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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02783859
Registration number
NCT02783859
Ethics application status
Date submitted
5/05/2016
Date registered
26/05/2016
Date last updated
7/04/2022
Titles & IDs
Public title
Hospitalised Pneumonia With Extended Treatment (HOPE) Study
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Scientific 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
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Secondary ID [1]
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HOPE_V5_01022017
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Universal Trial Number (UTN)
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Trial acronym
HOPE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumonia
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Amoxicillin-clavulanic Acid
Treatment: Drugs - Placebo (for Amoxicillin-clavulanic Acid)
Experimental: Active arm: Amoxicillin-clavulanic Acid - 8 days of oral amoxicillin-clavulanic Acid 400/57 duo formulation (70-90mg/kg/day, twice daily dosing: max 980mg per day)
Placebo Comparator: Placebo arm - 8 days of oral placebo (equivalent volume as the active arm)
Treatment: Drugs: Amoxicillin-clavulanic Acid
Treatment: Drugs: Placebo (for Amoxicillin-clavulanic Acid)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The proportion without chronic respiratory symptoms and signs or bronchiectasis.
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Assessment method [1]
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Any further chronic respiratory symptoms and signs or bronchiectasis though the child's medical records (community or hospital) will be captured. These children will be reviewed at 24 months, however many children will reside in geographically isolated locations, thus a range of 23-25 months is a reasonable timeframe to capture clinically important outcomes.
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Timepoint [1]
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Clinical review at 24 months (range 23-25 months)
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Secondary outcome [1]
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The proportion with clinical cure (i.e. complete resolution of respiratory symptoms and signs).
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Assessment method [1]
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Children will have a standardised respiratory clinical assessment, completed by either a member of the study team or health provider. These children will be reviewed at week 4, however many children will reside in geographically isolated locations, thus a range of 4-6 weeks is a reasonable time frame to capture clinically important outcomes.
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Timepoint [1]
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Clinical review week 4 (range 4-6 weeks)
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Secondary outcome [2]
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Time to next respiratory-related hospitalisation assessed by chart reviews
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Assessment method [2]
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Data will be captured through chart reviews of children's medical records (e.g. hospital and/or community health record) and/or information from parents in next 12 months
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Timepoint [2]
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Clinical review week 4 (range 4-6 weeks)
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Secondary outcome [3]
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Adverse events
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Assessment method [3]
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Adverse effects will be monitored (anorexia, nausea, vomiting, abdominal pain, diarrhoea, rashes) while children are actively taking trial medication (e.g. 8 days). Parents will also keep a diary of adverse events.
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Timepoint [3]
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Adverse events monitored while participant taking trial medication
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Secondary outcome [4]
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Nasopharyngeal bacteria antibiotic resistance patterns
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Assessment method [4]
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Nasopharyngeal respiratory antibiotic resistance will be assessed using nasal swabs. Nasopharyngeal respiratory bacterial pathogens and antibiotic resistance will be assessed using research laboratory's previously published methods.
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Timepoint [4]
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Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months)
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Secondary outcome [5]
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Gene expression data
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Assessment method [5]
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Gene expression micro-arrays will be performed in a subgroup of children (where bloods can be obtained)
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Timepoint [5]
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Baseline (hospital admission) and 4-6 weeks (where possible)
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Eligibility
Key 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.
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Minimum age
3
Months
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Maximum age
5
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2022
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Actual
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Sample size
Target
314
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NT
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Recruitment hospital [1]
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Menzies School of Health Research - Darwin
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Recruitment postcode(s) [1]
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0812 - Darwin
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Recruitment outside Australia
Country [1]
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Malaysia
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State/province [1]
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Sabah
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Country [2]
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Malaysia
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State/province [2]
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Sarawak
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Country [3]
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Malaysia
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State/province [3]
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Kuala Lumpur
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Country [4]
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New Zealand
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State/province [4]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Menzies School of Health Research
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Griffith University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Sarawak General Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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University of Malaya
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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The University of Queensland
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Queensland University of Technology
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Nanyang Technological University
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Address [6]
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Country [6]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02783859
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anne Chang, PhD
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Address
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Menzies School of Health Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02783859
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