1. To evaluate the burden of disease of CAP and other LRTI in elderly in primary care in terms of duration of symptoms, number of hospitalization and mortality, and number of complications.2. To evaluate the burden of disease of CAP and other LRTI…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: duration of symptoms of CAP and other LRTI.
Secondary outcome
Secondary endpoints: complications of CAP and other LRTI, quality of life and
daily activities, number of infections with Streptococcus pneumoniae, number of
infections with other bacterial pathogens (Haemophilus influenzae, Moraxella
catharralis, Mycoplasma pneumoniae).
Background summary
Respiratory tract infections are among the most common reasons for patients to
visit the GP practice. Lower respiratory tract infections (LRTI) are seen most
often in elderly and increase with age. Pneumonia is associated with a worse
outcome in older adults, which is reflected by high complication or
hospitalization rates and mortality figures. In addition to severe
complications, comorbid disorders and quality of health and daily activity
level can also temporarily be impaired by LRTI, as is demonstrated in hospital
based studies. Only very few data are available on duration of symptoms of LRTI
and its effects on comorbidity and quality of life and daily activities among
elderly in primary care. It is also unknown to what extent co-morbidity
including underlying chronic lung disease does modify the course of lower
respiratory tract infections and related burden of disease.
Streptococcus pneumoniae is the most frequent causative pathogen found in CAP
but exact figures on bacterial frequencies are currently lacking.
With this study we aim to provide insight into the burden of LRTI in the
primary care setting, in terms of duration of symptoms, number of complications
and health related quality of life. In addition, we aim to determine the
proportion of bacterial and in specific pneumococcal infections of total LRTI
in primary care.
Study objective
1. To evaluate the burden of disease of CAP and other LRTI in elderly in
primary care in terms of duration of symptoms, number of hospitalization and
mortality, and number of complications.
2. To evaluate the burden of disease of CAP and other LRTI in elderly in
primary care in terms of daily activities and health-related quality of life.
3. To study the relation between co-morbidity and burden of disease
4. To evaluate the frequency of Streptococcus pneumoniae, Haemophilus
influenzae, Moraxella catharralis and Mycoplasma pneumoniae in elderly in
primary care presenting with a LRTI.
Study design
prospective observational study
Study burden and risks
After subjects have given informed consent, the GP or a research physician will
collect data on symptoms, medical history and comorbidity. In addition a blood
sample, a urine sample, an oropharyngeal swab and if possible a sputum sample
will be collected at the GP practice, local laboratory or at the subject*s
home. Severity of infection will be assessed using the following parameters :
respiratory frequency, heart rate, blood pressure, fever, C-reactive protein
and the clinical diagnosis according to GP diagnosis code and specific
definitions. A sub-analysis of CAP-cases will be made based on the GP*s
clinical diagnosis (ICPC code R81: pneumonia) with the presence of at least 3
signs/symptoms suggestive for pneumonia. Presence of Streptococcus pneumoniae
will be assessed using the Binax urinary antigen test. Presence of bacterial
pathogens will be assessed with one nasopharyngeal and one oropharyngeal swab
for PCR-testing and/or sputum culture. Subjects will be asked on day 1 to fill
in a diary on their symptoms and any need for seeking medical assistance for
the duration of their complaints with a maximum of 4 weeks, On day 1 and then
every week up to 4 weeks subjects fill in a health instrument (EQ-5D) to assess
quality of life and daily activity levels. After 3 months subjects will be
asked to fill in the EQ-5D instrument one more time. Data on hospitalization,
death, and any unscheduled visits to the GP practice or outpatient department
or emergency department of a hospital within 28 days of the start of the LRTI
episode will be collected retrospectively in the subject*s medical file in the
GP practice.
The extra time during consultation in the GP practice will be 5 minutes. The
laboratory home visit will take 10 minutes. A risk of drawing blood is
development of local haematoma which will resolve in a few days. Filling in the
diary will take 2 minutes per day and filling in the questionnaires will take 2
minutes per questionnaire.
Universiteitsweg 100
3584CG Utrecht
NL
Universiteitsweg 100
3584CG Utrecht
NL
Listed location countries
Age
Inclusion criteria
1.Male or female adults aged 50 years or older
2.Registered with a GP who is participating in the study
3.an acute cough lasting for at least 3 days
4.Symptoms/signs suggestive of CAP or other LRTI (see protocol section 2: Definitions)
5.able to fill in a diary
Exclusion criteria
1.Residence in a nursing home, long-term care facility or other institution, with requirement of semiskilled nursing care.
2.Immune deficiency or suppression, defined as presence of immunocompromising disease or chronic use of immunosuppressive drugs (for prednisone low doses are allowed).
3. Hospitalisation within 7 days preceding date of inclusion
4. Severity of illness requiring hospitalisation on date of inclusion
5. Use of systemic antibiotic drugs within 14 days preceding date of inclusion
See protocol paragraph 5.3 Exclusion criteria
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 | NL34289.041.10 |