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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06044272
Other study ID # GRIVI_2023_03_RAM
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2023
Est. completion date June 2024

Study information

Verified date September 2023
Source Hospital Departamental de Villavicencio
Contact Norton Perez, MD
Phone 3112517471
Email norton.perez@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10000
Est. completion date June 2024
Est. primary completion date November 2023
Accepts healthy volunteers
Gender All
Age group N/A to 130 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Factors associated
Factors associated with the type of resistance by microorganisms.

Locations

Country Name City State
Colombia Hospital Departamental de Villavicencio Villavicencio Meta

Sponsors (2)

Lead Sponsor Collaborator
Hospital Departamental de Villavicencio Cooperative University of Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (20)

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: 10.17 — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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.

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 communit — View Citation

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. — View Citation

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; — View Citation

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 Q — View Citation

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/bi — View Citation

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.

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 — View Citation

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, — View Citation

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

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. — View Citation

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-sectiona — View Citation

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. 20 — View Citation

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. — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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