Multi-Drug Resistant Organism Network (MDRO Network)
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| ClinicalTrials.gov Identifier: NCT03646227 |
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Recruitment Status :
Completed
First Posted : August 24, 2018
Last Update Posted : May 11, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Infections Resistant to Multiple Drugs Bacterial Infections | Other: Standard of Care |
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.
Aim 3. Provide data on expected outcomes of patients with MDRO infections for power and sample size calculations for future trials.
In the MDRO network, detailed outcomes data will be collected. Data will include survival and microbiologic clearance outcomes when available. In addition, anatomical site specific clinical symptomatic outcomes, modeled on FDA guidance documents, will be documented. Data obtained will aid in guiding the design of future clinical trials by providing data needed for power and sample size calculations.
All hospitalized patients, including pediatric patients, who have an MDRO isolated from a clinical culture will be included. Patients who have a positive culture for MDRO that is obtained outside the hospital setting will not be included, to ensure the ability to collect MDRO isolates and sufficient clinical data. Overall enrollment is expected to be 7000.
This study will request a waiver of informed consent, consistent with CFR Title 45 part 46.116(d). The study does not involve direct interaction with human subjects. The medical records of patients admitted to the hospital will be screened and data collected from those records according this protocol. The patients will not be approached to obtain information, no intervention is being tested. MDRO isolates will be obtained from existing standard of care microbial testing.
| Study Type : | Observational |
| Actual Enrollment : | 6496 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Multi-Drug Resistant Organism Network - MDRO Network |
| Actual Study Start Date : | June 16, 2016 |
| Actual Primary Completion Date : | May 30, 2020 |
| Actual Study Completion Date : | May 30, 2020 |
- Other: Standard of Care
There is no prescribed intervention for this study. Standard of care will be captured in the eCRF.
- 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.
- 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.
- 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.
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646227
| United States, North Carolina | |
| Duke Clinical Research Institute | |
| Durham, North Carolina, United States, 27705 | |
| Australia, Queensland | |
| The University of Queensland Centre for Clinical Research | |
| Herston, Queensland, Australia, 4029 | |
| China, Shanghai | |
| Huashan Hospital | |
| Shanghai, Shanghai, China, 200040 | |
| Colombia | |
| Universidad El Bosque | |
| Bogota, Colombia | |
| Principal Investigator: | David van Duin, MD. PhD | University of North Carolina | |
| Principal Investigator: | Robert Bonomo, MD | University Hospitals Cleveland Medical Center |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT03646227 |
| Other Study ID Numbers: |
Pro00071149 UM1AI104681 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 24, 2018 Key Record Dates |
| Last Update Posted: | May 11, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The resulting SAP and results will be shared and discussed within the MDRO Publications Committee for the purpose of manuscript developing, and to inform the design of future clinical trials. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Starting January 2017 through November 2019 |
| Access Criteria: | Must have an executed CDA and sub-award with ARLG/Duke for this specific purpose. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Carbapenem-resistant enterobacteriaceae (CRE) Carbapenem-resistant Pseudomonas aeruginosa (CRPA) Klebsiella pneumoniae |
Acinetobacter baumannii (CRAb) Bloodstream infection (BSI) Microbiological characterization |
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Infections Communicable Diseases Bacterial Infections |
Disease Attributes Pathologic Processes Bacterial Infections and Mycoses |