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Community-acquired PneumoniaPhase 3KIDS-STEPNCT03474991

KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP

A Phase 3 study testing Celestamine® in people with Community-acquired Pneumonia, run by Julia Bielicki at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 14 years
Conditions the study is for
Community-acquired Pneumonia
What is being tested?
Celestamine®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
510 participants
Where
13 sitesin 2 countries
Study dates
28 Oct 2018to 26 Mar 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Switzerland9 sites
  • Kantonsspital Aarau, Klinik für Kinder u. Jugendliche

    Aarau, 5001

  • University of Basel Children's Hospital (UKBB)

    Basel, 4056

  • Inselspital Bern

    Bern, 3010

  • Geneva University Hospital, Department of Pediatrics

    Geneva, 1211

  • Centre hospitalier universitaire vaudois

    Lausanne, 1011

  • Luzerner Kantonsspital, Kinderspital

    Lucerne, 6000

  • Ostschweizer Kinderspital

    Sankt Gallen, 9006

  • Kantonsspital- Freiburger Spital (HFR)

    Villars-sur-Glâne, 1752

  • University-Childrens Hospital Zürich

    Zurich, 8032

Other trials in Switzerland

Germany4 sites
  • Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Kinder- und Jugendmedizin

    Bochum

  • Universitätsklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie

    Düsseldorf

  • Universitätsklinikum Freiburg, Zentrum für Kinder und Jugendmedizin Freiburg

    Freiburg im Breisgau

  • Universitätsklinikum Tübingen, Klinik für Kinder- und Jugendmedizin

    Tübingen

Other trials in Germany

About this study

Official title: A Randomised Placebo-controlled Multi-centre Effectiveness Trial of Adjunct Betamethasone Therapy in Hospitalised Children With Community Acquired Pneumonia (CAP)

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.

Read the 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 a high rate of hospitalisation (around 10/1000 child-years). In low-and middle-income settings, pneumonia is the leading infectious cause of death in children less than 5 years of age. In high-income settings, working mothers of children hospitalised with CAP have been reported to loose on average 4.2 workdays compared with 1.7 workdays for children with CAP managed in primary care. In addition to this economic burden, there is a substantial impact on quality of life for the affected child and the family. Children who are admitted with CAP experience on average 13 nonroutine days with slightly shorter periods of decreased appetite (8.5 days), disordered sleep (4.5 days) and absence from routine out-of-home childcare (7.5 days). Any intervention that ensures rapid clinical stabilization allowing for early hospital discharge without negative impacts on the overall recovery in children hospitalised with CAP would therefore carry substantial socioeconomic benefits.

Only few small trials have addressed the potential impact of oral steroid treatment in CAP during childhood. Nagy et al reported a significant reduction in fever duration and length of stay in children with severe CAP receiving methylprednisolone for 5 days compared with children receiving placebo in a randomised trial with 59 participants. A randomised trial comparing adjunct dexamethasone or methylprednisolone against standard of care (no placebo) planning to enroll 40 participants was being set up but has been withdrawn prior to recruitment (NCT01631916). A placebo-controlled randomised trial of adjunct corticosteroids in CAP complicated by pleural effusion and/or empyema with 56 participants has been completed (NCT01261546), but has not yet reported on its findings. An observational analysis using propensity scores found that adjunct corticosteroids were associated with a shorter hospital stay only in children also receiving beta-agonist therapy, concluding that any benefit might only be seen in children with acute wheezing. All in all, there is a lack of pragmatic randomized controlled trials ( RCT) with sufficient power and high external validity to provide a definitive answer to the question of the effect of adjunct steroids in children hospitalised with CAP.

Infection-related unwanted effects of adjunct steroids are potentially relevant in the context of childhood CAP. A higher proportion of children hospitalised with CAP reaching early clinical stability would only be desirable if this were shown not to be offset by a higher rate of clinically relevant CAP recurrence. A rebound phenomenon after corticosteroid discontinuation has been postulated to explain a higher rate of infection recurrence (19% compared with 9% in placebo group) among adults. Data from a recent individual patient data metaanalysis, however, indicate that an increased risk of CAP recurrence may be rather associated with longer duration of adjunct steroids in adults with CAP. To our knowledge, the question about the effect of adjunct steroid treatment in childhood CAP in relation to a postulated rebound phenomenon measured clinically as CAP recurrence has not been formally addressed in a trial. CAP-specific readmission rates for children are low at around 5%. In bronchiolitis, another acute lower respiratory tract infection for which oral corticosteroid treatment has been investigated, an increased risk of hospital revisits associated with steroid treatment could not be identified in a Cochrane metaanalysis.

Being tested
Celestamine®
Medical subject headings
Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03474991
Study groupRoleWhat they receive
Celestamine® N 0.5Active comparatororal betamethasone solution, once daily for two consecutive days at 0.1-0.2 mg/kg
Receives: Drug: Celestamine®
PlaceboPlacebo comparatororal placebo matched to the product described above
Receives: Drug: Celestamine®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: from randomization up to 2 days

  2. 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.

    Measured: from randomization until day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2018
  2. Study start28 Oct 2018
  3. Primary completion26 Mar 2024
  4. Study completion26 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
KIDS-STEP is a phase III strategic investigator-initiated, randomised, placebo-controlled, fully blinded multicentre superiority trial with two parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03474991
Sponsor's protocol ID
2018-00563; me15CC7
Other IDs
2018
Acronym
KIDS-STEP
Status last verified
Feb 2025
First submitted
16 Mar 2018
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33399433
  • 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.

    PubMed 33376176

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Celestamine® in people with Community-acquired Pneumonia, run by Julia Bielicki at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to clinical stability (time frame: from randomization up to 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03474991, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

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