Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of procalcitonin guidance on antibiotic use, quality of care, hospitalisation, and time to recovery in children with lower respiratory tract infections
Acronym
ProPAED
Study hypothesis
Respiratory tract infections are the leading cause of medical consultations and antibiotic (AB) prescriptions in childhood. Improving the diagnostic accuracy, facilitating early detection of LRTIs in need of AB therapy, reducing AB misuse and decreasing unnecessary utilisation of hospital resources for lower respiratory tract infections (LRTI) will improve patient care and may have a major impact on reducing AB resistance and heath care costs.
Hypothesis:
Compared to management according to internationally recognised guidelines, procalcitonin (PCT) guidance will lead to reduced AB use overall, earlier detection of LRTI in need of AB treatment and decreased hospitalisation rate, with a similar clinical outcome and time to recovery measured by days of restriction due to the LRTI.
Ethics approval
Ethics Committee of Basel, approved in January 2009 (ref: EKBB 369/08)
Study design
Open randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Patient information sheet can be found at: http://propaed.pidb.ch/propaed/
Condition
Paediatric lower respiratory tract infections
Intervention
Stratified by centre and type of LRTI, patients will be randomised to management according to internationally recognised guidelines ("guideline group") versus PCT-guided AB therapy ("PCT group"). In the control group, the use of internationally recognised guidelines for the management of LRTIs will be strictly adhered to. In the PCT group, initiation or continuation of AB will be increasingly discouraged (<0.25 or <0.1 ug/L) or increasingly encouraged (>0.25 or >0.5 ug/L) based on the PCT level. In AB-treated outpatients or discharged patients, the duration of AB will be based on the most recent PCT level. A re-evaluation after 6 to 24 hours is recommended if AB are withheld.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Antibiotic prescription rate at Day 1, 3, 5 and 14.
Secondary outcome measures
1. Time to recovery (days with restriction from LRTI)
2. Rate and duration of hospitalisation
3. Complication rate
4. Measures of laboratory and clinical outcome
5. Side effects from AB
6. Disease activity scores
Endpoints will be assessed at day 1, 3 and 5 in the form of a medical consultation at the hospital, and after 14 days by structured phone interviews conducted by blinded investigators.
Overall trial start date
10/01/2009
Overall trial end date
09/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, 1 month to 18 years of age
2. Two pre-specified sub-groups will be recruited:
2.1. Patients with acute LRTI based on clinical diagnosis
2.2. Patients with X-ray confirmed community acquired pneumonia (CAP)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
338
Participant exclusion criteria
1. Patients who have been hospitalised within the previous 14 days
2. Patients with immune-suppression, chronic infection, or a terminal condition
3. Patients lacking informed consent
4. Insufficient knowledge of German (in a family member)
Recruitment start date
10/01/2009
Recruitment end date
09/01/2010
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Children's Hospital Basel
Basel
4005
Switzerland
Sponsor information
Organisation
University Children's Hospital Basel (Switzerland)
Sponsor details
Postfach
Basel
4005
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Children's Hospital Basel (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list