NCT06044272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

July 20, 2023

Last Update Submit

December 9, 2024

Conditions

Keywords

Patient SafetyHealthcare Quality AssuranceCross InfectionIncreased Drug ResistanceColombia

Outcome Measures

Primary Outcomes (1)

  • Number of microorganisms resistant to the antimicrobial

    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

Study Arms (5)

Escherichia coli producing ESBL

Ceftazidime or cefotaxime resistance.

Other: Factors associated

Klebsiella pneumoniae producing ESBL

Ceftazidime or cefotaxime resistance.

Other: Factors associated

Klebsiella pneumoniae resistant to carbapenem

Ertapenem resistance.

Other: Factors associated

Pseudomonas aeruginosa resistant to carbapenems

Imipenem or meropenem resistance.

Other: Factors associated

Staphylococcus aureus resistant to methicillin

Methicillin resistance.

Other: Factors associated

Interventions

Factors associated with the type of resistance by microorganisms.

Escherichia coli producing ESBLKlebsiella pneumoniae producing ESBLKlebsiella pneumoniae resistant to carbapenemPseudomonas aeruginosa resistant to carbapenemsStaphylococcus aureus resistant to methicillin

Eligibility Criteria

AgeUp to 130 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, 50001, Colombia

Location

Related Publications (20)

  • Kawata S, Morimoto S, Kosai K, Kawamoto Y, Nakashima Y, Morinaga Y, Yanagihara K, Yoshida LM, Moriuchi H. The fecal carriage rate of extended-spectrum beta-lactamase-producing or carbapenem-resistant Enterobacterales among Japanese infants in the community at the 4-month health examination in a rural city. Front Cell Infect Microbiol. 2023 Jun 14;13:1168451. doi: 10.3389/fcimb.2023.1168451. eCollection 2023.

  • Zhou Y, Zhou S, Peng J, Min L, Chen Q, Ke J. Bacterial distribution and drug resistance in blood samples of children in Jiangxi Region, 2017-2021. Front Cell Infect Microbiol. 2023 Jun 22;13:1163312. doi: 10.3389/fcimb.2023.1163312. eCollection 2023.

  • Quiros RE, Bardossy AC, Angeleri P, Zurita J, Aleman Espinoza WR, Carneiro M, Guerra S, Medina J, Castaneda Luquerna X, Guerra A, Vega S, Cuellar Ponce de Leon LE, Munita J, Escobar ED, Maki G, Prentiss T, Zervos M; PROA-LATAM Project Group. Antimicrobial stewardship programs in adult intensive care units in Latin America: Implementation, assessments, and impact on outcomes. Infect Control Hosp Epidemiol. 2022 Feb;43(2):181-190. doi: 10.1017/ice.2021.80. Epub 2021 Apr 8.

  • Sharma A, Luvsansharav UO, Paul P, Lutgring JD, Call DR, Omulo S, Laserson K, Araos R, Munita JM, Verani J, Chowdhury F, Muneer SM, Espinosa-Bode A, Ramay B, Cordon-Rosales C, Kumar CPG, Bhatnagar T, Gupta N, Park B, Smith RM. Multi-country cross-sectional study of colonization with multidrug-resistant organisms: protocol and methods for the Antibiotic Resistance in Communities and Hospitals (ARCH) studies. BMC Public Health. 2021 Jul 16;21(1):1412. doi: 10.1186/s12889-021-11451-y.

  • Alzamora MC, Echevarria AC, Ferraro VM, Riveros MD, Zambruni M, Ochoa TJ. [Antimicrobial resistance of commensal Escherichia coli strains in children of two rural communities in Peru]. Rev Peru Med Exp Salud Publica. 2019 Jul-Sep;36(3):459-463. doi: 10.17843/rpmesp.2019.363.4366. Epub 2019 Dec 2. Spanish.

  • Revoredo Rego F, Huaman Egoavil E, Zegarra Cavani S, Auris Mora H, Valderrama Barrientos R. [Microbiological and resistance profiles of community acquired and nosocomial intra abdominal infections in surgery of National Hospital Guillermo Almenara, Lima, Peru]. Rev Gastroenterol Peru. 2016 Apr-Jun;36(2):115-22. Spanish.

