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 Children’s 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 Children’s 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 Children’s 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 designProspective descriptive study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOutpatient antibiotic overuse in acute respiratory infections (ARI) in Children's Hospital No. 1, Viet Nam
Study objectivesThe 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) studiedAcute respiratory infections (ARI)
InterventionSpecimen 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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/02/2009
Completion date01/02/2010

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit16 Years
SexBoth
Target number of participants500 patients
Total final enrolment563
Key inclusion criteria1. 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 criteria1. Having underlying illness (except asthma)
2. Previous admission within 3 months (in any hospital or health centre)
3. No consent given
Date of first enrolment01/02/2009
Date of final enrolment01/02/2010

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.