Actively Recruiting

Phase 2
Phase 3
Age: 3Months - 18Years
All Genders
Healthy Volunteers
NCT03031210

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

Led by St. Justine's Hospital · Updated on 2025-05-14

1370

Participants Needed

1

Research Sites

520 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Months - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 3 months to 18 years attending the pediatric ED with non-severe pneumonia
  • Presence of respiratory symptoms such as cough and/or difficulty breathing
  • Signs of pneumonia including fast breathing, abnormal breath sounds, or crackles
  • Fever present
  • Chest X-ray showing pneumonia as interpreted by the treating physician
Not Eligible

You will not qualify if you...

  • Signs of severe pneumonia such as severe chest indrawing, shock, severe dehydration, empyema, large pleural effusion, lung abscess, or pneumatocoele
  • History of allergic or anaphylactic reaction to penicillin or amoxicillin
  • History of serious non-immunoglobulin E-mediated reactions to amoxicillin (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis)
  • Caregiver unable to provide consent due to language barrier or absence
  • Unstable chronic illnesses like cystic fibrosis, immune suppression, active tuberculosis, bronchiectasis, or lung cancer
  • Persistent or chronic pneumonia lasting more than 2 weeks, suspected atypical pathogens, hospital-acquired pneumonia, aspiration pneumonia, or recurrent pneumonia
  • Received amoxicillin within the past month
  • Need for hospitalization for other reasons such as persistent vomiting or severe infections requiring intravenous antibiotics
  • Previous participation in this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Sainte-Justine

Montreal, Quebec, Canada, H3T1C5

Actively Recruiting

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Research Team

J

Jocelyn Gravel, MD

CONTACT

A

Ariane Boutin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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