Clinical trial NCT02783859: Hospitalised Pneumonia With Extended Treatment (HOPE) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pneumonia
Keywords: Children
Anti-Bacterial Agents
Indigenous Population
Hospitals
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: Griffith University
name: Sarawak General Hospital
name: University of Malaya
name: The University of Queensland
name: Queensland University of Technology
name: Nanyang Technological University
First posted: 2016-05-26
Enrollment: 314
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: The proportion without chronic respiratory symptoms and signs or bronchiectasis.
timeFrame: Clinical review at 24 months (range 23-25 months)
Secondary outcomes:
measure: The proportion with clinical cure (i.e. complete resolution of respiratory symptoms and signs).
timeFrame: Clinical review week 4 (range 4-6 weeks)
measure: Time to next respiratory-related hospitalisation assessed by chart reviews
timeFrame: Clinical review week 4 (range 4-6 weeks)
measure: Adverse events
timeFrame: Adverse events monitored while participant taking trial medication
measure: Nasopharyngeal bacteria antibiotic resistance patterns
timeFrame: Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months)
measure: Gene expression data
timeFrame: Baseline (hospital admission) and 4-6 weeks (where possible)
Other outcomes:
Locations:
city: Darwin
country: Australia
facility: Menzies School of Health Research
state: Northern Territory
city: Kota Kinabalu
country: Malaysia
facility: Sabah Women and Children's Hospital
state: Sabah
city: Sibu
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre and Klang Hospital
city: Auckland
country: New Zealand
facility: Starship Children's Hospital & KidzFirst Hospital
Study officials:
affiliation: Menzies School of Health Research
name: Anne Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: