Overview

Hospitalised Pneumonia With Extended Treatment (HOPE) Study

Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
Summary
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:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Menzies School of Health Research
Collaborators:
Griffith University
Nanyang Technological University
Queensland University of Technology
Sarawak General Hospital
The University of Queensland
University of Malaya
Treatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
Criteria
Inclusion Criteria:

1. Hospitalised children aged 3-mo to 5-yrs (in Darwin, children have to be Indigenous)

2. Have features of severe pneumonia on admission (temperature >37.5 celsius or a history
of fever at home or observed at the referring clinic, age-adjusted tachypnoea
[respiratory rate>50 if <12-months; respiratory rate>40 if >12-months] with chest wall
recession and/or oxygen saturation <92% in air), and consolidation on chest X-ray as
diagnosed by treating clinician

3. After 1-3 days of IV antibiotics, are afebrile, with improved respiratory symptoms and
signs, oxygen saturation>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.

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