CompletedPhase 4

Hospitalised Pneumonia With Extended Treatment (HOPE) Study

Australia, Malaysia, New Zealand314 participantsStarted 2016-06

Plain-language 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

Who can participate

Age range3 Months – 5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Hospitalised children aged 3-mo to 5-yrs (in Darwin, children have to be Indigenous)
✓. 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
✓. 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
✓. Have symptoms of no longer than 7 days at point of hospitalisation.

Exclusion criteria

✕. Current wheeze
✕. 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
✕. Severe malnutrition (weight-for-height Z-score \<-3)
✕. Complicated (effusion, empyema or abscess) pneumonia, including tuberculosis
✕. Extra-pulmonary infection requiring antibiotic therapy (e.g. meningitis)
✕. Beta-lactam allergy
✕. Previously enrolled
✕. Lack a mobile phone and/or unable to return for follow-up clinic visits during the next 24 months

What they're measuring

The proportion without chronic respiratory symptoms and signs or bronchiectasis.

Timeframe: Clinical review at 24 months (range 23-25 months)

Trial details

NCT IDNCT02783859

SponsorMenzies School of Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06

View on ClinicalTrials.gov More Pneumonia trials