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Completed

NCT Number: NCT06044272

Antimicrobial Resistance in Hospitals From Meta, Colombia

Introduction: Healthcare-associated infections cause a burden in morbidity and mortality, and they increase the financial cost of care. Nevertheless, they are not limited to setting factors, and several community conditions and contexts are linked. Clinical laboratories from hospitals report monthly to the Public Health Laboratory.

Objective: The study aims to establish the antimicrobial resistance profile of the most significant bacteria involved in healthcare-associated infections in Meta State hospitals.

Methodology: The researchers designed a retrospective observational trial with the records from samples and origin, microbial findings, and antibiogram. The outcome was the mechanism for antimicrobial resistance. The information from the State Public Health Laboratory database was exported to Excel for analysis.

Conclusions: The outlook of Enterobacteriaceae and Staphylococcus aureus antimicrobial resistance in hospitals from Meta State will be revealed. Comprehensive strategies for mitigation, including continuous microbiological surveillance, are needed.

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Key information

Age range

Up to 130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, 50001, Colombia

About this study

Healthcare-associated infections (HCAIs) affect patients' security and quality of care. Several of them develop infections during their hospital stay, especially in the ICU, and the number is higher in low-middle-income countries. It confers an additional burden on hospitals, with higher use of resources and costs. The magnitude of the problem is not understood completely due to discrepancies in results and heterogeneous studies.

Additionally, HCAIs are associated with increased morbidity and disability, but the studies are unsure of the effect on mortality.

Microorganisms are ubiquitous in hospital environments and diverse in patients, families, and healthcare personnel. Some are carriers of antimicrobial resistance mechanisms (AMR) and are transmissible to other microorganisms. Studies with genetic sequencing show a fundamental role of such colonization as a reservoir for AMR that limits the efficacy of therapy since admission. Such technology is not available to most hospitals to screen environments or people. Such interaction favors an interchange of microbiome (directly or indirectly) as a requirement for the advent of HCAIs.

It is known that HCAIs by MDR (multidrug resistance) bacteria are associated with an increase in mortality (OR 1.61; 1.36-1.90); it is not clear if it is due to the problem in the quality of care or the health conditions that promotes the infection.

The frequency of HCAIs is higher in Latin America than in the United States or Europe. The Centers for Disease Control and Prevention regularly monitor DAI (device-associated infections) from several years ago, and they are of reference worldwide.

Some countries have developed microbiological surveillance systems to follow up on changes in resistance phenotypes. They reveal benign resistance patterns in Gram-negative in contrast to the reports from studies in Colombia. Such results highlight the importance of analyzing the information provided by such monitoring to prioritize actions and resources to modulate the impact of the increased resistance.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All records with results from microbial isolation and antimicrobial resistance profile.

Exclusion criteria

  • Records of quality control; no information on resistance or susceptibility.

Treatment and study plan

Factors associated

Other

Factors associated with the type of resistance by microorganisms.

Primary outcomes

  1. Number of microorganisms resistant to the antimicrobial

    Time frame: 28 days

    Mechanism of resistance by type of microorganisms. ESBL in E. coli and K. pneumoniae, carbapenemase in K.pneumoniae and Pseudomonas, and methicilinase in S. aureus.

Sponsors and collaborators

Lead sponsor

Hospital Departamental de Villavicencio

Other

Collaborators

  • Cooperative University of Colombia

Registry information

Official study title

Antimicrobial Resistance Profiles in Healthcare Facilities From Meta State, Colombia: A Retrospective Observational Study From 2018-2022

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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