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Procalcitonin in the Paediatric Population

The Validity of Procalcitonin as a Screening Measure in the Paediatric Population of South Australia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000972729
Enrollment
5097
Registered
2022-07-11
Start date
2022-10-01
Completion date
2024-09-30
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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. 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.

Interventions

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

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.

Sponsors

Ruth Jusaitis
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026