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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03646227




Registration number
NCT03646227
Ethics application status
Date submitted
15/08/2018
Date registered
24/08/2018

Titles & IDs
Public title
Multi-Drug Resistant Organism Network
Scientific title
Multi-Drug Resistant Organism Network - MDRO Network
Secondary ID [1] 0 0
UM1AI104681
Secondary ID [2] 0 0
Pro00071149
Universal Trial Number (UTN)
Trial acronym
MDRO Network
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections Resistant to Multiple Drugs 0 0
Bacterial Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Standard of Care

Other interventions: Standard of Care
There is no prescribed intervention for this study. Standard of care will be captured in the eCRF.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disposition at Discharge
Timepoint [1] 0 0
Up to 1 year from index culture date
Primary outcome [2] 0 0
Charlson Score
Timepoint [2] 0 0
At 90 days after discharge from the index hospitalization
Primary outcome [3] 0 0
Pitt Bacteremia Score
Timepoint [3] 0 0
On the day of index culture
Primary outcome [4] 0 0
Source of positive culture
Timepoint [4] 0 0
At collection of the MDRO isolates
Primary outcome [5] 0 0
Length of Stay
Timepoint [5] 0 0
Up to 1 year from index culture date
Primary outcome [6] 0 0
ICU Admissions
Timepoint [6] 0 0
Up to 1 year from index culture date
Primary outcome [7] 0 0
Antibiotic Summary
Timepoint [7] 0 0
Only during hospitalization and up to one year from index culture date
Primary outcome [8] 0 0
Survival Status
Timepoint [8] 0 0
90 days from discharge or up to one year from index hospitalization.
Primary outcome [9] 0 0
Readmission Status
Timepoint [9] 0 0
90 days after discharge from index hospitalization.

Eligibility
Key inclusion criteria
* Hospitalized patients.
* Must have at least one multi-drug resistant organism isolated from a clinical culture while hospitalized.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/05/2020
Sample size
Target
Accrual to date
Final
6496
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The University of Queensland Centre for Clinical Research - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
China
State/province [2] 0 0
Shanghai
Country [3] 0 0
Colombia
State/province [3] 0 0
Bogota

Funding & Sponsors
Primary sponsor type
Other
Name
Duke University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Allergy and Infectious Diseases (NIAID)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David van Duin, MD. PhD
Address 0 0
University of North Carolina
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03646227