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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking amoxicillin twice a day is as effective as taking it three times a day for treating non-severe pneumonia in children. The researchers aim to determine if fewer doses remain effective while being safe and manageable for families. Children aged 3 months to 18 years who exhibit pneumonia symptoms, such as cough, fever, and abnormal breathing sounds, and have a positive chest X-ray, may qualify for this trial. As a Phase 2, Phase 3 trial, this research evaluates the treatment's effectiveness in a larger group and serves as the final step before FDA approval, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that giving amoxicillin twice a day is generally safe and effective for treating mild pneumonia in children. One study found that this schedule is effective and causes few serious side effects.

Another study confirmed that amoxicillin is effective and safe whether given twice or three times a day for children with mild pneumonia. This suggests that taking it less often might still be safe and effective.

Amoxicillin, a widely used antibiotic, is approved for other illnesses, which increases confidence in its safety. Current research suggests that children can take amoxicillin safely with minimal concern about side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for pneumonia?

Researchers are excited about the amoxicillin regimens for pneumonia because they explore dosing schedules that might improve convenience and adherence. Unlike the standard thrice-a-day regimen for amoxicillin, which is commonly used, the twice-a-day regimen offers a potentially simpler and easier-to-follow schedule without reducing the total daily dose. This could make treatment more manageable for patients and caregivers, potentially improving overall outcomes by ensuring that patients complete their full course of antibiotics.

What evidence suggests that this trial's treatments could be effective for pneumonia?

Research has shown that amoxicillin effectively treats mild pneumonia. Studies have found that amoxicillin works as well as co-trimoxazole, another antibiotic, for this condition. In fact, amoxicillin matches the effectiveness of some stronger antibiotics for hospitalized pneumonia patients. One study found that a short course of amoxicillin, such as five days, successfully treated about 85% of patients. In this trial, participants will receive amoxicillin either twice or three times a day, with both regimens proving effective for treating mild pneumonia. ^{6 7 8 9 10}

Who Is on the Research Team?

Jocelyn Gravel, MD

Principal Investigator

Sainte-Justine Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3843303/

Clinical Effectiveness of Co-trimoxazole vs. Amoxicillin in the ... Although in various studies including the present one, amoxicillin has come out to be better drug in the treatment of non severe pneumonia, it can not be ...

2. medrxiv.org medrxiv.org/content/10.1101/2025.09.05.25335164v1

Effectiveness of amoxicillin and amoxicillin-clavulanate for ... Conclusion Our study found no strong evidence of any difference in clinical outcomes with amoxicillin compared to amoxicillin-clavulanate or ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1761064/

Clinical efficacy of co-trimoxazole versus amoxicillin twice ... Conclusions: Both amoxicillin and co-trimoxazole were equally effective in non-severe pneumonia. Good follow up of patients is essential to prevent worsening of ...

4. evidence.nihr.ac.uk evidence.nihr.ac.uk/alert/amoxicillin-is-effective-for-many-people-hospitalised-with-pneumonia/

Amoxicillin is effective for many people hospitalised with ... Amoxicillin (a narrow-spectrum antibiotic) was as effective as a broad-spectrum antibiotic for people admitted to hospital with pneumonia.

5. jpeds.com jpeds.com/article/S0022-3476(21)00636-3/fulltext

Five vs 10 day amoxicillin course for pneumonia In intention-to-treat analysis, 108 of 126 (85.7%) in the 5-day amoxicillin group and in 106 of 126 (84.1%) in the 10-day group demonstrated clinical cure, risk ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278182/

Evaluating the Use of Amoxicillin in Community-Acquired ... Despite the small sample size and lack of comorbidity adjustment, the study found a high discharge rate (40 patients, or 86.95%) and low ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7118969/

Antimicrobial therapy of community-acquired pneumonia - PMC A β-lactam (high-dose amoxicillin [eg, 1 g three times daily; or 2 g of amoxicillin/clav 2 twice daily is preferred]. Alternatives: cefpodoxime, cefuroxime ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01200706

Clinical Efficacy of Amoxicillin Given Twice or Three Times ... The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or three times a day to children with non-severe community-acquired ...

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2785716

Effect of Amoxicillin Dose and Treatment Duration on the ... The trial findings suggest that a lower total daily amoxicillin dose may be used in twice-daily dosing regimens, especially when prevalence of ...

10. academic.oup.com academic.oup.com/jac/article/69/7/1954/2911121

Comparison of oral amoxicillin given thrice or twice daily to ... In conclusion, amoxicillin may be given as a 25 mg/kg/dose twice a day to children with non-severe pneumonia because it is not only efficacious but also safe.