Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03646227




Registration number
NCT03646227
Ethics application status
Date submitted
15/08/2018
Date registered
24/08/2018
Date last updated
6/03/2023

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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03646227
Trial related presentations / publications
Clatworthy AE, Pierson E, Hung DT. Targeting virulence: a new paradigm for antimicrobial therapy. Nat Chem Biol. 2007 Sep;3(9):541-8. doi: 10.1038/nchembio.2007.24.
Infectious Diseases Society of America (IDSA); Spellberg B, Blaser M, Guidos RJ, Boucher HW, Bradley JS, Eisenstein BI, Gerding D, Lynfield R, Reller LB, Rex J, Schwartz D, Septimus E, Tenover FC, Gilbert DN. Combating antimicrobial resistance: policy recommendations to save lives. Clin Infect Dis. 2011 May;52 Suppl 5(Suppl 5):S397-428. doi: 10.1093/cid/cir153. No abstract available.
Vardakas KZ, Rafailidis PI, Konstantelias AA, Falagas ME. Predictors of mortality in patients with infections due to multi-drug resistant Gram negative bacteria: the study, the patient, the bug or the drug? J Infect. 2013 May;66(5):401-14. doi: 10.1016/j.jinf.2012.10.028. Epub 2012 Nov 6.
Zasowski EJ, Rybak JM, Rybak MJ. The beta-Lactams Strike Back: Ceftazidime-Avibactam. Pharmacotherapy. 2015 Aug;35(8):755-70. doi: 10.1002/phar.1622.
Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.
American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available. Erratum In: Am J Infect Control. 2008 Nov;36(9):655.
van Duin D, Perez F, Rudin SD, Cober E, Hanrahan J, Ziegler J, Webber R, Fox J, Mason P, Richter SS, Cline M, Hall GS, Kaye KS, Jacobs MR, Kalayjian RC, Salata RA, Segre JA, Conlan S, Evans S, Fowler VG Jr, Bonomo RA. Surveillance of carbapenem-resistant Klebsiella pneumoniae: tracking molecular epidemiology and outcomes through a regional network. Antimicrob Agents Chemother. 2014 Jul;58(7):4035-41. doi: 10.1128/AAC.02636-14. Epub 2014 May 5.
Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
Chow JW, Yu VL. Combination antibiotic therapy versus monotherapy for gram-negative bacteraemia: a commentary. Int J Antimicrob Agents. 1999 Jan;11(1):7-12. doi: 10.1016/s0924-8579(98)00060-0.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
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