Multi-Drug Resistant Organism Network - MDRO Network
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 6,496
- Locations
- 4
- Primary Endpoint
- Source of positive culture
Study Overview
Brief Summary
This study is specifically designed to provide observational data which can be used to help in the design of future randomized clinical trials on both therapeutics and diagnostics for MDRO infections. To this end, clinical and epidemiological data will be collected on patients who have MDRO isolated from clinical cultures during hospitalization, as well as descriptions of the outcomes of patients treated with various antimicrobial regimens. Molecular and microbiological characterization will also be performed on MDRO isolates. These data will include a detailed clinical and epidemiological description of patients including identifying potential barriers to enrollment in future trials. In addition, data will be collected on species, strain type, and mechanism of drug resistance of the causative organism. Knowing the molecular characteristics will further inform future trial design as not all diagnostics detect and not all therapeutics are active against the same mechanisms of resistance.
Detailed Description
This is a prospective multi-center study. At each hospital, study personnel will screen the microbiology laboratory logs to identify all patients found to have a MDRO isolate from one or more anatomical sites during hospitalization. For each patient identified, designated site personnel will access the patient's medical record and use web-based data entry to enter the relevant data into the electronic case report form (eCRF) in the study's centralized database.
A sample of all MDRO isolates (bacterial isolates) will be sent to a central research laboratory for molecular analysis which will include strain typing. In addition, the mechanism of resistance will be determined by performing PCR and/or Whole Genome Sequencing.
Aim 1. Identification of target population and high volume centers. The prevalence of specific MDRO is extremely variable in various patient populations. In addition, over time, prevalence patterns for specific MDRO tend to change. The data collection carried out under this protocol will provide real-time data on which patients are the target population for any trial directed against MDRO infection. Also, the data collected will indicate which geographic areas and which centers have the highest incidence of MDRO infections. This will facilitate rational site selection for future trials.
Aim 2. Provide data on impact of potential inclusion/exclusion criteria on enrollment in future trials.
Detailed clinical data will be collected to guide the future development of clinical trials. The eCRF is designed to collect data on the most common barriers to enrollment in clinical trials. Data can then be used in the design of future trials to be presented to pharmaceutical companies, as well as to regulators from the FDA, to provide a rationale for requesting exceptions in inclusion/exclusion criteria. This will result in clinical trials that are more readily generalizable.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospitalized patients.
- •Must have at least one multi-drug resistant organism isolated from a clinical culture while hospitalized.
Exclusion Criteria
- •Patients who do not have a positive culture during hospitalization.
- •Patients who's only positive culture was obtained outside of hospital admission.
- •Patients who have cystic fibrosis and a CRPa infection.
Outcomes
Primary Outcomes
Source of positive culture
Time Frame: At collection of the MDRO isolates
The differences in outcomes based on the anatomic source of the positive culture are determined. The anatomic sources collected are blood, respiratory, urine, wound, abdominal, and other, which is collected from the medical record.
Length of Stay
Time Frame: Up to 1 year from index culture date
The length of stay is determined by the hospital admission and discharge dates, which is collected from the medical record.
Disposition at Discharge
Time Frame: Up to 1 year from index culture date
The disposition at discharge is a composite of different locations, to which the subject is discharged (skilled nursing facility, home, long term acute care facility, transfer to another hospital, death, or hospice) and it is used to compare patient outcomes based on MDRO collected form the subject.
Charlson Score
Time Frame: At 90 days after discharge from the index hospitalization
Components of the Charlson Score are collected from the medical record and the Charlson comorbidity index is calculated to determine chronically ill subjects.
ICU Admissions
Time Frame: Up to 1 year from index culture date
The total number ICU days during the index hospitalization will be collected from the medical record to determine high risk populations and exposure.
Antibiotic Summary
Time Frame: Only during hospitalization and up to one year from index culture date
All antibiotics administered during the hospital stay will be collected from the medical record. The antibiotic name, duration of therapy, frequency of dosing, dosage, and reason for discontinuation will be collected for the antibiotics of interest.
Pitt Bacteremia Score
Time Frame: On the day of index culture
Components of the Pitt Bacteremia Score are collected from the medical record and the Pitt bacteremia score is calculated to determine acutely ill subjects.
Survival Status
Time Frame: 90 days from discharge or up to one year from index hospitalization.
Survival status will be collected through 90 days after discharge from index hospitalization, up to one year, to determine mortality.
Readmission Status
Time Frame: 90 days after discharge from index hospitalization.
Readmission data will be collected through 90 days after discharge from index hospitalization to determine readmission.
Secondary Outcomes
No secondary outcomes reported