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Hospitalised Pneumonia With Extended Treatment (HOPE) Study (HOPE)

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ClinicalTrials.gov Identifier: NCT02783859
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
Griffith University
Sarawak General Hospital
University of Malaya
The University of Queensland
Queensland University of Technology
Nanyang Technological University
Information provided by (Responsible Party):
Menzies School of Health Research

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

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Amoxicillin-clavulanic Acid Drug: Placebo (for Amoxicillin-clavulanic Acid) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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)
Drug: Amoxicillin-clavulanic Acid
Placebo Comparator: Placebo arm
8 days of oral placebo (equivalent volume as the active arm)
Drug: Placebo (for Amoxicillin-clavulanic Acid)



Primary Outcome Measures :
  1. The proportion without chronic respiratory symptoms and signs or bronchiectasis. [ Time Frame: Clinical review at 24 months (range 23-25 months) ]
    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.


Secondary Outcome Measures :
  1. The proportion with clinical cure (i.e. complete resolution of respiratory symptoms and signs). [ Time Frame: Clinical review week 4 (range 4-6 weeks) ]
    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.

  2. Time to next respiratory-related hospitalisation assessed by chart reviews [ Time Frame: Clinical review week 4 (range 4-6 weeks) ]
    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

  3. Adverse events [ Time Frame: Adverse events monitored while participant taking trial medication ]
    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.

  4. Nasopharyngeal bacteria antibiotic resistance patterns [ Time Frame: Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months) ]
    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.

  5. Gene expression data [ Time Frame: Baseline (hospital admission) and 4-6 weeks (where possible) ]
    Gene expression micro-arrays will be performed in a subgroup of children (where bloods can be obtained)



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783859


Contacts
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Contact: Anne Chang, PhD +61889468565 ext 8565 anne.chang@menzies.edu.au
Contact: Gabrielle McCallum, PhD +61889468565 ext 8565 gabrielle.mccallum@menzies.edu.au

Locations
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Australia, Northern Territory
Menzies School of Health Research Recruiting
Darwin, Northern Territory, Australia, 0812
Contact: Gabrielle McCallum, PhD    +61889468565    gabrielle.mccallum@menzies.edu.au   
Contact: Anne Chang, PhD    +61889468565    anne.chang@menzies.edu.au   
Principal Investigator: Anne Chang, PhD         
Malaysia
Sabah Women and Children's Hospital Recruiting
Kota Kinabalu, Sabah, Malaysia, 88996
Contact: Moy Fong, MBBS    +60 88-522 600    fongsm@gmail.com   
Contact: Gabrielle McCallum, PhD    +61889468565    gabrielle.mccallum@menzies.edu.au   
Sarawak General Hospital Recruiting
Sibu, Sarawak, Malaysia, 96000
Contact: Mong Ooi, MBBS MRCP    +6 084 343333    monghow@pd.jaring.my   
Contact: Gabrielle McCallum, PhD    +61889468565    gabrielle.mccallum@menzies.edu.au   
University Malaya Medical Centre and Klang Hospital Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Anna Nathan, MRCP MBBch    +603 7949 3643    annamarie@um.edu.my   
Contact: Jessie de Bruyne, MRCP, MBBS    +603-79492065    debruyne@um.edu.my   
New Zealand
Starship Children's Hospital & KidzFirst Hospital Recruiting
Auckland, New Zealand, 1142
Contact: Catherine Byrnes, MD    64 9 923 9770    c.byrnes@auckland.ac.nz   
Contact: Gabrielle McCallum, PhD    +61408866611    gabrielle.mccallum@menzies.edu.au   
Sponsors and Collaborators
Menzies School of Health Research
Griffith University
Sarawak General Hospital
University of Malaya
The University of Queensland
Queensland University of Technology
Nanyang Technological University
Investigators
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Principal Investigator: Anne Chang, PhD Menzies School of Health Research

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Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT02783859     History of Changes
Other Study ID Numbers: HOPE_V5_01022017
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Menzies School of Health Research:
Children
Anti-Bacterial Agents
Indigenous Population
Hospitals

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors