Clinical trial NCT06044272: Antimicrobial Resistance in Hospitals From Meta, Colombia
Official title: Antimicrobial Resistance Profiles in Healthcare Facilities From Meta State, Colombia: A Retrospective Observational Study From 2018-2022
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Increased Drug Resistance
Keywords: Patient Safety
Healthcare Quality Assurance
Cross Infection
Increased Drug Resistance
Colombia
Lead sponsor: Hospital Departamental de Villavicencio
Sponsor class: OTHER
Collaborators: name: Cooperative University of Colombia
First posted: 2023-09-21
Enrollment: 10000
Sex: ALL
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population included in the study were the records of microbiological isolation for surveillance from the Public Health Laboratory of Meta State Secretary of Health.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of microorganisms resistant to the antimicrobial
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Villavicencio
country: Colombia
facility: Hospital Departamental de Villavicencio
state: Meta
Study officials:
affiliation: Cooperative University of Colombia
name: Norton Perez, MD
role: PRINCIPAL_INVESTIGATOR
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