TerminatedPhase 3Phase 4ACTRN12621000967886

Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) : Amoxicillin Duration

Pragmatic Adaptive Trial for Respiratory Infections in Children Platform: Amoxicillin Duration

Sponsor

Telethon Kids Institute

Enrollment

500 participants

Start Date

Feb 26, 2022

Study Type

Interventional

Conditions

Acute Respiratory Infection

Summary

Acute respiratory infection (ARI) is a common cause of childhood morbidity and the most common reason for paediatric emergency department presentation and hospitalisation. Despite numerous professional bodies describing the limited trial data available to inform management guidelines, there has been little progress towards evidence-based ARI care in developed nations in the past decade. Antimicrobial use (or misuse) is a major driver for antimicrobial resistance (AMR) and identified by the WHO as an urgent threat to the prevention and treatment of an ever-increasing range of infections. AMR is a serious threat to global public health, requiring urgent action across all government sectors and society. Most antibiotics in children are prescribed for common paediatric conditions, particularly ARI. Our group has demonstrated that >50% of ARI-episodes are confirmed to be secondary to viral infections, yet >50% of children with fever and cough are prescribed antibiotics. Therefore, most antibiotics prescribed to children with ARI are likely to be unhelpful and given the impact on AMR, potentially harmful. The primary objective of this trial is to generate the evidence for optimal duration of antibiotic treatment for pneumonia and ARIs in children. This trial will compare different treatment arms of amoxicillin for 2, 3, 4 or 5 days for physician-diagnosed pneumonia in children aged greater than or equal to 6 months to 15 years.

Eligibility

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 15 Yearss

Inclusion Criteria4

Participants must be aged between greater than or equal to 6 months and 15 years.
Presence of fever and cough in the past 96 hours.
Total duration of symptoms <21 days at the time of enrolment.
Physician-diagnosed pneumonia; OR acute lower respiratory infection where antibiotics would be considered

Exclusion Criteria19

Previous participation in PATRIC Clinical Registry or PATRIC Platform Trial within the last 3 months.
Parent/guardian has insufficient English proficiency to understand the study materials.
Parent/guardian is unwilling to provide consent.
Severe lower respiratory tract infection, identified by:
a.) the presence of hypoxia in room air (<90%)
b.) the presence of WHO-defined danger signs (see definitions)
c.) if sepsis is suspected OR
d.) requiring ICU admission
Complicated LRTI, defined by either confirmation or clinical suspicion of:
a.) empyema
b.) infected para-pneumonic effusion OR
c.) lung abscess.
Patient displays severe respiratory distress (i.e. observations meet the Severe – Score 3 definitions; see PARROT chart).
Patient has bilateral auscultatory findings with a likely diagnosis of uncomplicated viral induced wheeze, bronchiolitis or asthma.
Patient is Intolerant to oral medications (refusal or vomiting).
Patient is currently receiving antibiotic therapy or taken antibiotics within the last 7 days.
Patient has known intolerance or allergy to amoxicillin or penicillin.
Parent and/or carer unable to return for medical review in the setting of clinical deterioration or lives outside the Perth metropolitan area.
Any concern that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study.

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Interventions

Name: Amoxicillin (250mg/5mL) Dose: 25mg/kg per dose, 3 times per day for participants up to 40kg Duration: 2-5 days of therapy (Arms 1-4) Arm 1 - 2 days of therapy Arm 2 - 3 days of therapy Arm

Name: Amoxicillin (250mg/5mL) Dose: 25mg/kg per dose, 3 times per day for participants up to 40kg Duration: 2-5 days of therapy (Arms 1-4) Arm 1 - 2 days of therapy Arm 2 - 3 days of therapy Arm 3 - 4 days of therapy Arm 4 - 5 days of therapy (standard of care) Mode: Oral syrup Name: Amoxicillin 500mg capsule Dose: 25mg/kg per dose, 3 times per day for participants over 40kg Duration: 2-5 days of therapy (Arms 1-4) Arm 1 - 2 days of therapy Arm 2 - 3 days of therapy Arm 3 - 4 days of therapy Arm 4 - 5 days of therapy (standard of care) Mode: Oral capsules Intervention adherence to the randomised dose will be self-reported in follow-up electronic surveys.