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

NCT03031210 | Recruiting Phase 2 DMC

• 1 other identifier: BID pneumonia
• Study Type: interventional
• Target: 1,370
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical failure within 10 days of enrolment

  As a primary outcome, clinical failure will be defined by any of the following occurring within 10 days of enrolment: * Death or hospitalisation * A need for a change in antibiotic according to the treating physician. In our settings, common reasons to change antibiotic are: * Persistence of fever at 72h * Clinical deterioration: • Clinical deterioration will include the development of lower chest-wall indrawing, central cyanosis, stridor while calm, or danger signs as defined by: inability to drink or breastfeed, convulsions, persistent vomiting, lethargy, or unconsciousness at any time during a child's treatment. * Development of a comorbid condition such as a meningitis, bacteriemia, osteomyelitis or septic arthritis * Allergic reaction

  Day 10 (after enrolment)

Secondary Outcomes (6)

• Emergency department revisit within 72 hours

  72 hours

• Second course of antibiotic

  1 month

• Clinical recurrence

  1 month

• Adverse events

  10 days

• Number of working days missed by caregivers or school/daycare days missed by patients

  1 month

Study Arms (2)

Twice a day regimen

EXPERIMENTAL

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

Drug: Amoxicillin

Thrice a day regimen

ACTIVE COMPARATOR

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

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

(90 mg/kg/day) twice daily

Also known as: Amoxil

Thrice a day regimen; Twice a day regimen

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jocelyn Gravel, MD

  Sainte-Justine Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyn Gravel, MD

CONTACT

514-345-4931; graveljocelyn@hotmail.com

Ariane Boutin, MD

CONTACT

514-345-4931; arianeboutin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: June 11, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)