIC) obtained for ceftolozane/tazobactam for each strain

  1 year

Secondary Outcomes (4)

• Patient History

  1 year

• Number of strains producing ESBL and/or carbapenemase (yes or no)

  1 year

• Molecular profil of enterobacteriaceae (produced genes : yes or no)

  1 year

• Molecular profil of pseudomonas aeruginosa (produced genes : yes or no)

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patient with community-acquired or nosocomial Gram-negative bacillus infection of enterobacteriaceae or P. aeruginosa type (bacteremia, low respiratory infection, intra-abdominal infection)

You may qualify if:

• Patient whose age is ≥ 18 years old
• Hospitalized patient with community-acquired or nosocomial Gram-negative bacillus infection of enterobacteriaceae or P. aeruginosa type (bacteremia, low respiratory infection, intra-abdominal infection)
• French-speaking patient

You may not qualify if:

• Patient under tutorship or curatorship
• Patient deprived of liberty
• Patient under the protection of justice
• Refusal to participate in the study
• Patients judged by the investigator as being unable to express their non-opposition to the study
• Urinary localization of the infection to avoid strains responsible for simple colonization. Indeed, the collection of microbiological data (as carried out in this study) makes it difficult to distinguish between real infection and simple colonization. In addition, the impact of early implementation of appropriate therapy on the evolution of infectious disease (mortality, morbidity, etc.) has been clearly demonstrated for serious infections such as bacteremia and respiratory infections, while this impact remains more limited or even insignificant for urinary infections. Hence the desire to exclude isolated strains of urine samples.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (5)

• Castanheira M, Duncan LR, Mendes RE, Sader HS, Shortridge D. Activity of Ceftolozane-Tazobactam against Pseudomonas aeruginosa and Enterobacteriaceae Isolates Collected from Respiratory Tract Specimens of Hospitalized Patients in the United States during 2013 to 2015. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e02125-17. doi: 10.1128/AAC.02125-17. Print 2018 Mar.

  PMID: 29263073 RESULT

• Walkty A, Adam H, Baxter M, Lagace-Wiens P, Karlowsky JA, Hoban DJ, Zhanel GG. In vitro activity of ceftolozane/tazobactam versus antimicrobial non-susceptible Pseudomonas aeruginosa clinical isolates including MDR and XDR isolates obtained from across Canada as part of the CANWARD study, 2008-16. J Antimicrob Chemother. 2018 Mar 1;73(3):703-708. doi: 10.1093/jac/dkx468.

  PMID: 29244121 RESULT

• Monogue ML, Nicolau DP. Antibacterial activity of ceftolozane/tazobactam alone and in combination with other antimicrobial agents against MDR Pseudomonas aeruginosa. J Antimicrob Chemother. 2018 Apr 1;73(4):942-952. doi: 10.1093/jac/dkx483.

  PMID: 29272436 RESULT

• Munita JM, Aitken SL, Miller WR, Perez F, Rosa R, Shimose LA, Lichtenberger PN, Abbo LM, Jain R, Nigo M, Wanger A, Araos R, Tran TT, Adachi J, Rakita R, Shelburne S, Bonomo RA, Arias CA. Multicenter Evaluation of Ceftolozane/Tazobactam for Serious Infections Caused by Carbapenem-Resistant Pseudomonas aeruginosa. Clin Infect Dis. 2017 Jul 1;65(1):158-161. doi: 10.1093/cid/cix014.

  PMID: 28329350 RESULT

• Chen M, Zhang M, Huang P, Lin Q, Sun C, Zeng H, Deng Y. Novel beta-lactam/beta-lactamase inhibitors versus alternative antibiotics for the treatment of complicated intra-abdominal infection and complicated urinary tract infection: a meta-analysis of randomized controlled trials. Expert Rev Anti Infect Ther. 2018 Feb;16(2):111-120. doi: 10.1080/14787210.2018.1429912. Epub 2018 Jan 24.

  PMID: 29343141 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

For hospitalized patients who may have a community or nosocomial Gram-negative bacillus infection of the enterobacterial type or P. aeruginosa type, diagnostic specimens are taken by the clinical department and sent to the local microbiology laboratory for investigation, in accordance with standard management. Depending on the location, the samples may be AMLs (Bronchial-Alveolar Washing), PDPs (Protected Distal Sampling), blood culture, ascites, operating room samples or other puncture.

Study Officials

• Alban Le Monnier, Professor

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 24, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: December 30, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)