Phenotypic Profile and Molecular Mechanism of Resistance in Carbapenemase-producing Enterobacterales and Pseudomonas Aeruginosa Isolates From Brazilian Hospitals: Implications for the Introduction of IMIPENEM-RELEBACTAM

NCT05285046 | Unknown

• 1 other identifier: 15054519.3.0000.5249B
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The global dissemination of carbapenem-resistant Enterobacteriaceae (CRE) and Pseudomonas aeruginosa (CRPA) are a significant threat to health care, especially for severely ill patients. Antibiotics currently used to treat CRE and CRPA infections are usually toxic and not very effective. Novel treatments include beta-lactamase inhibitors with broad-spectrum activity, among them IMI-REL. IMI-REL is a promising molecule due to the ability of REL to diminish carbapenem MICs to the susceptible range, potentially restoring the activity of this potent drug. However, few studies have systematically examined IMI-REL activity against a diverse clinical collection of CRE and CRPA strains, in particular from a region where the resistance is high, and the main mechanisms are in general unknown (Brazil- Latin America). As the use of molecular diagnostics becomes increasingly available in clinical settings, it is crucial to identify molecular markers predicting antimicrobial efficacy to guide therapeutic decision-making. In the present study, we will acess different species of CRE and CRPA from clinically relevant isolates to determine if the species, clonal lineage, and resistance gene profile, have influence to the response to IMI-REL.

Conditions

Bacterial Infections; Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (1)

• Susceptibility profile of imipenem-relebactam

  Evaluation of the susceptibility profile of imipenem-relebactam in isolates possessing the Class A and D carbapenemase gene.

  immediately after the analysis.

Interventions

No intervention OTHER

No intervention

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

We will evaluate prospectively 150 (one hundred and fifty) Enterobacterales and 100 (one hundred) Pseudomonas aeruginosa isolates from 12 hospitals in Rio de Janeiro.

You may qualify if:

• Microbiologics analysis indicating carbapenem resistance

You may not qualify if:

• Microbiologics analysis indicating Negative class A and D cabapenemase gene

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead

Study Sites (1)

D'Or Institute for Research and Education (IDOR)

Rio de Janeiro, 22281-100, Brazil

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Fernando Bozza, PhD

  D'Or Institute for Research and Education (IDOR)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 17, 2022
• Study Start: April 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: February 28, 2023
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

BR (1)