Hospitalised Pneumonia With Extended Treatment (HOPE) Study

Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02783859
• Other study ID #: HOPE_V5_01022017
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 314
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Amoxicillin-clavulanic Acid

• Placebo (for Amoxicillin-clavulanic Acid)

Locations

Country	Name	City	State
Australia	Menzies School of Health Research	Darwin	Northern Territory
Malaysia	Sabah Women and Children's Hospital	Kota Kinabalu	Sabah
Malaysia	University Malaya Medical Centre and Klang Hospital	Kuala Lumpur
Malaysia	Sarawak General Hospital	Sibu	Sarawak
New Zealand	Starship Children's Hospital & KidzFirst Hospital	Auckland

Sponsors (7)

Lead Sponsor	Collaborator
Menzies School of Health Research	Griffith University, Nanyang Technological University, Queensland University of Technology, Sarawak General Hospital, The University of Queensland, University of Malaya

Countries where clinical trial is conducted

Australia,  Malaysia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Clinical review at 24 months (range 23-25 months)
Secondary	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.	Clinical review week 4 (range 4-6 weeks)
Secondary	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	Clinical review week 4 (range 4-6 weeks)
Secondary	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.	Adverse events monitored while participant taking trial medication
Secondary	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.	Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months)
Secondary	Gene expression data	Gene expression micro-arrays will be performed in a subgroup of children (where bloods can be obtained)	Baseline (hospital admission) and 4-6 weeks (where possible)