NCT03031210 Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.
| NCT ID | NCT03031210 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | St. Justine's Hospital |
| Condition | Community-acquired Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,370 participants |
| Start Date | 2017-06-11 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,370 participants in total. It began in 2017-06-11 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jocelyn Gravel, MD
PRINCIPAL INVESTIGATOR
Sainte-Justine Hospital
Frequently Asked Questions
Who can join the NCT03031210 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 18 Years, studying Community-acquired Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03031210 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03031210 currently recruiting?
Yes, NCT03031210 is actively recruiting participants. Contact the research team at graveljocelyn@hotmail.com for enrollment information.
Where is the NCT03031210 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT03031210 clinical trial?
NCT03031210 is sponsored by St. Justine's Hospital. The principal investigator is Jocelyn Gravel, MD at Sainte-Justine Hospital. The trial plans to enroll 1,370 participants.