Betamethasone therapy in hospitalised children with community acquired pneumonia (CAP).
- Conditions
- Children with community acquired pneumonia (CAP).Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-005097-25-DE
- Lead Sponsor
- niversitätskinderspital beider Basel (UKBB)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 510
- 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 <92% in room air as measured by transcutaneous oxygen monitoring;
- Signs of laboured/ difficult breathing, including nasal flaring, chest retractions, grunting,
abdominal breathing and shortness of breath;
- Clinical signs of lobar pneumonia including focal dullness to percussion, focal reduced breath
sounds, crackles with asymmetry.
- Children younger than 6 month of age will not be included as a high proportion of acute lower
respiratory tract infections affecting infants are episodes of bronchiolitis which are known not to benefit from corticosteroid treatment
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method