Clinical and Biological Impact of Gut Microbiota in Adult Patients With Bacteremia During the COVID-19 Pandemic

NCT07183722 | Active Not Recruiting

• 1 other identifier: ASO.Microb.22.01
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The widespread use of antibiotics in healthcare, veterinary, and agricultural sectors has significantly contributed to the rise of antimicrobial resistance (AMR), affecting both commensal and pathogenic microorganisms. AMR infections are linked to poorer patient outcomes, prolonged hospital stays, and increased mortality. The COVID-19 pandemic exacerbated this issue through the overuse of antibiotics in hospitalized patients, worsening global resistance trends. Six bacterial species-Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.-are considered urgent targets for new drug development. Advanced diagnostic methods, particularly Next Generation Sequencing (NGS), show promise in improving the detection and management of sepsis and resistant infections. However, effective application of NGS requires interdisciplinary collaboration and specialized expertise, highlighting the need for integrated efforts between research institutions and clinical centers to improve AMR surveillance, diagnostics, and treatment strategies.

Conditions

Microbiota

Outcome Measures

Primary Outcomes (1)

• Microbiota Analysis

  Studying the gut microbiota of patients colonized/infected with multidrug-resistant microorganisms to assess the potential role of protective factors against colonization and bacteremia caused by these microorganisms.

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Analysis of genetic variants

  Through study completion, an average of 1 year

• Phylogenetic correlation of genomic resistance profiles

  Through study completion, an average of 1 year

• Antibiotic susceptibility

  Through study completion, an average of 1 year

• Identify the optimal model for rapid diagnosis

  Through study completion, an average of 1 year

Interventions

Microbiota analysis OTHER

Analysis of microbiota in patients admitted to the following departments: General Anesthesia and Resuscitation, Cardio-Thoracic-Vascular Anesthesia and Resuscitation, Internal Medicine, and MeCAU.

Eligibility Criteria

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

Study Population

Patients admitted to the following departments: General Anesthesia and Resuscitation, Cardio-Thoracic-Vascular Anesthesia and Resuscitation, Internal Medicine, and MeCAU.

You may qualify if:

• Age ≥ 18 years;
• Patients admitted to the following departments: General Anesthesia and Resuscitation, Cardio-Thoracic-Vascular Anesthesia and Resuscitation, Internal Medicine, and MeCAU
• Signature of informed consent to participate in the study.

You may not qualify if:

• Absence of informed consent signature

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

SSD Laboratori di Ricerca (DAIRI) - AOU Alessandria

Alessandria, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

rectal swab, nasopharyngeal swab, and peripheral blood sample

Study Design

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

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 19, 2025
• Study Start: October 4, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)