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Antimicrobial Resistance in Hospitals From Meta, Colombia

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ClinicalTrials.gov Identifier: NCT06044272
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborator:
Cooperative University of Colombia
Information provided by (Responsible Party):
Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

Study Description
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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.


Condition or disease Intervention/treatment
Increased Drug Resistance Other: Factors associated

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 Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Antimicrobial Resistance Profiles in Healthcare Facilities From Meta State, Colombia: A Retrospective Observational Study From 2018-2022
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   up to 130 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044272


Contacts
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Contact: Norton Perez, MD 3112517471 norton.perez@hotmail.com
Contact: Emma I Rodriguez, MSc 3112517538 emmaisa1@hotmail.com

Locations
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Colombia
Hospital Departamental de Villavicencio
Villavicencio, Meta, Colombia, 50001
Sponsors and Collaborators
Hospital Departamental de Villavicencio
Cooperative University of Colombia
Investigators
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Principal Investigator: Norton Perez, MD Cooperative University of Colombia
More Information
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Publications of Results:
Gutiérrez Lesmes OA. [Resistance and susceptibility of microorganisms isolatedin patients treated in a tertiary institution hospital, Villavicencio-Colombia, 2012]. Rev Cuid. 2015 May 15;6(1):947-54.
Pérez N, Pavas N, Rodríguez EI. Resistencia a los antibióticos en Escherichia coli con beta-lactamasas de espectro extendido en un hospital de la Orinoquia colombiana. Infectio. 2011;15(3):147-54.

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Responsible Party: Norton Perez-Gutierrez, MD, Principal investigator, Hospital Departamental de Villavicencio
ClinicalTrials.gov Identifier: NCT06044272    
Other Study ID Numbers: GRIVI_2023_03_RAM
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The database is access restricted in the university repository.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio:
Patient Safety
Healthcare Quality Assurance
Cross Infection
Increased Drug Resistance
Colombia