KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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 clinical stability and whether such adjunct treatment is no worse in terms of CAP relapse.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborator: Swiss National Fund for Scientific Research
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 (most likely to represent respiratory tract infection affecting the medium airways, i.e. not pneumonia)

• 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

• 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.