Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.

NCT ID: NCT03031210

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-11
• Study Completion Date: 2027-06-01

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).

Detailed Description

A single-center, non-blinded, pragmatic, randomized-controlled, non-inferiority clinical trial will be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All patients three months old to 18 years of age who had symptoms and signs suggestive of non-severe community acquired pneumonia based on respiratory complaints and a pulmonary infiltrate identified by trained paediatricians or emergency physicians will be eligible to the present study. Study participants will be randomly allocated to receive either amoxicillin (90mg/kg per day) in twice or thrice daily regimen. Primary outcome will be treatment failure within 10 days of enrolment as defined by hospitalisation, need for a change in antibiotic (persistence of fever at 72 hours, clinical deterioration, comorbid condition or development of serious adverse reactions) and death. ED revisits within 72 hours, second course of antibiotic and clinical recurrence rates will be evaluated in the follow-up assessments as well as percent of adverse events encountered, number of days missed (work, school or daycare), coverage vaccination rate, protocol adherence and patient and parental satisfaction. The primary analysis will use an intention-to-treat approach. Per-protocol analysis will also be carried to compare the failure rate. Accounting to a maximal 10% drop-off rate, a sample size of 685 participants per arm was calculated to have a power of 90% to identify a difference of ≤ 5% with an alpha value of 0.05.

Conditions

Community-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Twice a day regimen

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

Group Type: EXPERIMENTAL

Amoxicillin

Intervention Type: DRUG

(90 mg/kg/day) twice daily

Thrice a day regimen

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

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

(90 mg/kg/day) twice daily

Interventions

Amoxicillin

(90 mg/kg/day) twice daily

Intervention Type: DRUG

Other Intervention Names

Amoxil

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jocelyn Gravel

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jocelyn Gravel, MD

Role: PRINCIPAL_INVESTIGATOR

Sainte-Justine Hospital

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jocelyn Gravel, MD

Role: CONTACT

graveljocelyn@hotmail.com

514-345-4931 ext. 2559

Ariane Boutin, MD

Role: CONTACT

arianeboutin@gmail.com

514-345-4931

Facility Contacts

Jocelyn Gravel, MD

Role: primary

graveljocelyn@hotmail.com

514-345-4931 ext. 2559

Ariane Boutin, MD

Role: backup

arianeboutin@gmail.com

514-345-4931

Other Identifiers

BID pneumonia

Identifier Type: -

Identifier Source: org_study_id