Hospitalised Pneumonia With Extended Treatment (HOPE) Study

Menzies School of Health Research314 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

314

Conditions

Pneumonia

Interventions

Amoxicillin-clavulanic AcidDRUG

Placebo (for Amoxicillin-clavulanic Acid)DRUG

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (5)

Menzies School of Health Research

Darwin, Northern Territory, Australia

University Malaya Medical Centre and Klang Hospital

Kuala Lumpur, Kuala Lumpur, Malaysia

Sabah Women and Children's Hospital

Kota Kinabalu, Sabah, Malaysia

Sarawak General Hospital

Sibu, Sarawak, Malaysia

Outcomes

Primary Outcomes

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.

Time frame: Clinical review at 24 months (range 23-25 months)

Secondary Outcomes

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 frame: 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

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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