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

St. Justine's Hospital

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Community-acquired Pneumonia

Treatments: Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT03031210

BID pneumonia

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,370 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,370 participants in 2 patient groups

Twice a day regimen

Experimental group

Description:

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

Treatment:

Drug: Amoxicillin

Thrice a day regimen

Active Comparator group

Description:

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

Treatment:

Drug: Amoxicillin