Clinical Research Details

Descriptive Information
Multi-Drug Resistant Organisms (MDRO) Network

Souha Kanj Shararah
sk11@aub.edu.lb

BIO-2017-0479
Ongoing

Observational  


No
Sponsors
  • Antibiotic Resistance Leadership Group (ARLG)
Coordinators
Jeff Jabbour
jj24@aub.edu.lb
Conditions and Keywords
The study's main focus is the collection of samples and clinical data on patients with positive MDRO in-patients.
MDRO,Carbapenem-resistant microorganisms
Study Design
Screening
N/A: Not Applicable
Prospective
Open Label
N/A: Not Applicable
N/A: Not Applicable
Cohort
Eligibility and IRB
Both
Min: 0
Max:
Yes
No

The objective of this multi-national study is to provide observational data that will aid in the design of randomized clinical trials on 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.


The population includes hospitalized in-patients with a positive MDRO culture.


The MDRO Network will enroll at multiple sites globally.For each patient identified as having an MDRO, the data manager at the site 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) for the study’s centralized database. 

All MDROisolates will be sent to the central research laboratories for molecular and microbiologic analysis. Molecular and microbiologic analyses may include, but will not be limited to, antimicrobial susceptibility testing, determination of resistance, and strain typing.


All hospitalized patients, including pediatric patients, who have at least one MDRO isolated from a clinical culture will be eligible for inclusion.


Patients who only have a positive culture for MDRO that is obtained outside the hospital setting and do not have a positive culture for MDRO during hospitalization.