  • Vallejo M, Cuesta DP, Florez LE, Correa A, Llanos CE, Isaza B, Vanegas S, Osorio J, Casanova L, Villegas MV. [Clinical and microbiological characteristics of complicated intra-abdominal infection in Colombia: a multicenter study]. Rev Chilena Infectol. 2016 Jun;33(3):261-7. doi: 10.4067/S0716-10182016000300002. Spanish.

  • Arias-Flores R, Rosado-Quiab U, Vargas-Valerio A, Grajales-Muniz C. [Microorganisms responsible of nosocomial infections in the Mexican Social Security Institute]. Rev Med Inst Mex Seguro Soc. 2016 Jan-Feb;54(1):20-4. Spanish.

  • Mata-Hernandez A, Rivera-Villa AH, Miguel-Perez A, Perez-Atanasio JM, Torres-Gonzalez R. [Sensitivity and antibiotic resistance in infections of the musculoskeletal system]. Rev Med Inst Mex Seguro Soc. 2016;54 Suppl 3:S320-S324. Spanish.

  • Morganti L, Cordova E, Cassini E, Gomez N, Lopez Moral L, Badia M, Rodriguez C. [Antimicrobial susceptibility of Gram-negative bacilli of community acquired intra-abdominal infections in a hospital at Buenos Aires, Argentina]. Rev Esp Quimioter. 2016 Aug;29(4):202-5. Epub 2016 Jun 17. Spanish.

  • Ruiz-Garbajosa P, Canton R. [Epidemiology of multi-drug resistant gramnegative bacilli]. Rev Esp Quimioter. 2016 Sep;29 Suppl 1:21-5. Spanish.

  • De La Rosa G, Leon AL, Jaimes F. [Epidemiology and prognosis of patients with bloodstream infection in 10 hospitals in Colombia]. Rev Chilena Infectol. 2016 Apr;33(2):141-9. doi: 10.4067/S0716-10182016000200003. Spanish.

  • Salgado P, Gilsanz F, Maseda E. [Resistant gram-negative bacteria. Therapeutic approach and risk factors]. Rev Esp Quimioter. 2016 Sep;29 Suppl 1:26-30. Spanish.

  • Moya-Dionisio V, Diaz-Zabala M, Ibanez-Fernandez A, Suarez-Leiva P, Martinez-Suarez V, Ordonez-Alvarez FA, Santos-Rodriguez F. [Uropathogen pattern and antimicrobial susceptibility in positive urinary cultures isolates from paediatric patients]. Rev Esp Quimioter. 2016 Jun;29(3):146-50. Epub 2016 Apr 19. Spanish.

  • Cercenado E. [Epidemiology of the infection by resistant Gram-positive microorganisms]. Rev Esp Quimioter. 2016 Sep;29 Suppl 1:6-9. Spanish.

  • Cercenado E. [Laboratory detection of carbapenemase-producing Enterobacteriaceae]. Rev Esp Quimioter. 2015 Sep;28 Suppl 1:8-11. Spanish.

  • Betran A, Cortes AM, Lopez C. [Evaluation of antibiotic resistance of Escherichia coli in urinary tract infections in Primary Care Barbastro Sector (Huesca)]. Rev Esp Quimioter. 2015 Oct;28(5):263-6. Spanish.

  • 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.

    RESULT
  • Ocampo AM, Vargas CA, Sierra PM, Cienfuegos AV, Jimenez JN. [Molecular characterization of an outbreak of carbapenem-resistant Klebsiella pneumoniae in a tertiary care hospital in Medellin, Colombia]. Biomedica. 2015 Oct-Dec;35(4):496-504. doi: 10.7705/biomedica.v35i4.2610. Spanish.

  • 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.

    RESULT

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Norton Perez, MD

    Cooperative University of Colombia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 20, 2023

First Posted

September 21, 2023

Study Start

September 1, 2023

Primary Completion

November 30, 2023

Study Completion

June 30, 2024

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

The database is access restricted in the university repository.

Locations