About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Presence of respiratory symptoms (cough and/or dyspnea)
Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles)
Presence of fever
Positive chest radiography as interpreted by the treating physician
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Amoxicillin
Drug(90 mg/kg/day) twice daily
Treatment groups
Trial outcomes
Primary outcomes
Clinical failure within 10 days of 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
Secondary outcomes
Emergency department revisit within 72 hours
Return to the emergency department in the following 72 hours
Second course of antibiotic
Necessity of second course of antibiotics
Clinical recurrence
Another diagnosis of pneumonia
Adverse events
Any adverse event
Sponsors and contacts
Click on the lead sponsor to view all of their trials.