Amoxicillin for Pneumonia

Overseen By Jocelyn Gravel, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: St. Justine's Hospital

Must not be taking: Penicillin, Amoxicillin

Disqualifiers: Allergy to penicillin, Amoxicillin, Unstable chronic illness, Recent amoxicillin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

1370 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Jocelyn Gravel, MD

Principal Investigator

Sainte-Justine Hospital

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

You have had serious skin reactions to amoxicillin in the past.

Previous participation in study

You had a serious allergic reaction to penicillin or amoxicillin, as confirmed by your doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a twice-daily or thrice-daily regimen of amoxicillin for non-severe community acquired pneumonia

10 days

Follow-up

Participants are monitored for treatment failure, adverse events, and clinical recurrence

1 month

Includes telephone survey and potential ED revisits

Treatment Details

Interventions

• Amoxicillin

Trial Overview 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.

Participant Groups

Group I: Twice a day regimen Experimental Treatment 1 Intervention

Patients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily.

Group II: Thrice a day regimen Active Control 1 Intervention

Patients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily.

Amoxicillin is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Amoxicillin for:

• Bacterial infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections
• Ear, nose and throat infections

Approved in United States as Amoxicillin for:

• Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract

Approved in Canada as Amoxicillin for:

• Bacterial infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+