Condition category
Infections and Infestations
Date applied
03/01/2009
Date assigned
25/03/2009
Last edited
25/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jan Bonhoeffer

ORCID ID

Contact details

University Children's Hospital Basel
Postfach
Basel
4005
Switzerland

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 measures

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

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

http://www.ukbb.ch/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes