Condition category
Respiratory
Date applied
16/07/2008
Date assigned
17/07/2008
Last edited
15/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rogier van Doorn

ORCID ID

Contact details

The Oxford University Clinical Research Unit (OUCRU)
Hospital for Tropical Diseases
190 Ben Ham Tu
Ho Chi Minh City
Q5
Viet Nam
+84 8 924 1983
rvandoorn@oucru.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ctu03avjun08

Study information

Scientific title

Acronym

Study hypothesis

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

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)

Study design

Prospective descriptive study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2009

Overall trial end date

01/02/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

500 patients

Participant exclusion criteria

1. Having underlying illness (except asthma)
2. Previous admission within 3 months (in any hospital or health centre)
3. No consent given

Recruitment start date

01/02/2009

Recruitment end date

01/02/2010

Locations

Countries of recruitment

Viet Nam

Trial participating centre

The Oxford University Clinical Research Unit (OUCRU)
Ho Chi Minh City
Q5
Viet Nam

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes