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

Primary Purpose

Pneumonia

Status

Active

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Amoxicillin-clavulanic Acid

Placebo (for Amoxicillin-clavulanic Acid)

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Children, Anti-Bacterial Agents, Indigenous Population, Hospitals

Eligibility Criteria

3 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Menzies School of Health Research
Sabah Women and Children's Hospital
Sarawak General Hospital
University Malaya Medical Centre and Klang Hospital
Starship Children's Hospital & KidzFirst Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active arm: Amoxicillin-clavulanic Acid

Placebo arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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.

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.

Gene expression data

Gene expression micro-arrays will be performed in a subgroup of children (where bloods can be obtained)

Full Information

NCT ID

NCT02783859

First Posted

May 5, 2016

Last Updated

April 5, 2022

Sponsor

Menzies School of Health Research

Collaborators

Griffith University, Sarawak General Hospital, University of Malaya, The University of Queensland, Queensland University of Technology, Nanyang Technological University

1. Study Identification

Unique Protocol Identification Number

NCT02783859

Brief Title

Hospitalised Pneumonia With Extended Treatment (HOPE) Study

Acronym

HOPE

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 2016 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Menzies School of Health Research

Collaborators

Griffith University, Sarawak General Hospital, University of Malaya, The University of Queensland, Queensland University of Technology, Nanyang Technological University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia

Keywords

Children, Anti-Bacterial Agents, Indigenous Population, Hospitals

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active arm: Amoxicillin-clavulanic Acid

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Amoxicillin-clavulanic Acid

Intervention Type

Drug

Intervention Name(s)

Placebo (for Amoxicillin-clavulanic Acid)

Primary Outcome Measure Information:

Title

The proportion without chronic respiratory symptoms and signs or bronchiectasis.

Description

Time Frame

Clinical review at 24 months (range 23-25 months)

Secondary Outcome Measure Information:

Title

The proportion with clinical cure (i.e. complete resolution of respiratory symptoms and signs).

Description

Time Frame

Clinical review week 4 (range 4-6 weeks)

Title

Time to next respiratory-related hospitalisation assessed by chart reviews

Description

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

Time Frame

Clinical review week 4 (range 4-6 weeks)

Title

Adverse events

Description

Time Frame

Adverse events monitored while participant taking trial medication

Title

Nasopharyngeal bacteria antibiotic resistance patterns

Description

Time Frame

Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months)

Title

Gene expression data

Description

Gene expression micro-arrays will be performed in a subgroup of children (where bloods can be obtained)

Time Frame

Baseline (hospital admission) and 4-6 weeks (where possible)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Chang, PhD

Organizational Affiliation

Menzies School of Health Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Menzies School of Health Research

City

Darwin

State/Province

Northern Territory

ZIP/Postal Code

0812

Country

Australia

Facility Name

Sabah Women and Children's Hospital

City

Kota Kinabalu

State/Province

Sabah

ZIP/Postal Code

88996

Country

Malaysia

Facility Name

Sarawak General Hospital

City

Sibu

State/Province

Sarawak

ZIP/Postal Code

96000

Country

Malaysia

Facility Name

University Malaya Medical Centre and Klang Hospital

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Starship Children's Hospital & KidzFirst Hospital

City

Auckland

ZIP/Postal Code

1142

Country

New Zealand

12. IPD Sharing Statement

Plan to Share IPD

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Hospitalised Pneumonia With Extended Treatment (HOPE) Study

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