Recruiting
Phase 2
Phase 3

Amoxicillin

Sponsor:

St. Justine's Hospital

Code:

NCT03031210

Conditions

Community-acquired Pneumonia

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Amoxicillin

Study Details

Brief 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).

Conditions

Community-acquired Pneumonia

Study ID

NCT03031210

Start date

Jun 11, 2017

Status verified date

May, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Inclusion 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 inclusion criteria will be required:

1. Presence of respiratory symptoms (cough and/or dyspnea)
2. Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles)
3. Presence of fever
4. Positive chest radiography as interpreted by the treating physician

Exclusion Criteria:

  • 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), aspiration pneumonia or recurrent pneumonias.
  • 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

Study Design

Enrollment

1370 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Amoxicillin

(90 mg/kg/day) twice daily

Primary outcome measure

  • Clinical failure within 10 days of enrolment [ Time Frame: Day 10 (after enrolment) ]

Central Contacts and Locations

Central contacts

Locations

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T1C5

Contacts

Principal Investigator:

Jocelyn Gravel, MD

More Information

Sponsor

St. Justine's Hospital

Last update posted

May 14, 2025

Last verified

May, 2025

Keywords

  • Non-severe community-acquired pneumonia
  • Amoxicillin treatment
  • Twice daily antibiotic regimen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2025-05-14.