A Phase 3 interventional study of Celestamine® in Community-acquired Pneumonia, sponsored by Julia Bielicki. Completed at 13 sites in 2 countries. Open to participants aged 6 Months to 14 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Julia Bielicki · Phase 3, Interventional, and Treatment
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Among 14 studies in Community-Acquired Pneumonia with a site in Switzerland — 4 open to participants now, 4 under way, 1 of them phase 3. Community-Acquired Pneumonia · Switzerland.
Among the 14 studies in Community-Acquired Pneumonia with a site in Switzerland, this one is the 6th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2018, is one of 4 in phase 3, and was the 8th registered.
325 studies on the registry are indexed under Community-Acquired Pneumonia; 78 are open to participants now.
Browse Community-Acquired Pneumonia studies →4 of the 14 studies in Community-Acquired Pneumonia with a site in Switzerland are open now. Recruiting first, the newest first:
Christoph Berger · Sites in Switzerland
Ages 3–17
University Hospital, Basel, Switzerland · Sites in Switzerland
Ages 18+ · Healthy volunteers
UMC Utrecht · Sites in Switzerland, United States, Australia and 26 more countries
Ages 28 days+
University of Zurich · Sites in Switzerland
Ages 18+
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 41 Community-Acquired Pneumonia studies recruiting now, 29 (71%) set no upper age limit and 9 (22%) stop at 75 or younger; 13 take children under 18; 5 take healthy volunteers.
This study: 6 Months to 14 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 510 is above the median of 246 across 196 interventional studies indexed under Community-Acquired Pneumonia.
Median enrollment 516 across the 10 interventional studies, 111 across the 4 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
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2 of 14 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Julia Bielicki as lead sponsor.
Julia Bielicki has 1 study filed under Community-Acquired Pneumonia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Community-Acquired Pneumonia with a site in Switzerland, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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Exclusion Criteria:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
oral betamethasone solution, once daily for two consecutive days at 0.1-0.2 mg/kg
Drug: Celestamine®
oral placebo matched to the product described above
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.
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.
Time frame: 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.
Time frame: from randomization until day 28
Ran from Oct 2018 to primary completion in Mar 2024, 64 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Community-Acquired Pneumonia →