InfectionNCT04715464
Active Surveillance Cultures for Multidrug Resistant Gram-Negative Organisms at an Acute Care Hospital
An observational study of Infection, run by Methodist Health System.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- review of surveillance cultures within the past year
- How many people
- 2,878 participants
- Where
- No sites listed yet
- Study dates
- 12 Feb 2015to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any inpatient, except patients admitted through Labor \& Delivery departments at Methodist Charlton Medical Center
Who may be able to join
- 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.
Who cannot join
- NA
About this study
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.
Read the detailed description
This is a retrospective cross-sectional study of patients with ASC at MHS. Patients >18 years of age, admitted to MHS during the study specified period, will be included if there is documented ASC. Patients will be identified through the clinical microbiology laboratory records. Figure 1 is a flow diagram of ASC stratification.
Study populations All patients with documented laboratory surveillance culture from January 1, 2006 to December 31, 2012 will be included. Eligible cultures (see definitions below) will be identified based on positive surveillance cultures from MHS. Patients identified with select criteria per objective will be further analyzed in subsequent phases to complete all outcomes of interest. Patients will be excluded if they are ≤18 years, expired before initial surveillance culture is positive, were not admitted, or were transferred to another institution. Patients will be excluded if they underwent amputation or surgical revision for wound infections. Patients with polymicrobial MDR gram-negative pathogen on ASC will be included; however, the main focus of this study is the subset of patients with monomicrobial ASC. Lastly, only the index culture will be considered, for patients with multiple wounds ASC.
Data Collection Initial phase will focus on review of surveillance cultures within the past year (calendar year 2012) to determine objective number one. Prior years are included to evaluate earlier documentation of colonization and whether number of patients/cultures per year has significant variation. Subsequent phases will collect specific data identified as significant or varied based on previous analysis. Data will be collected via extraction and chart review from MHS's electronic medical record (EMR) on identified patients.
Patient demographics (weight, sex, race, age, allergy), co-morbid conditions (diabetes, immunosuppressed, HIV/AIDS, organ transplant, malignancy, chronic lung disease, chronic kidney disease, liver disease, surgery in past 30 days), location in the hospital, type of residence (i.e., home, long-term care facility, etc), source of infection, treatment data (antibiotics administered and duration), length of stay in survivors, hospital cost, antibiotic cost, severity of illness by mean Simplified Acute Physiologic Score (SAPS) II score (based on clinical data present during the 24 hours preceding the index blood culture), hospital mortality, and DRG. Previous hospitalizations, antimicrobial usage and surveillance culture results will be recorded.
Surveillance cultures from nares, rectum, endotracheal aspirates, urine, and wound swab will be included. Microbiology data (organism, culture source, and number of classes of antibiotics with resistance) will be documented. Patients with positive ASC for MDR gram-negative pathogens will be evaluated for antimicrobial use for 1) ASC only and 2) Subsequent positive cultures due to suspected or proven active infection. Cost for each of the following classifications will be determined and compared: microbiological cultures including antimicrobial susceptibility test, length of stay, cost of antimicrobial and associated diagnosis related groups (DRG) per infection type.
- Conditions
- Infection
- Being tested
- review of surveillance cultures within the past year
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
review of surveillance cultures within the past yearOther
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.
- Nasal swab for MRSA
- Respiratory specimens
- 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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive ASC with an MDR gram-negative pathogen is a predictor of subsequent active infection
development of infection during hospital stay (days)
Measured: January 1, 2006 to December 31, 2012
Secondary outcomes (1)
The extent of antimicrobial treatment secondary to positive ASC
The relationship between antimicrobial usage and increased resistance will decide the cost of treatment (dollars)
Measured: January 1, 2006 to December 31, 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start12 Feb 2015
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rhonda Akins, PharmD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715464
- Sponsor's protocol ID
- 023.PHA.2015.C
- Status last verified
- Jul 2024
- First submitted
- 3 Apr 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance Cultures for Multidrug Resistant Gram-Negative Organisms at an Acute Care Hospital
- ClinicalTrials.gov ID
- NCT04715464
- Acronym / sponsor ID
- 023.PHA.2015.C
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,878 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 12 Feb 2015 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective cross-sectional study of patients with ASC at MHS. Patients >18 years of age, admitted to MHS during the study specified period, will be included if there is documented ASC. Patients will be identified through the clinical microbiology laboratory records. Figure 1 is a flow diagram of ASC stratification.
Study populations All patients with documented laboratory surveillance culture from January 1, 2006 to December 31, 2012 will be included. Eligible cultures (see definitions below) will be identified based on positive surveillance cultures from MHS. Patients identified with select criteria per objective will be further analyzed in subsequent phases to complete all outcomes of interest. Patients will be excluded if they are ≤18 years, expired before initial surveillance culture is positive, were not admitted, or were transferred to another institution. Patients will be excluded if they underwent amputation or surgical revision for wound infections. Patients with polymicrobial MDR gram-negative pathogen on ASC will be included; however, the main focus of this study is the subset of patients with monomicrobial ASC. Lastly, only the index culture will be considered, for patients with multiple wounds ASC.
Data Collection Initial phase will focus on review of surveillance cultures within the past year (calendar year 2012) to determine objective number one. Prior years are included to evaluate earlier documentation of colonization and whether number of patients/cultures per year has significant variation. Subsequent phases will collect specific data identified as significant or varied based on previous analysis. Data will be collected via extraction and chart review from MHS's electronic medical record (EMR) on identified patients.
Patient demographics (weight, sex, race, age, allergy), co-morbid conditions (diabetes, immunosuppressed, HIV/AIDS, organ transplant, malignancy, chronic lung disease, chronic kidney disease, liver disease, surgery in past 30 days), location in the hospital, type of residence (i.e., home, long-term care facility, etc), source of infection, treatment data (antibiotics administered and duration), length of stay in survivors, hospital cost, antibiotic cost, severity of illness by mean Simplified Acute Physiologic Score (SAPS) II score (based on clinical data present during the 24 hours preceding the index blood culture), hospital mortality, and DRG. Previous hospitalizations, antimicrobial usage and surveillance culture results will be recorded.
Surveillance cultures from nares, rectum, endotracheal aspirates, urine, and wound swab will be included. Microbiology data (organism, culture source, and number of classes of antibiotics with resistance) will be documented. Patients with positive ASC for MDR gram-negative pathogens will be evaluated for antimicrobial use for 1) ASC only and 2) Subsequent positive cultures due to suspected or proven active infection. Cost for each of the following classifications will be determined and compared: microbiological cultures including antimicrobial susceptibility test, length of stay, cost of antimicrobial and associated diagnosis related groups (DRG) per infection type.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any inpatient, except patients admitted through Labor \& Delivery departments at Methodist Charlton Medical Center
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| review of surveillance cultures within the past yearASC 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) | Other | – |
Primary outcome
Positive ASC with an MDR gram-negative pathogen is a predictor of subsequent active infection
Time frame: January 1, 2006 to December 31, 2012
development of infection during hospital stay (days)
1 secondary outcome
The extent of antimicrobial treatment secondary to positive ASC
Time frame: January 1, 2006 to December 31, 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhonda Akins, PharmD principal investigator
Methodist Health System
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Methodist Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive ASC with an MDR gram-negative pathogen is a predictor of subsequent active infection (time frame: January 1, 2006 to December 31, 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.