The objective is determine the correlation between the outcome of the cultures of the nasopharyngeal swab, the nose swab, the swab from a handkerchief and the handkerchief.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The concordance and disconcordance between the culture results of the different
sampling methods.
Secondary outcome
The differences in the observational Visual Analogue Scale scores between the
different sampling methods.
Background summary
The nasopharyngeal swab is the gold standard for culturing pathogens involved
in upper respiratory tract infections. Since children may experience this
method as unpleasant (especially when performed repeatedly), we will study the
accuracy of alternative culturing methods. We hope that the results of this
study will allow us to replace the nasopharyngeal culture by one of the less
unpleasant alternatives.
Study objective
The objective is determine the correlation between the outcome of the cultures
of the nasopharyngeal swab, the nose swab, the swab from a handkerchief and the
handkerchief.
Study design
A cross sectional study, during 6 months. The culture methods in randomized
order are: 1. nasal swab, 2. blowing/whiping the nose, swab of the handkerchief
3. blowing/whiping of the nose, culture form handkerchief directly, 4.
nasopharyngeal swab. Bacterial cultures for S. pneumoniae (including
serotyping), H. influenzae, M. catarrhalis and S.aureus will be performed.
Parents will fill in a short questionnaire and an observational Visual Analogue
Scale.
Study burden and risks
We believe that the risk of this study is negligible, for the gold standard is
generally accepted as safe and we plan on testing additional and even less
unpleasant methods in parallel. The nasopharyngeal swab can give an unpleasant
tickly feeling, cough and watery eyes. In rare cases a nose bleed can occur.
Especially when the nasopharyngeal swab is taken repeatedly, the child may find
this unpleasant. For this study only one nasopharyngeal swab has to be taken.
This study is necessary to be able to replace the nasopharyngeal swab in the
future for a reliable and well accepted test.
Lundlaan 6
3584 EA Utrecht
Nederland
Lundlaan 6
3584 EA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- age 0 - 4 years
- a runny nose as a symptom of an upper respiratory tract infection
Exclusion criteria
- age 4 years and older
- antimicrobial therapy in the last 2 weeks
- earlier participation in this study
- medical conditions preventing the child from attending a regular day care centre
- craniofacial abnormalities and cleft palate
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30885.041.09 |