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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age3-18
SponsorSt. Justine's Hospital

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amoxicillin

    Drug

    (90 mg/kg/day) twice daily

Treatment groups

1,370 Participants
are divided into 2 treatment groups
Group A: Twice a day regimenExperimental treatment 1 intervention
Group B: Thrice a day regimenActive comparator 1 intervention

Trial outcomes

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

Time frame
Day 10 (after enrolment)

Secondary outcomes

1

Emergency department revisit within 72 hours

Return to the emergency department in the following 72 hours

Time frame
72 hours
2

Second course of antibiotic

Necessity of second course of antibiotics

Time frame
1 month
3

Clinical recurrence

Another diagnosis of pneumonia

Time frame
1 month
4

Adverse events

Any adverse event

Time frame
10 days

Other outcomes

Sponsors and contacts

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