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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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Starting January 2017 through November 2019
Available to whom?
Must have an executed CDA and sub-award with ARLG/Duke for this specific purpose.
Available for what types of analyses?
How or where can data be obtained?


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