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KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP

NCT03474991 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2025-02-24

No results posted yet for this study

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.

Conditions

  • Community-acquired Pneumonia

Interventions

DRUG

Celestamine®

Children in KIDS-STEP will be receiving either oral betamethasone (Celestamine®) or oral placebo dosed once daily for two consecutive days. Celestamine® N 0.5 liquidum is a betamethasone solution and will be used in the active comparator arm. Study medication will be administered orally once a day on two consecutive days. A standard dose of 0.1-0.2 mg/kg will be used. All doses used in KIDS-STEP fall into the range of recommended doses according to the Summary of Medical Product Characteristics.

Sponsors & Collaborators

  • Swiss National Fund for Scientific Research

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • SwissPedNet

    collaborator UNKNOWN

  • Julia Bielicki

    lead OTHER

Principal Investigators

  • Johannes van der Anker, Prof MD · University of Basel Children's Hospital (UKBB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-28
Primary Completion
2024-03-26
Completion
2024-03-26

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03474991 on ClinicalTrials.gov