The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired pneumonia in children presenting at a paediatric Emergency Department (ED).
Eligibility
Sex
ALL
Min age
3 Months
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* All patients 3 months to 18 years of age attending the pediatric ED and diagnosed with a non-severe pneumonia, will be considered for enrolment. More precisely, the following inclusion criteria will be required:
1. Presence of respiratory symptoms (cough and/or dyspnea)
2. Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles)
3. Presence of fever
4. Positive chest radiography as interpreted by the treating physician
Exclusion Criteria:
* Any danger signs associated with pneumonia (severe indrawing, shock or severe dehydration, empyema, important pleural effusion, pulmonary abcess or pneumatocoele)
* History of anaphylactic or allergic reaction to penicillin or amoxicillin according to the treating physician.
* History of a serious nonimmunoglobulin E-mediated reactions (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis) attributed to amoxicilin.
* Caregiver unable to provide consent (language barrier or lack of caregiver presence)
* Underlying unstable chronic illness (ie. cystic fibrosis, immune suppression, active tuberculosis, bronchiectasis or active pulmonary malignancies)
* Persistent/chronic pneumonia syndromes (with symptoms for \>2 weeks), suspected by the physician to be caused by atypical pathogens, hospital- acquired pneumonia (been hospitalized within 2 weeks prior to enrolment), aspiration pneumonia or recurrent pneumonias.
* Any history of receiving amoxicillin within the past month
* Need hospitalisation for any other reasons (ie. persistent vomiting, severe life-threatening infection such as septicaemia or meningitis requiring intravenous antimicrobial agents)
* Previous participation in study
Primary outcome measure(s)
Clinical failure within 10 days of enrolment — Day 10 (after enrolment) As a primary outcome, clinical failure will be defined by any of the following occurring within 10 days of enrolment:
* Death or hospitalisation
* A need for a change in antibiotic according to the treating physician. In our settings, common reasons to change antibiotic are:
* Persistence of fever at 72h
* Clinical deterioration:
• Clinical deterioration will include the development of lower chest-wall indrawing, central cyanosis, stridor while calm, or danger signs as defined by: inability to drink or breastfeed, convulsions, persistent vomiting, lethargy, or unconsciousness at any time during a child's treatment.
* Development of a comorbid condition such as a meningitis, bacteriemia, osteomyelitis or septic arthritis
* Allergic reaction
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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