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Multi-Drug Resistant Organism Network

NCT03646227 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6496

Last updated 2023-03-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Standard of Care

There is no prescribed intervention for this study. Standard of care will be captured in the eCRF.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • David van Duin, MD. PhD · University of North Carolina

  • Robert Bonomo, MD · University Hospitals Cleveland Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-16
Primary Completion
2020-05-30
Completion
2020-05-30

Countries

  • United States
  • Australia
  • China
  • Colombia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646227 on ClinicalTrials.gov