Trial | NCT02783859  Report issue

Title

Hospitalised Pneumonia With Extended Treatment (HOPE) Study
A Multi-centre Double-blind Randomised Controlled Trial to Determine if a Longer Duration of Amoxicillin-clavulanic Acid (Compared to Shorter Duration) Improves Clinical Outcomes of Children Hospitalised With Community-acquired Pneumonia

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    314
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
A multi-centre double-blind randomised controlled trial to determine if a longer duration of amoxicillin-clavulanic acid (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised with community-acquired pneumonia, in Indigenous children and a developing country
Study Started
Jun 30
2016
Primary Completion
Jun 30
2022
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
Apr 07
2022

Drug Placebo (for Amoxicillin-clavulanic Acid)

Drug Amoxicillin-clavulanic Acid

Active arm: Amoxicillin-clavulanic Acid Experimental

8 days of oral amoxicillin-clavulanic Acid 400/57 duo formulation (70-90mg/kg/day, twice daily dosing: max 980mg per day)

Placebo arm Placebo Comparator

8 days of oral placebo (equivalent volume as the active arm)

Criteria 

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
No Results Posted