Outpatient antibiotic overuse in acute respiratory infections (ARI) in Children's Hospital No. 1, Viet Nam

ISRCTN	ISRCTN32862422
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Rogier van Doorn
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
Email	rvandoorn@oucru.org

Study information

Study design	Prospective descriptive study
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
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

The Oxford University Clinical Research Unit (OUCRU)

Ho Chi Minh City
Q5
Viet Nam

Sponsor information

University of Oxford (UK)
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/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 077078)

No information available

Results and Publications

Intention to publish date
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?
Results article	results	04/11/2020	05/11/2020	Yes	No

Editorial Notes

05/11/2020: Publication reference and total final enrolment number added.