Twice daily amoxicillin treatment for children with non-severe pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a twice-daily regimen of amoxicillin compared to a thrice-daily regimen for treating non-severe community-acquired pneumonia in children aged 3 months to 18 years. Conducted at a pediatric emergency department, the study will randomly assign participants to receive either treatment regimen and monitor outcomes such as treatment failure, hospitalizations, and adverse events over a 10-day period. The trial aims to determine if the less frequent dosing is equally effective while also assessing patient satisfaction and adherence to the treatment protocol.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Sainte-Justine
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Jocelyn Gravel, MD — Sainte-Justine Hospital
• Study coordinator: Jocelyn Gravel, MD
• Email: graveljocelyn@hotmail.com
• Phone: 514-345-4931

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.