RecruitingPhase 2Phase 3NCT03031210

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

Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.

Sponsor

St. Justine's Hospital

Enrollment

1,370 participants

Start Date

Jun 11, 2017

Study Type

INTERVENTIONAL

Conditions

Community-acquired Pneumonia

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).

Eligibility

Min Age: 3 MonthsMax Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria9

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