Active Surveillance Cultures for Multidrug Resistant Gram-Negative Organisms at an Acute Care Hospital

NCT04715464 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2878

Last updated 2026-03-24

No results posted yet for this study

Summary

Active Surveillance Culture programs (ASC) have been initiated in health-care systems in recent years as a mechanism for tracking multi-drug resistant organisms (MDRO), with a goal to reduce the transfer of those organisms to other patients. Consequently, the Center for Disease Prevention and Control (CDC) charged infection control personnel to develop institutional guidelines for the prevention of transmission of multidrug-resistant organisms, within health care settings. The CDC guidelines include performance of active surveillance cultures for patients after admission to health care facilities or to high-risk-patient care units, to detect colonization with target multidrug-resistant organisms. The most commonly tracked antimicrobial resistance organisms in hospital surveillance programs are methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant enterococcus (VRE), Clostridium difficile, extended-spectrum beta-lactamase (ESBL) producing gram-negative bacilli (e.g. Escherichia coli, Klebsiella pneumoniae), and carbapenem resistant Enterobacteriaceae (CRE). Patients who are colonized with these potential pathogens are placed under contact precautions to prevent transmission to other patients. While clinical outcomes studies exist for MDR gram-positive organisms \[particularly methicillin resistant Staphylococcus aureus (MRSA)\] ASC, data is limited for MDR gram-negative organisms. The study is retrospective cohort study to evaluate if isolation of an MDR gram-negative pathogen on ASC predicts subsequent infection with the same pathogen.

Patients \>18 years of age, admitted to MHS with ASC for MDR gram-negative pathogens, will be included if criteria met. Outcomes of interest will be evaluated with appropriate statistical tests, and multivariate analyses will be used to control for predictors of interest. All analysis will be considered significant at an alpha of \<0.05. The investigators anticipate that increased screening with isolation will result in decreased subsequent MDRO gram-negative infection. Furthermore, the investigators hope that this will also result in improved patient's outcomes, mortality, and decreased cost, including excessive use of anti-infectives and its unintended consequences such as microbial resistance.

Conditions

Interventions

OTHER

review of surveillance cultures within the past year

ASC results are reported as positive or negative based on the culture source. Antimicrobial susceptibility testing is performed but not reported; however, physicians may obtain susceptibility information for MDR GNB only if clinically indicated through the microbiology department. 1. Nasal swab for MRSA 2. Respiratory specimens i. Sputum for MRSA, VRE, and Multi Drug Resistant gram-negative Bacteria (MDR GNB) (if not intubated but with productive cough) ii. Endotracheal aspirate for MRSA, VRE, and MDR GNB (if intubated) c. Drainage from any wounds for MRSA, VRE, and MDR GNB d. Rectal/ perianal swab for VRE, and MDR GNB e. Urine for MRSA, VRE, and MDR GNB (from patients catheterized prior to admission only)

Sponsors & Collaborators

  • Methodist Health System

    lead OTHER

Principal Investigators

  • Rhonda Akins, PharmD · Methodist Health System

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-12
Primary Completion
2020-03-31
Completion
2020-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04715464 on ClinicalTrials.gov