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Penicillin Antibiotic
Amoxicillin for Pneumonia
Phase 2 & 3
Recruiting
Led By Jocelyn Gravel, MD
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of respiratory symptoms (cough and/or dyspnea)
Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles)
Must not have
Need hospitalization for any other reasons (ie. persistent vomiting, severe life-threatening infection such as septicemia or meningitis requiring intravenous antimicrobial agents)
Any danger signs associated with pneumonia (severe indrawing, shock or severe dehydration, empyema, important pleural effusion, pulmonary abscess or pneumatocoele)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Summary
This trial will compare a twice-daily to a thrice-daily antibiotic regimen for the treatment of non-severe community acquired pneumonia in children.
Who is the study for?
This trial is for children aged 3 months to 18 years with non-severe community acquired pneumonia, showing symptoms like cough, fever, and abnormal breath sounds. They must have signs of pneumonia on a chest X-ray. Kids with severe allergic reactions to amoxicillin, chronic illnesses, or recent hospital stays are excluded.Check my eligibility
What is being tested?
The study tests if taking the antibiotic Amoxicillin twice daily is just as effective as three times daily for treating non-severe pneumonia in kids who visit the emergency department.See study design
What are the potential side effects?
Amoxicillin may cause side effects such as allergic reactions (rash), gastrointestinal issues (nausea, vomiting), and rarely more serious conditions like Stevens-Johnson syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms like coughing or difficulty breathing.
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I am showing signs of pneumonia, like rapid breathing and unusual lung sounds.
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I am between 3 months and 18 years old with a diagnosis of non-severe pneumonia.
Select...
I have a fever.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not need hospitalization for conditions like severe infections.
Select...
I have severe symptoms related to pneumonia.
Select...
I do not have any unstable chronic illnesses like cystic fibrosis or active TB.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical failure within 10 days of enrolment
Secondary outcome measures
Adverse events
Clinical recurrence
Emergency department revisit within 72 hours
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Twice a day regimenExperimental Treatment1 Intervention
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily.
Group II: Thrice a day regimenActive Control1 Intervention
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin
2017
Completed Phase 4
~7780
Find a Location
Who is running the clinical trial?
St. Justine's HospitalLead Sponsor
196 Previous Clinical Trials
77,972 Total Patients Enrolled
Jocelyn Gravel, MDPrincipal InvestigatorSainte-Justine Hospital
5 Previous Clinical Trials
1,587 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had serious skin reactions to amoxicillin in the past.You had a serious allergic reaction to penicillin or amoxicillin, as confirmed by your doctor.I have symptoms like coughing or difficulty breathing.I am showing signs of pneumonia, like rapid breathing and unusual lung sounds.Your doctor sees something concerning on your chest X-ray.I have had pneumonia symptoms for more than 2 weeks or have been hospitalized for pneumonia recently.I do not need hospitalization for conditions like severe infections.I am between 3 months and 18 years old with a diagnosis of non-severe pneumonia.I have severe symptoms related to pneumonia.You have taken amoxicillin in the last month.I do not have any unstable chronic illnesses like cystic fibrosis or active TB.I have a fever.
Research Study Groups:
This trial has the following groups:- Group 1: Thrice a day regimen
- Group 2: Twice a day regimen
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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