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Multi-Drug Resistant Organism Network (MDRO Network)

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ClinicalTrials.gov Identifier: NCT03646227
Recruitment Status : Enrolling by invitation
First Posted : August 24, 2018
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment
Infections Resistant to Multiple Drugs Bacterial Infections Other: Standard of Care

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.

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.


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Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-Drug Resistant Organism Network - MDRO Network
Actual Study Start Date : June 16, 2016
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Standard of Care
    There is no prescribed intervention for this study. Standard of care will be captured in the eCRF.


Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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
A sample of all MDRO isolates (bacterial isolates) will be sent to a central research laboratory for molecular and microbiological characterization. In addition, antimicrobial susceptibility testing, determination of mechanisms of antibiotic resistance, and strain typing will be performed.


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohorts will be constructed for each MDRO of eligible patients by investigating hospitalized patients who have an MDRO isolated in clinical cultures from any anatomical site. This study will be conducted under a waiver of informed consent to facilitate universal inclusion. All patients who are admitted to one of the participating hospitals and who have an MDRO - as defined in the specific sub-study protocol (Appendices) - isolated in a clinical culture are targeted for inclusion.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: David van Duin, MD. PhD University of North Carolina
Principal Investigator: Robert Bonomo, MD University Hospitals Cleveland Medical Center

Additional Information:
Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03646227     History of Changes
Other Study ID Numbers: Pro00071149
UM1AI104681 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Carbapenem-resistant enterobacteriaceae (CRE)
Carbapenem-resistant Pseudomonas aeruginosa (CRPA)
Klebsiella pneumoniae
Acinetobacter baumannii (CRAb)
Bloodstream infection (BSI)
Microbiological characterization

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections