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New treatment option for Community-acquired Pneumonia
Official title Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.
ClinicalTrials.gov ID: NCT03031210
What this study is testing
What is Amoxicillin?
Amoxicillin is an investigational medicine, given as an once-daily, being studied as a potential treatment for community-acquired pneumonia.
Also referred to as Amoxil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- Any danger signs associated with pneumonia (severe indrawing, shock or severe dehydration, empyema, important pleural effusion, pulmonary abcess or...
- 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-...
See the full eligibility 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 will be required:
- 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
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.