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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02783859




Registration number
NCT02783859
Ethics application status
Date submitted
5/05/2016
Date registered
26/05/2016
Date last updated
23/08/2018

Titles & IDs
Public title
Hospitalised Pneumonia With Extended Treatment (HOPE) Study
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
Secondary ID [1] 0 0
HOPE_V5_01022017
Universal Trial Number (UTN)
Trial acronym
HOPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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)


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion without chronic respiratory symptoms and signs or bronchiectasis. - 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.
Timepoint [1] 0 0
Clinical review at 24 months (range 23-25 months)
Secondary outcome [1] 0 0
The proportion with clinical cure (i.e. complete resolution of respiratory symptoms and signs). - 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.
Timepoint [1] 0 0
Clinical review week 4 (range 4-6 weeks)
Secondary outcome [2] 0 0
Time to next respiratory-related hospitalisation assessed by chart reviews - 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
Timepoint [2] 0 0
Clinical review week 4 (range 4-6 weeks)
Secondary outcome [3] 0 0
Adverse events - 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.
Timepoint [3] 0 0
Adverse events monitored while participant taking trial medication
Secondary outcome [4] 0 0
Nasopharyngeal bacteria antibiotic resistance patterns - 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.
Timepoint [4] 0 0
Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months)
Secondary outcome [5] 0 0
Gene expression data - Gene expression micro-arrays will be performed in a subgroup of children (where bloods can be obtained)
Timepoint [5] 0 0
Baseline (hospital admission) and 4-6 weeks (where possible)

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.
Minimum age
3 Months
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Menzies School of Health Research - Darwin
Recruitment postcode(s) [1] 0 0
0812 - Darwin
Recruitment outside Australia
Country [1] 0 0
Malaysia
State/province [1] 0 0
Sabah
Country [2] 0 0
Malaysia
State/province [2] 0 0
Sarawak
Country [3] 0 0
Malaysia
State/province [3] 0 0
Kuala Lumpur
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Griffith University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sarawak General Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Malaya
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The University of Queensland
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Queensland University of Technology
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Nanyang Technological University
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT02783859
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Chang, PhD
Address 0 0
Menzies School of Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anne Chang, PhD
Address 0 0
Country 0 0
Phone 0 0
+61889468565
Fax 0 0
Email 0 0
anne.chang@menzies.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02783859