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

NCT04715464 | Completed

• 1 other identifier: 023.PHA.2015.C
• Study Type: observational
• Target: 2,878
• Locations: 0 countries
• Sites: N/A

Brief 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

Infection

Outcome Measures

Primary Outcomes (1)

• Positive ASC with an MDR gram-negative pathogen is a predictor of subsequent active infection

  development of infection during hospital stay (days)

  January 1, 2006 to December 31, 2012

Secondary Outcomes (1)

• The extent of antimicrobial treatment secondary to positive ASC

  January 1, 2006 to December 31, 2012

Interventions

review of surveillance cultures within the past year OTHER

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any inpatient, except patients admitted through Labor \& Delivery departments at Methodist Charlton Medical Center

You may qualify if:

• Any inpatient, except patients admitted through Labor \& Delivery departments, meeting the following criteria will be cultured
• Patient has one of the following risk factors for MDROs:
• Hospitalization for 2 consecutive nights or more in the preceding 30 days
• Residence in a nursing home or extended/long term care facility
• Presence of decubitus ulcer or a draining wound
• Admission assessment in the Emergency Department and on nursing units includes questions regarding past history of Multi Drug Resistant (MDR) infection or colonization.

Sponsors & Collaborators

• Methodist Health System: lead

MeSH Terms

Conditions

Infections

Study Officials

• Rhonda Akins, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: January 20, 2021
• Study Start: February 12, 2015
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 24, 2026

Record last verified: 2024-07