KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP

NCT03474991 | Completed Phase 3 DMC

• 1 other identifier: 2018-00563; me15CC7
• Study Type: interventional
• Target: 510
• Locations: 2 countries
• Sites: 13

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

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (2)

• time to clinical stability

  The time to clinical stability after randomization in the active treated group (oral betamethasone for up to 2 days) as compared to the control group (placebo) will be one primary outcome.

  from randomization up to 2 days

• CAP-related re-admission measured by number of childs re-admitted to hospital due to CAP

  (ii) The proportion of children with CAP-related readmission within 28 days after randomization comparing oral betamethasone and placebo will be the co-primary outcome.

  from randomization until day 28

Study Arms (2)

Celestamine® N 0.5

ACTIVE COMPARATOR

oral betamethasone solution, once daily for two consecutive days at 0.1-0.2 mg/kg

Drug: Celestamine®

Placebo

PLACEBO COMPARATOR

oral placebo matched to the product described above

Drug: Celestamine®

Interventions

Celestamine® DRUG

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.

Celestamine® N 0.5; Placebo

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Julia Bielicki: lead
• Swiss National Fund for Scientific Research: collaborator
• University Hospital, Basel, Switzerland: collaborator
• SwissPedNet: collaborator

Study Sites (13)

Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Kinder- und Jugendmedizin

Bochum, Germany

Location

Universitätsklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie

Düsseldorf, Germany

Location

Universitätsklinikum Freiburg, Zentrum für Kinder und Jugendmedizin Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Tübingen, Klinik für Kinder- und Jugendmedizin

Tübingen, Germany

Location

Kantonsspital Aarau, Klinik für Kinder u. Jugendliche

Aarau, 5001, Switzerland

Location

University of Basel Children's Hospital (UKBB)

Basel, 4056, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Geneva University Hospital, Department of Pediatrics

Geneva, 1211, Switzerland

Location

Centre hospitalier universitaire vaudois

Lausanne, 1011, Switzerland

Location

Luzerner Kantonsspital, Kinderspital

Lucerne, 6000, Switzerland

Location

Ostschweizer Kinderspital

Sankt Gallen, 9006, Switzerland

Location

Kantonsspital- Freiburger Spital (HFR)

Villars-sur-Glâne, 1752, Switzerland

Location

University-Childrens Hospital Zürich

Zurich, 8032, Switzerland

Location

Related Publications (2)

• Kohns Vasconcelos M, Meyer Sauteur PM, Keitel K, Santoro R, Heininger U, van den Anker J, Bielicki JA. Strikingly Decreased Community-acquired Pneumonia Admissions in Children Despite Open Schools and Day-care Facilities in Switzerland. Pediatr Infect Dis J. 2021 Apr 1;40(4):e171-e172. doi: 10.1097/INF.0000000000003026. No abstract available.

  PMID: 33399433 DERIVED

• Kohns Vasconcelos M, Meyer Sauteur PM, Santoro R, Coslovsky M, Lura M, Keitel K, Wachinger T, Beglinger S, Heininger U, van den Anker J, Bielicki JA. Randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial. BMJ Open. 2020 Dec 29;10(12):e041937. doi: 10.1136/bmjopen-2020-041937.

  PMID: 33376176 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Johannes van der Anker, Prof MD

  University of Basel Children's Hospital (UKBB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-representative of University of Basel Children's Hospital (UKBB)

Model Details: KIDS-STEP is a phase III strategic investigator-initiated, randomised, placebo-controlled, fully blinded multicentre superiority trial with two parallel groups

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 23, 2018
• Study Start: October 28, 2018
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

CH (9); DE (4)