PneumoniaPhase 4HOPENCT02783859
Hospitalised Pneumonia With Extended Treatment (HOPE) Study
A Phase 4 study testing Amoxicillin-clavulanic Acid in people with Pneumonia, run by Menzies School of Health Research at 5 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Amoxicillin-clavulanic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jun 2016to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Malaysia3 sites
Sabah Women and Children's Hospital
Kota Kinabalu, Sabah, 88996
University Malaya Medical Centre and Klang Hospital
Kuala Lumpur, Kuala Lumpur, 59100
Sarawak General Hospital
Sibu, Sarawak, 96000
Australia1 site
Menzies School of Health Research
Darwin, Northern Territory, 0812
New Zealand1 site
Starship Children's Hospital & KidzFirst Hospital
Auckland, Auckland, 1142
About this 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
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
Read the 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
- Conditions
- Pneumonia
- Being tested
- Amoxicillin-clavulanic Acid, Placebo (for Amoxicillin-clavulanic Acid)
- Keywords
- Children, Anti-Bacterial Agents, Indigenous Population, Hospitals
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-clavulanic AcidDrug
Placebo (for Amoxicillin-clavulanic Acid)Drug
| Study group | Role | What they receive |
|---|---|---|
| Active arm: Amoxicillin-clavulanic Acid | Experimental | 8 days of oral amoxicillin-clavulanic Acid 400/57 duo formulation (70-90mg/kg/day, twice daily dosing: max 980mg per day) Receives: Drug: Amoxicillin-clavulanic Acid |
| Placebo arm | Placebo comparator | 8 days of oral placebo (equivalent volume as the active arm) Receives: Drug: Placebo (for Amoxicillin-clavulanic Acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Clinical review at 24 months (range 23-25 months)
Secondary outcomes (5)
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.
Measured: Clinical review week 4 (range 4-6 weeks)
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
Measured: Clinical review week 4 (range 4-6 weeks)
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.
Measured: Adverse events monitored while participant taking trial medication
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.
Measured: Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months)
Gene expression data
Gene expression micro-arrays will be performed in a subgroup of children (where bloods can be obtained)
Measured: Baseline (hospital admission) and 4-6 weeks (where possible)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Griffith University, Sarawak General Hospital, University of Malaya, The University of Queensland, Queensland University of Technology, Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Anne Chang, PhD, Principal investigator, Menzies School of Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783859
- Sponsor's protocol ID
- HOPE_V5_01022017
- Acronym
- HOPE
- Status last verified
- Jan 2026
- First submitted
- 5 May 2016
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02783859
- Acronym / sponsor ID
- HOPE / HOPE_V5_01022017
- Conditions
- Pneumonia
- Keywords
- Children, Anti-Bacterial Agents, Indigenous Population, Hospitals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Griffith University, Sarawak General Hospital, University of Malaya, The University of Queensland, Queensland University of Technology, Nanyang Technological University
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm: Amoxicillin-clavulanic Acid | Experimental | Drug: Amoxicillin-clavulanic Acid8 days of oral amoxicillin-clavulanic Acid 400/57 duo formulation (70-90mg/kg/day, twice daily dosing: max 980mg per day) |
| Placebo arm | Placebo comparator | Drug: Placebo (for Amoxicillin-clavulanic Acid)8 days of oral placebo (equivalent volume as the active arm) |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin-clavulanic Acid | Drug | Active arm: Amoxicillin-clavulanic Acid |
| Placebo (for Amoxicillin-clavulanic Acid) | Drug | Placebo arm |
Primary outcome
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.
5 secondary outcomes
The proportion with clinical cure (i.e. complete resolution of respiratory symptoms and signs).
Time frame: Clinical review week 4 (range 4-6 weeks)
Time to next respiratory-related hospitalisation assessed by chart reviews
Time frame: Clinical review week 4 (range 4-6 weeks)
Adverse events
Time frame: Adverse events monitored while participant taking trial medication
Nasopharyngeal bacteria antibiotic resistance patterns
Time frame: Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months)
Gene expression data
Time frame: Baseline (hospital admission) and 4-6 weeks (where possible)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Chang, PhD principal investigator
Menzies School of Health Research
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin-clavulanic Acid in people with Pneumonia, run by Menzies School of Health Research at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Malaysia, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion without chronic respiratory symptoms and signs or bronchiectasis. (time frame: Clinical review at 24 months (range 23-25 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.