Hospitalised Pneumonia With Extended Treatment (HOPE) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2022-12-31

Brief Summary

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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

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Detailed Description

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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

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Amoxicillin-clavulanic Acid

Intervention Type DRUG

Placebo arm

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

Group Type PLACEBO_COMPARATOR

Placebo (for Amoxicillin-clavulanic Acid)

Intervention Type DRUG

Interventions

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Amoxicillin-clavulanic Acid

Intervention Type DRUG

Placebo (for Amoxicillin-clavulanic Acid)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No