An intervention study to determine if a longer duration of antibiotics (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised for pneumonia

Phase 4

Completed

Conditions: Pneumonia in children
Respiratory - Other respiratory disorders / diseases
Infection - Studies of infection and infectious agents
Public Health - Other public health

Registration Number: ACTRN12616000046404

Lead Sponsor: Menzies School of Health Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 324

Inclusion Criteria

1) Hospitalised children aged 3-mo to <6-yrs (in Darwin, children have to be Indigenous)
(2) Have features of severe pneumonia on admission (temperature >37.50C or a history of fever at home or observed at the referring clinic, age-adjusted tachypnoea [RR>50 if <12-mo; RR>40 if >12-mo] with chest wall recession and/or SpO2 <92% in air), and consolidation on CXR as diagnosed by treating clinician
(3) After 1-3 days of IV antibiotics, are afebrile, with improved respiratory symptoms and signs, SpO2 >90% in air and are ready to be switched to oral amoxicillin-clavulanate, and
(4) Have symptoms of no longer than 7 days at point of hospitalisation.
(5) Recruited within 24 hours of admission to ward

Exclusion Criteria

(1) Current wheeze
(2) Underlying chronic illness other than asthma (e.g. bronchiectasis, cyanotic congenital heart disease or cardiac failure, neuromuscular disorders, immunodeficiency) that could potentially influence the current illness
(3) Severe malnutrition (weight-for-height Z-score <-3)
(4) Complicated (effusion, empyema or abscess) pneumonia, including tuberculosis
(5) Extra-pulmonary infection requiring antibiotic therapy (e.g. meningitis)
(6) Beta-lactam allergy
(7) Previously enrolled
(8) Lack a mobile phone and/or unable to return for follow-up clinic visits during the next 24 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion without chronic respiratory symptoms and signs or bronchiectasis. We will capture any further chronic respiratory symptoms and signs or bronchiectasis though the child’s medical records (community or hospital) and clinical review[ We aim to review these children at 24 months, However, many children will reside in geographically isolated locations, thus a range of 23-26 months is a reasonable time frame to capture clinically important outcomes.]

Secondary Outcome Measures