Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000958684
Ethics application status
Approved
Date submitted
24/08/2014
Date registered
8/09/2014
Date last updated
13/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study on length of antibiotics for children hospitalized with pneumonia
Scientific title
Does a longer course (13-14 days) of antibiotics compared to a shorter course (5-6 days), improve short and medium-term clinical outcomes of children hospitalised with severe community-acquired pneumonia
Secondary ID [1] 285215 0
None
Universal Trial Number (UTN)
Trial acronym
HOP-Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia in children 292835 0
Condition category
Condition code
Respiratory 293135 293135 0 0
Other respiratory disorders / diseases
Infection 293136 293136 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Twice daily oral amoxycillin-clavulanic acid (22.5 mg/kg/dose) for 11 days
Arm 2: Twice daily oral amoxycillin-clavulanic acid (22.5 mg/kg/dose) for 3 days followed by oral placebo for 8 days

These treatments are administered after 48-72 hours of IV penicillin/ampicillin, the children are afebrile, with improved respiratory symptoms and signs, SpO2 >92% in air and are ready to be switched to oral antibiotics
Intervention code [1] 290090 0
Treatment: Drugs
Comparator / control treatment
All children receives at least 5 days of antibiotics (at least 2 days of IV plus 3 days oral). The control group receives placebo for the duration on the intervention period (8 days) whilst the active group continues on amoxycillin-clavulanic acid for the intervention period. Both medications for the study are in suspension form and the placebo has been specifically manufactured by the Institute of Drug Therapy (Melbourne, Australia) which has the same taste, appearance and smell.
Control group
Placebo

Outcomes
Primary outcome [1] 292998 0
Presence of cough reported by parents and documented on a diary card
Timepoint [1] 292998 0
Day 21 post commencement of oral antibiotics
Secondary outcome [1] 310104 0
Parent proxy-chronic cough Quality of Life (8 items) (PC-QOL-8)
Timepoint [1] 310104 0
Day 21 post commencement of oral antibiotics
Secondary outcome [2] 310105 0
C-reactive protein in the blood
Timepoint [2] 310105 0
Day 21 post commencement of oral antibiotics

Eligibility
Key inclusion criteria
(a) Hospitalised children who have been unwell for <7-days with pneumonia
(b) Alveolar consolidation on CXR; and
(c) After 48-72 hours of IV penicillin/ampicillin the children are afebrile, with improved respiratory symptoms and signs, SpO2 >92% in air and are ready to be switched to oral antibiotics
Minimum age
3 Months
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of one or more:
(a) underlying chronic illness (not asthma): chronic lung disease of infancy, bronchiectasis, cystic fibrosis, congenital heart disease, or immunodeficiency
(b) complicated pneumonia (effusion, empyema, abscess); non-alveolar pneumonia; those requiring assisted ventilation or circulatory support; or where a treatment course of IV antibiotics other than penicillin/ampicillin has been used (eg. anti-staphylococcal antibiotics, cephalosporins or macrolides);
(c) extra-pulmonary infection requiring antibiotic therapy (eg. meningitis); or
(d) beta-lactam antibiotic allergy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequential allocation list with each next position concealed by opaque covering.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
This is a pilot study to assess safety and acceptability
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
1. Description of acceptability to families (number)
2. The proportion of children with resolution of the respiratory Symptoms between groups compared using risk ratio
3. Group difference of median PC-QOL and CRP using Mann–Whitney test

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 2911 0
Royal Darwin Hospital - Tiwi

Funding & Sponsors
Funding source category [1] 289830 0
Self funded/Unfunded
Name [1] 289830 0
Country [1] 289830 0
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Royal Darwin Hospital
Rocklands Road
Tiwi, NT 0811
Country
Australia
Secondary sponsor category [1] 288520 0
Individual
Name [1] 288520 0
Professor Anne Chang
Address [1] 288520 0
Children's Health Services (Royal Children's Hospital)
Herston Rd Herston QLD 4029
Country [1] 288520 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291562 0
Human Research Ethics Committee of Northern Territory
Ethics committee address [1] 291562 0
John Matthew Building
Royal Darwin Hospital Campus,
PO Box 41096,
Casuarina NT 0811.
Ethics committee country [1] 291562 0
Australia
Date submitted for ethics approval [1] 291562 0
26/09/2014
Approval date [1] 291562 0
03/11/2014
Ethics approval number [1] 291562 0
Northern Territory Dept of Health and Menzies school of Health Research HREC no. 2014-2273

Summary
Brief summary
This pilot study is to define the acceptability of short vs. long course of antibiotics for the treatment of young children hospitalized with pneumonia
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50890 0
Prof Anne Chang
Address 50890 0
Children's Health Services (Royal Children's Hospital)
Herston Rd
Herston, Brisbane
QLD 4029
Country 50890 0
Australia
Phone 50890 0
+617 36468111
Fax 50890 0
Email 50890 0
[email protected]
Contact person for public queries
Name 50891 0
Prof Anne Chang
Address 50891 0
Children's Health Services (Royal Children's Hospital)
Herston Rd
Herston, Brisbane
QLD 4029
Country 50891 0
Australia
Phone 50891 0
+617 36468111
Fax 50891 0
Email 50891 0
[email protected]
Contact person for scientific queries
Name 50892 0
Prof Anne Chang
Address 50892 0
Children's Health Services (Royal Children's Hospital)
Herston Rd
Herston, Brisbane
QLD 4029
Country 50892 0
Australia
Phone 50892 0
+617 36468111
Fax 50892 0
Email 50892 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3979Plain language summaryNo Not relevant

Documents added automatically
No additional documents have been identified.