Children with community acquired pneumonia (CAP).
Conditions
Interventions
Trade Name: Celestamine
Product Name: Celestamine®
Pharmaceutical Form: Oral liquid
INN or Proposed INN: BETAMETHASONE
CAS Number: 378-44-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
Universitätskinderspital beider Basel (UKBB)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - At least 6 months of age and less than 14 years of age - Body weight between 5 kg and 45 kg - Admission to hospital (i.e. assignment of an inpatient case number or receipt of in-hospital treatment in a designated short stay unit) - Clinical diagnosis of CAP (see below) - 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 The following constellation of signs and symptoms will be taken to indicate a clinical diagnosis of CAP: -Temperature >= 38°C measured by any method or history of fever in last 48 hours reported by parents AND at least two of the following signs and/or symptoms: - Presence of cough (observed or reported in last 72 to 96 hours); - Increased age-specific respiratory rate as defined by Paediatric Advanced Life Support (PALS) guidelines during assessment in PED (first or second triage or clinical examination); - Hypoxaemia =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Presence of local complications (empyema, pleural effusion with clinically identified need for drainage, pneumothorax, and pulmonary abscess) - Chronic underlying disease associated with an increased risk of very severe CAP or CAP of unusual aetiology, such as sickle cell disease, primary or secondary immunodeficiency, chronic lung disease and cystic fibrosis - 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 - Parents are unlikely to be able to reliably participate in telephone follow-up because of significant language barriers - Participation in another study with an 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives include the evaluation of effects of oral betamethasone treatment (versus placebo) in children hospitalised for CAP on: - duration of primary hospital stay; - severity and duration of CAP symptoms; - intensive care unit admissions; - mortality; - rate and severity of solicited clinical side effects; - rate of serious adverse events;Primary end point(s): Co-primary outcomes: (i) The time to clinical stability after randomisation in the active treated group (oral betamethasone for up to 2 days) as compared to the control group (placebo) will be one primary outcome. (ii) The proportion of children with CAP-related readmission within 28 days after randomisation comparing oral betamethasone and placebo will be the co-primary outcome. Regarding (i): Clinical stability will be defined as the attending clinician assessing the child as being ready for hospital discharge or recorded normal respiratory rate, heart rate and oxygen saturation. Children discharged will be assumed to be clinically stable at discharge. For respiratory rate and heart rate, at least two consecutive age-related normal values as specified in the American Heart Association Accredited Pediatric Advance Life Support documentation will be taken to indicate stability. Oxygen saturation in room air of 92% or above will be considered normal. Rationale: Clinical stability is relevant to patients and their families as a prerequisite for hospital discharge, and can have considerable socioeconomic impacts on the child and parents by allowing a return to normal activity for the whole family. A rapid recovery with no respiratory problems and no need for supplemental oxygen represents directly patient-relevant components of this outcome. The average length of stay (LOS) of hospitalised children with CAP is 2 days and by 3-4 days more than 75% of children with this diagnosis have been discharged home 35, 36. This reflects the relatively rapid recovery of children with CAP c | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Time to resolution of vital sign abnormalities in hours. (with normalisation defined as above) •Time to hospital discharge after index hospitalisation in days. •Total duration of hospitalisation in days up to 28 days after randomisation. •Proportion of children (re)treated with antibiotics after discharge for any reason at 28 days after randomisation. •Proportion of children admitted to intensive care during the initial hospitalisation and up to 28 days after randomisation. •Proportion of children experiencing solicited side effects of the trial treatment and/or serious adverse events. •Duration of individual moderate-severe CAP symptoms in days, including cough, poor appetite and reduced activity assessed by a standardised and validated questionnaire to be completed by parents of participating children at week 1, 2 and 3 after randomisation. •Mortality up to 28 days after randomisation. ;Timepoint(s) of evaluation of this end point: end of study; interim analysis (blinded sample size re-estimation will be performed) | — |
Countries
Germany, Switzerland
Contacts
Public ContactKlinik für Pädiatrie, Neonatologie
Universitätsklinikum Düsseldorf
Outcome results
None listed