Antimicrobial Resistance in Hospitals From Meta, Colombia

Completed

• Conditions: Increased Drug Resistance
• Interventions: Other: Factors associated

• Registration Number: NCT06044272
• Lead Sponsor: Hospital Departamental de Villavicencio

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.

Study Timeline

• Study First Submitted: 2023-07-20
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-09-16
• Study First Posted: 2023-09-21
• Primary Completion: 2023-11-30
• Study Completion: 2024-06-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Klebsiella pneumoniae resistant to carbapenem	Factors associated	Ertapenem resistance.
Klebsiella pneumoniae producing ESBL	Factors associated	Ceftazidime or cefotaxime resistance.
Pseudomonas aeruginosa resistant to carbapenems	Factors associated	Imipenem or meropenem resistance.
Staphylococcus aureus resistant to methicillin	Factors associated	Methicillin resistance.
Escherichia coli producing ESBL	Factors associated	Ceftazidime or cefotaxime resistance.

Primary Outcome Measures

Name	Time	Method
Number of microorganisms resistant to the antimicrobial	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.

Trial Locations

Locations (1)

Hospital Departamental de Villavicencio; 🇨🇴 Villavicencio, Meta, Colombia