Ignite Creation Date:
2024-05-06 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03474991
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2018-03-16
Brief Title:
KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP
Sponsor:
Julia Bielicki
Organization:
University Childrens Hospital Basel
Study Overview
Official Title:
A Randomised Placebo-controlled Multi-centre Effectiveness Trial of Adjunct Betamethasone Therapy in Hospitalised Children With Community Acquired Pneumonia CAP
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KIDS-STEP
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
Detailed Description:
The incidence of community-acquired pneumonia CAP in young children remains high 20- 301000 child-years even in high-income settings with routine pneumococcal vaccination and is associated with a high rate of hospitalisation around 101000 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 42 workdays compared with 17 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 85 days disordered sleep 45 days and absence from routine out-of-home childcare 75 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None