Usefulness of a novel biomarker procalcitonin to guide antibiotic therapy in children with chest infections
| ISRCTN | ISRCTN17057980 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17057980 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/01/2009
- Registration date
- 25/03/2009
- Last edited
- 30/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jan Bonhoeffer
Scientific
Scientific
University Children's Hospital Basel
Postfach
Basel
4005
Switzerland
Study information
| Study design | Open randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Patient information sheet can be found at: http://propaed.pidb.ch/propaed/ |
| Scientific title | Effect of procalcitonin guidance on antibiotic use, quality of care, hospitalisation, and time to recovery in children with lower respiratory tract infections |
| Study acronym | ProPAED |
| Study objectives | 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(s) | Ethics Committee of Basel, approved in January 2009 (ref: EKBB 369/08) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 10/01/2009 |
| Completion date | 09/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 338 |
| Total final enrolment | 337 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 10/01/2009 |
| Date of final enrolment | 09/01/2010 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Children's Hospital Basel
Basel
4005
Switzerland
4005
Switzerland
Sponsor information
University Children's Hospital Basel (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Postfach
Basel
4005
Switzerland
| Website | http://www.ukbb.ch/ |
|---|---|
"ROR" |
https://ror.org/02nhqek82 |
Funders
Funder type
Hospital/treatment centre
University Children's Hospital Basel (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/08/2013 | 30/12/2020 | Yes | No |
Editorial Notes
30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
