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

Phase 3

Recruiting

• Conditions: Acute Respiratory Infection; Community Acquired Pneumonia; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621000967886
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-23
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

1)Previous participation in PATRIC Clinical Registry or PATRIC Platform Trial within the last 3 months.
2)Parent/guardian has insufficient English proficiency to understand the study materials.
3)Parent/guardian is unwilling to provide consent.
4)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
5)Complicated LRTI, defined by either confirmation or clinical suspicion of:
a.) empyema
b.) infected para-pneumonic effusion OR
c.) lung abscess.
6)Patient displays severe respiratory distress (i.e. observations meet the Severe – Score 3 definitions; see PARROT chart).
7)Patient has bilateral auscultatory findings with a likely diagnosis of uncomplicated viral induced wheeze, bronchiolitis or asthma.
8)Patient is Intolerant to oral medications (refusal or vomiting).
9)Patient is currently receiving antibiotic therapy or taken antibiotics within the last 7 days.
10)Patient has known intolerance or allergy to amoxicillin or penicillin.
11)Parent and/or carer unable to return for medical review in the setting of clinical deterioration or lives outside the Perth metropolitan area.
12)Any concern that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the proportion of children with symptom resolution (returning to pre-morbid health state, as assessed by parents/carers) assessed at 7 days following presentation. The outcome is assessed by parent report using a study specific electronic questionnaire on day 7 post-intervention commencement.[ Day 7 post-intervention commencement.]