Status:
COMPLETED
KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP
Lead Sponsor:
Julia Bielicki
Collaborating Sponsors:
Swiss National Fund for Scientific Research
University Hospital, Basel, Switzerland
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
6-14 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to concurrently evaluate whether adjunct treatment with corticosteroids in children hospitalized with CAP is more effective in terms of the proportion of children reaching...
Detailed Description
The incidence of community-acquired pneumonia (CAP) in young children remains high (20- 30/1000 child-years) even in high-income settings with routine pneumococcal vaccination, and is associated with ...
Eligibility Criteria
Inclusion
- Body weight between 5 kg and 45 kg
- Admission to hospital (i.e. assignment of an inpatient case number)
- Clinical diagnosis of CAP (according to predefined criteria)
- Parent and/or child (as age-appropriate) willing to accept all possible randomised allocations and to be contacted by telephone weekly up to and including at 4 weeks after randomisation
- Informed consent form for trial participation signed by parent
Exclusion
- Presence of local chest complications
- Chronic underlying disease associated with an increased risk of very severe CAP or CAP of unusual aetiology
- Bilateral wheezing without focal chest signs AND clinical indication for primary administration of steroids (most likely to represent respiratory tract infection affecting the medium airways, i.e. not pneumonia)
- Admission to hospital with a primary clinical diagnosis of bronchiolitis
- Inability to tolerate oral medication
- Documented allergy or any other known contraindication to any trial medication
- Subacute or chronic conditions requiring higher betamethasone equivalent or known primary or secondary adrenal insufficiency
- Known diabetes mellitus (type 1)
- Hospitalisation within the last two weeks preceding current admission with the possibility that pneumonia could be hospital-acquired or healthcare-associated
- Completion of a course of systemic corticosteroids within 2 weeks from enrolment for courses of \>5 days
- Transfer for any reason to a non-participating hospital directly from the paediatric emergency department
- Parent are unlikely to be able to reliably participate in telephone follow-up because of significant language barriers
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, and other dependent persons.
Key Trial Info
Start Date :
October 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2024
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT03474991
Start Date
October 28 2018
End Date
March 26 2024
Last Update
February 24 2025
Active Locations (13)
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1
Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Kinder- und Jugendmedizin
Bochum, Germany
2
Universitätsklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie
Düsseldorf, Germany
3
Universitätsklinikum Freiburg, Zentrum für Kinder und Jugendmedizin Freiburg
Freiburg im Breisgau, Germany
4
Universitätsklinikum Tübingen, Klinik für Kinder- und Jugendmedizin
Tübingen, Germany