Twice daily amoxicillin treatment for children with non-severe pneumonia
Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.
This study is testing if giving children with mild pneumonia amoxicillin twice a day works just as well as giving it three times a day.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1370 (estimated) |
| Ages | 3 Months to 18 Years |
| Sex | All |
| Sponsor | St. Justine's Hospital Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT03031210 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 months to 18 years presenting with respiratory symptoms and diagnosed with non-severe community-acquired pneumonia.
Not a fit: Patients with severe pneumonia symptoms or a history of allergic reactions to amoxicillin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could simplify antibiotic treatment regimens for children with pneumonia, potentially improving adherence and outcomes.
How similar studies have performed: Previous studies have shown promising results with similar antibiotic regimens, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.