Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000972729
Ethics application status
Approved
Date submitted
6/04/2022
Date registered
11/07/2022
Date last updated
11/07/2022
Date data sharing statement initially provided
11/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Procalcitonin in the Febrile Paediatric Population
Scientific title
The Validity of Procalcitonin as a Screening Measure in the Febrile Paediatric Population of South Australia
Secondary ID [1] 306747 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Infections 325754 0
Condition category
Condition code
Emergency medicine 323091 323091 0 0
Other emergency care
Infection 323252 323252 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The information collected will be the patients medical history and the investigations performed on presentation to the hospital. These investigations are at the discretion of the clinicians but in order to be eligible for the study the clinicians will have needed to collect blood and a urine sample at a minimum. Other investigations (but not criteria for inclusion in the study) include cerebral spinal fluid, microbiological swabs and imaging such as chest X-rays.
There is no active involvement for the participants. Clinicians will be asked to fill out a form to highlight relevant patients to the study and from there the data collection will be done by the study clinicians.
The duration of the study is 2 years. The duration of observation of individual participants is the duration of time from when they present to the paediatric emergency until discharge.

To evaluate the validity of procalcitonin as a screening marker for predicting serious or invasive bacterial infections in febrile children between the ages of 0 and 18 years of age presenting to the paediatric emergency department.
Intervention code [1] 323196 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330860 0
The primary outcome is to assess the accuracy of blood protein marker Procalcitonin in detecting bacterial infections in the febrile paediatric population using data collected from investigations done on patient arrival to the paediatric emergency department.
Timepoint [1] 330860 0
The blood tests and investigations done will be on arrival to the paediatric emergency department with data collected after patient discharge.
Secondary outcome [1] 407855 0
To specifically assess the accuracy of procalcitonin in the paediatric age group less than 3 months of age in detecting bacterial infections from data collected from the investigations done when the patient arrived to the paediatric emergency department.
Timepoint [1] 407855 0
The blood tests and investigations done will be on arrival to the paediatric emergency department with data collected after patient discharge.
Secondary outcome [2] 407856 0
To assess the accuracy of procalcitonin for detecting bacterial infections between different paediatric age groups using the information retrieved from the investigations done on the patients presentation to the paediatric emergency department.
Timepoint [2] 407856 0
The blood tests and investigations done will be on arrival to the paediatric emergency department with data collected after patient discharge.

Eligibility
Key inclusion criteria
Patients from 0-18 years of age (including those <90 day corrected gestational age)
Febrile with an axillary or rectal temperature > 38 in emergency department or at home.
Clinician suspicion of a bacterial infection.
Blood cultures, procalcitonin, C-reactive protein and white cell count taken.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Antibiotics within the past 48 hours (including prior to intrahospital transfer)
Absence of fever by reliable method of measurement
Absence of relevant tests (1+ of blood culture, procalcitonin, white cell count, C-reactive protein)
Age > 18 years of age

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Based on a review of data of patients who presented to the emergency department and had relevant tests collected (CRP, PCT and WCC) from the previous 4 years we are expecting between 1500-2000 presentations of fever to Women’s and Children’s Hospital Emergency Department per year. Of these we expect at least a quarter to a half to meet the inclusion/exclusion criteria to fulfil enrolment. Over 2 years we are expecting 1000 patients to be enrolled.

Data analysis for both primary and secondary outcomes will be performed once all the data has been collected.

Calculation of means, standard deviations (SDs), rates, and ratios for all appropriate variables or if not evenly distributed use of medians and interquartile ranges.

Evaluation of differences in patient characteristics stratified by type of infection status. Of note a two tailed level of significance of p value less than 0.05 will be considered significant to all the tests.
Student’s t-test for parametric data
Mann-Whitney U-test for nonparametric data.
Fischer exact test for comparison of proportions.

McNemer Chi-square testing of all results.

Receiver operating characteristic (ROC) curve with 95% confidence interval (CI) for both CRP and PCT at different cut off points. We will calculate the area under the curve (AUC) of both ROC curves for predicting bacterial infection.

Calculation of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and negative and positive likelihood ratios (LR) for both tests. Logistic regression will be used to analyze CRP and PCT in predicting bacterial infection.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/08/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22010 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 37128 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 311083 0
Hospital
Name [1] 311083 0
Hospital - Womens and Childrens Hospital
Country [1] 311083 0
Australia
Primary sponsor type
Individual
Name
Ruth Jusaitis
Address
Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia, 5006
Country
Australia
Secondary sponsor category [1] 312452 0
None
Name [1] 312452 0
Address [1] 312452 0
Country [1] 312452 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310621 0
Women's and Children's Health Network Research Ethics Committee.
Ethics committee address [1] 310621 0
72 King William Rd, North Adelaide SA 5006
Ethics committee country [1] 310621 0
Australia
Date submitted for ethics approval [1] 310621 0
08/02/2022
Approval date [1] 310621 0
09/03/2022
Ethics approval number [1] 310621 0
2022/GEM00039

Summary
Brief summary
The majority of paediatric infections are benign and viral in origin, more serious infections - particularly of bacterial causes - are important to diagnosis and treat promptly. So the purpose of this study is to look at a investigation called procalcitonin and see if it can be accurately used as a prediction of bacterial infection. Then to look at the level of procalcitonin, in patients with bacterial infections, and compare it to other inflammatory markers, assess it against a timeline from fever onset, and look at it in comparison of different age groups. In order to do this we will have clinicians in the paediatric emergency department fill in a form of relevant patients to highlight those suitable for the study. Then after diagnosis and discharge we will look at data (that is investigations performed) pertaining to procalcitonin and infections and use this information to come to conclusions. The hypothesis is that procalcitonin is a sensitive and specific marker of bacterial infections, superior in both its sensitivity and specificity, as well as its rise in relation to fever onset, to other inflammatory markers and will be a useful marker in diagnosing bacterial infections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118290 0
Dr Ruth Jusaitis
Address 118290 0
Women's and Children's Hospital
72 King William Road
North Adelaide
SA
5006
Country 118290 0
Australia
Phone 118290 0
+61 0422575978
Fax 118290 0
Email 118290 0
ruth.jusaitis@sa.gov.au
Contact person for public queries
Name 118291 0
Dr Ruth Jusaitis
Address 118291 0
Women's and Children's Hospital
72 King William Road
North Adelaide
SA
5006
Country 118291 0
Australia
Phone 118291 0
+61 8 81617000
Fax 118291 0
Email 118291 0
ruth.jusaitis@sa.gov.au
Contact person for scientific queries
Name 118292 0
Dr Ruth Jusaitis
Address 118292 0
Women's and Children's Hospital
72 King William Road
North Adelaide
SA
5006
Country 118292 0
Australia
Phone 118292 0
+61 8 81617000
Fax 118292 0
Email 118292 0
ruth.jusaitis@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will not be sharing data with others


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.