Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Justine's Hospital
• Treatments: Amoxicillin

Criteria

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