Determine asymptomatic nasopharyngeal pneumococcal carriage and serotype distribution in elderly aged 65-70 years, 71-80 years ald 80 years and older. Assessment of the value of PCR compared with conventional culture methods.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pneumococcal carriage rates will be determined in at least 100 elderly per age
category (aged 65-70 years, 71-79 years and 80 years and older).
Rates of pneumococcal nasopharyngeal carriage by conventional culture methods
and Polymerase Chain Reaction (PCR) will be compared.
Secondary outcome
Influence of exposure to other people (particularly children) will be explored
via questionnaires.
Background summary
Respiratory and invasive pneumococal infections are an important cause of
morbidity and mortality among elderly, particularly pneumonia. With age, the
contribution of the pediatric serotypes increases. However, data on
asymptomatic nasopharyngeal carriage prevalence and serotype distribution in
elderly are scarce. The value of PCR analysis may enhance sensitivity compared
with conventional culture methods.
Study objective
Determine asymptomatic nasopharyngeal pneumococcal carriage and serotype
distribution in elderly aged 65-70 years, 71-80 years ald 80 years and older.
Assessment of the value of PCR compared with conventional culture methods.
Study design
Elderly of 65 years and older who are eligible for the annual influneza
vaccination, will be selected for the carriage prevalence study by the GP and
invited to participate via the primary care physician.
The study subjects will visited at home once for the collection of 2 transnasal
and 2 transoral swabs. A questionnaire by the research nurse or physiocian will
collect data on related to risk factors for pneumococcal carriage (health,
environment, life style and contacts with young children).
The study outcome will be descriptive. To detect at least 7% carriage with 90%
power and alfa of 5% , 300 elderly persons are needed. A drop out rate of 10%
is expected; therefore 110 subjects per age group will be included in order to
have 100 evaluable subjects per age group.
The project is a collaboration of the Wilhelmina Children*s Hospital and the
Julius Center of the UMC Utrecht together with the Spaarne Hospital in
Hoofddorp and the GPs in the Hoofddorp/Nieuw Vennep region.
Study burden and risks
One home visit of approximately 45 minutes. The risk of non-severe and self
limiting nose bleeding is less tha 1:1000 (according to studies in infants)
Universiteitsweg 100
3584 CG Utrecht
Nederland
Universiteitsweg 100
3584 CG Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
1. Persons aged 65 years and older
2. Obtained written informed consent
Exclusion criteria
1. Persons in healthcare institutions or nursing homes (in The Netherlands these persons are not listed at the GP practice);
2. Patients who can not fulfil study procedures according to the GP;
3. The use of experimental trial medication within 30 days preceding the pre-study;
4. The use of antibiotics within 30 days preceding the pre-study;
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 | NL18519.041.07 |