Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001713280p
Ethics application status
Submitted, not yet approved
Date submitted
10/10/2018
Date registered
17/10/2018
Date last updated
17/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The incidence and pattern of Clostridium difficile infection (CDI) at Dunedin Hospital: A retrospective audit study.
Scientific title
The rate and pattern of Clostridium difficile infection (CDI) at Dunedin Hospital following the introduction of the PCR toxin gene test: A retrospective audit study.
Secondary ID [1] 296291 0
None
Universal Trial Number (UTN)
U1111-1222-0125
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clostridium difficile infections, as PCR+toxin+ and PCR+toxin- diagnoses 309964 0
Clostridium difficile infection ,as PCR+toxin+ and PCR+toxin- diagnoses, following closure of loop ileostomy 309965 0
Condition category
Condition code
Oral and Gastrointestinal 308739 308739 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 308793 308793 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Clostridium difficile infection (CDI) is a major hospital-acquired infection capable of causing complications ranging from diarrhoea to severe infection. In 2016 Dunedin Hospital, which historically has low rates of CDI, introduced a PCR test which identifies the genes which produce the CD toxin. We also perform an immunoassay test to directly identify the toxin. We aim to assess the impact of this new test on the incidence of diagnosis of CDI, and to assess the clinical significance of the combined result of a PCR gene positive test and an immunoassay toxin negative test. This will be done using hospital records for the period from 2014-2018.
Intervention code [1] 312621 0
Not applicable
Comparator / control treatment
A comparison will be made between patients before and after the introduction of a PCR test, which allows us to determine whether patients are positive for a CD toxin gene. Records for patients diagnosed between 2014 and 2018 will be included, with patients who were diagnosed after 2016 in the comparator group.
Control group
Historical

Outcomes
Primary outcome [1] 307729 0
The rate of Clostridium difficile diagnosis following the introduction of the PCR toxin gene test at Dunedin Hospital determined using electronic hospital records.
Timepoint [1] 307729 0
upon admission to the hospital
Secondary outcome [1] 352669 0
The antibiotic use associated with CDI in patients of Dunedin Hospital. This will be determined using electronic hospital records.
Timepoint [1] 352669 0
At hospital discharge.
Secondary outcome [2] 352670 0
The clinical course of diarrhea in patients with PCR +, Toxin - status. The course of diarrhea will be defined by the following laboratory and clinical parameters: White cell count, albumin, creatinine, length of stay (LOS), mortality within six weeks of diagnosis (as in Wilcox et al Lancet 2013). This will be determined using electronic data.
Timepoint [2] 352670 0
At hospital discharge.
Secondary outcome [3] 352671 0
The clinical course of diarrhea in patients with PCR +, toxin+ status. The course of diarrhea will be defined by the following laboratory and clinical parameters: White cell count, albumin, creatinine, length of stay (LOS), mortality within six weeks of diagnosis (as in Wilcox et al Lancet 2013). This will be determined using electronic data.
Timepoint [3] 352671 0
At hospital discharge.
Secondary outcome [4] 352725 0
The proton pump inhibitor use associated with CDI in patients of Dunedin Hospital. This will be determined using electronic hospital records.
Timepoint [4] 352725 0
From 2014-2018
Secondary outcome [5] 352728 0
The duration of hospital stay associated with CDI in patients of Dunedin Hospital. This will be determined using electronic hospital records.
Timepoint [5] 352728 0
At hospital discharge

Eligibility
Key inclusion criteria
Patients who have had a diagnosis of a Clostridium difficile infection at Dunedin Hospital from 2014-2018
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not applicable

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The incidence and pattern of CDI infection for patients who have PCR+, Toxin+ or PCR-, Toxin - status will be summarised using descriptive statistics of central tendency. In order to compare laboratory and clinical parameter differences between patients with PCR+toxin- CDI and PCR+toxin+ CDI, the differences between patients diagnosed in a medical or surgical ward, or the differences between patients with and without a closure of loop ileostomy after colon resection, we will use either the Student t- test or Mann-Whitney U test depending on the distribution of the variable. Statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2018
Actual
Date of last participant enrolment
Anticipated
1/01/2019
Actual
Date of last data collection
Anticipated
1/02/2019
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 20910 0
New Zealand
State/province [1] 20910 0
Otago

Funding & Sponsors
Funding source category [1] 300883 0
University
Name [1] 300883 0
Dunedin School of Medicine, University of Otago
Country [1] 300883 0
New Zealand
Primary sponsor type
University
Name
Dunedin School of Medicine, University of Otago
Address
201 Great King Street,
Dunedin, New Zealand 9016
Country
New Zealand
Secondary sponsor category [1] 300447 0
None
Name [1] 300447 0
Address [1] 300447 0
Country [1] 300447 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301656 0
University of Otago Human Ethics Committee (Health) Minimal Risk Health Research – Audit and audit related studies
Ethics committee address [1] 301656 0
Ethics committee country [1] 301656 0
New Zealand
Date submitted for ethics approval [1] 301656 0
03/09/2018
Approval date [1] 301656 0
Ethics approval number [1] 301656 0

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

Contacts
Principal investigator
Name 87682 0
Dr John Woodfield
Address 87682 0
Dunedin Schoool of Medicine
Department of Surgical Sciences
University of Otago
201 Great King Street
Dunedin 9016
Country 87682 0
New Zealand
Phone 87682 0
+64 3 474 0999
Fax 87682 0
Email 87682 0
[email protected]
Contact person for public queries
Name 87683 0
John Woodfield
Address 87683 0
Dunedin Schoool of Medicine
Department of Surgical Sciences
University of Otago
201 Great King Street
Dunedin 9016
Country 87683 0
New Zealand
Phone 87683 0
+64 3 474 0999
Fax 87683 0
Email 87683 0
[email protected]
Contact person for scientific queries
Name 87684 0
John Woodfield
Address 87684 0
Dunedin Schoool of Medicine
Department of Surgical Sciences
University of Otago
201 Great King Street
Dunedin 9016
Country 87684 0
New Zealand
Phone 87684 0
+64 3 474 0999
Fax 87684 0
Email 87684 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.