Outpatient antibiotic overuse in acute respiratory infections (ARI) in Children's Hospital No. 1, Viet Nam
ISRCTN | ISRCTN32862422 |
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DOI | https://doi.org/10.1186/ISRCTN32862422 |
Secondary identifying numbers | ctu03avjun08 |
- Submission date
- 16/07/2008
- Registration date
- 17/07/2008
- Last edited
- 05/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
A recent study in the Outpatient Department in Childrens Hospital Nº1, Viet Nam showed that about 85% of outpatients with acute respiratory infections were prescribed antibiotics because more specific (microbiologic) diagnostics usually take too long, and physicians choose to treat all possible treatable diagnoses while waiting for results. Therefore, this study was conducted to collect data that will allow us to make retrospective conclusions on appropriate or inappropriate use of antibiotics, and will help in determining at which pathogen rapid diagnostic tests should be aimed in order to effectively reduce the use of antibiotics by prescribing physicians.
Who can participate?
Children less than 16 years of age presenting to the Outpatient Department in Childrens Hospital Nº1 with acute respiratory infections, not admitted to the hospital and living in Ho Chi Minh city.
What does the study involve?
Nose, throat and rectal swabs and blood, stool and urine samples will be collected, along with information on symptoms and antibiotics used.
What are the possible benefits and risks of participating?
All research investigations will be paid for. In addition, there will be a contribution towards the costs of consumables as well as transport for follow up.
Where is the study run from?
The study is run by researchers at the Oxford University Clinical Research Unit (OUCRU) Viet Nam; and Outpatient Department in Childrens Hospital No1, Ho Chi Minh City, Vietnam.
When is the study starting and how long is it expected to run for?
The study ran from February 2009 to February 2010.
Who is funding the study?
The Wellcome Trust (UK).
Who is the main contact?
The Clinical Trials Unit at the Oxford University Clinical Research Unit Viet Nam
+84 839241983
Contact information
Scientific
The Oxford University Clinical Research Unit (OUCRU)
Hospital for Tropical Diseases
190 Ben Ham Tu
Ho Chi Minh City
Q5
Viet Nam
Phone | +84 8 924 1983 |
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rvandoorn@oucru.org |
Study information
Study design | Prospective descriptive study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Outpatient antibiotic overuse in acute respiratory infections (ARI) in Children's Hospital No. 1, Viet Nam |
Study objectives | The generated data will allow us to make retrospective conclusions on appropriate or inappropriate use of antibiotics, and will help in determining at which pathogen rapid diagnostic tests (Point of Care) should be aimed in order to effectively reduce the use of antibiotics by prescribing physicians. |
Ethics approval(s) | Ethics approval pending as of 16/07/2008 from: 1. Oxford Tropical Medicine Research Ethics Committee (OXTREC) (UK) (ref: 31/08) 2. Childrens Hospital No. 1 (Viet Nam) |
Health condition(s) or problem(s) studied | Acute respiratory infections (ARI) |
Intervention | Specimen collection: 1. 1 nasopharyngeal aspirate (NPA) 2. 1 nose swab 3. 1 throat swab 4. 1 rectal swab 5. Capillary blood (3 drops on filter paper) 6. Urine sample: 10 ml 7. Symptoms and signs 8. Antibiotics used |
Intervention type | Other |
Primary outcome measure | 1. To quantify the inappropriate antibiotic use in outpatient acute respiratory infections in Children's Hospital No. 1, Viet Nam 2. To identify the most common viral and bacterial aetiologies associated with inappropriate antibiotic use |
Secondary outcome measures | 1. To assess epidemiology, aetiology, (pre) treatment, clinical features and outcomes acute respiratory infections in outpatients 2. To assess the short-term effect of antibiotic use on the selection of resistant bacteria in the rectal swabs |
Overall study start date | 01/02/2009 |
Completion date | 01/02/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Upper age limit | 16 Years |
Sex | Both |
Target number of participants | 500 patients |
Total final enrolment | 563 |
Key inclusion criteria | 1. Aged less than 16 years, either sex 2. Diagnosis of acute respiratory infections (ARI) 3. Not admitted to the hospital 4. Informed consent by parents or legal guardians 5. Living in Ho Chi Minh City and agreeing to return for follow up visit after 1 week |
Key exclusion criteria | 1. Having underlying illness (except asthma) 2. Previous admission within 3 months (in any hospital or health centre) 3. No consent given |
Date of first enrolment | 01/02/2009 |
Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Q5
Viet Nam
Sponsor information
University/education
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom
Website | http://www.ox.ac.uk/ |
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https://ror.org/052gg0110 |
Funders
Funder type
Charity
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 04/11/2020 | 05/11/2020 | Yes | No |
Editorial Notes
05/11/2020: Publication reference and total final enrolment number added.