Antimicrobial Resistance in Hospitals From Meta, Colombia

September 16, 2023 updated by: Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
    • Meta
      • Villavicencio, Meta, Colombia, 50001
        • Hospital Departamental de Villavicencio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Escherichia coli producing ESBL
Ceftazidime or cefotaxime resistance.
Other: Factors associated
Factors associated with the type of resistance by microorganisms.
Klebsiella pneumoniae producing ESBL
Ceftazidime or cefotaxime resistance.
Other: Factors associated
Factors associated with the type of resistance by microorganisms.
Klebsiella pneumoniae resistant to carbapenem
Ertapenem resistance.
Other: Factors associated
Factors associated with the type of resistance by microorganisms.
Pseudomonas aeruginosa resistant to carbapenems
Imipenem or meropenem resistance.
Other: Factors associated
Factors associated with the type of resistance by microorganisms.
Staphylococcus aureus resistant to methicillin
Methicillin resistance.
Other: Factors associated
Factors associated with the type of resistance by microorganisms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Departamental de Villavicencio

Collaborators

Cooperative University of Colombia

Investigators

  • Principal Investigator: Norton Perez, MD, Cooperative University of Colombia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

September 16, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GRIVI_2023_03_RAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The database is access restricted in the university repository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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