Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.
Who is this study for? Patients with non-severe community acquired pneumonia
What treatments are being studied? Amoxicillin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 18
Healthy Volunteers: t
View:
• 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:
‣ 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
Locations
Other Locations
Canada
CHU Sainte-Justine
RECRUITING
Montreal
Contact Information
Primary
Jocelyn Gravel, MD
graveljocelyn@hotmail.com
514-345-4931
Backup
Ariane Boutin, MD
arianeboutin@gmail.com
514-345-4931
Time Frame
Start Date: 2017-06-11
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 1370
Treatments
Experimental: Twice a day regimen
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily.
Active_comparator: Thrice a day regimen
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily.
Related Therapeutic Areas
Sponsors
Leads: St. Justine's Hospital