The objective of the standardized protocol is optimalizing the accuracy of the diagnosis (all-cause pneumonia, or serotype-specific pneumonia) during the 13-valent pneumococcal vaccin (13vPnC) study which will be performed in 2008. Additionaly, the…
ID
Source
Brief title
Condition
- Helminthic disorders
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Optimalization of the diagnostic protocol in adults admitted with suspected
pneumonia. Outcome is the adherence to the proposed protocol (which is
internationally consider optimal). The aim is a compliance of >95%.
Secondary outcome
Determination of specificity and additional diagnostic value of the new
diagnostic tests in blood and urine. The outcome is specificity and the aim is
100%.
Background summary
The standard diagnostic protocol for patients with suspected lower respiratory
tract infection (including pneumonia) includes medical history taking, physical
examination, and laboratory and microbiological testing. It is widely accepted
that antimicrobial therapy should be targetted to the causative microorganism.
Nevertheless, sensitivity of current microbiological tests is low. In over 50%
of cases, the causative micro-organism is not found
According tot the 'the Infectious Disease Society of America' (2007)
guidelines, cultures of blood and sputum, and urine antigen testing for
Legionella and S.Pneumonia should be performed in all patients admitted with
suspected pneumonia. Also, analysis of blood samples (hematological and
biochemical) and interpretation of a chest x-ray should be performed.
The proposed study evaluates the implementation of a standardized diagnostic
protocol (including all of the above), with the addition of two new diagnostic
tests (in blood and urine) for patients admitted with suspected pneumonia.
Study objective
The objective of the standardized protocol is optimalizing the accuracy of the
diagnosis (all-cause pneumonia, or serotype-specific pneumonia) during the
13-valent pneumococcal vaccin (13vPnC) study which will be performed in 2008.
Additionaly, the added diagnostic value of the two new techniques (blood and
urine testing) for detection of S. Pneumonia will be studied.
Study design
On admission, an extra vial (10 ml blood) will be taken during routine
bloodsampling. An additional sample (25 ml urine) will be taken during routine
urinesampling. Within 24-48 hours after admission, informed consent will be
asked to use these materials for diagnostic research. If no consent is given,
the materials will be destroyed.
When informed consent is given for participation in the study, the materials
will be analysed in the central laboratory.
Study burden and risks
Burden: 10 ml extra blood is taken
Risks: no extra risks
Universiteitsweg 100
3584 CG Utrecht
NL
Universiteitsweg 100
3584 CG Utrecht
NL
Listed location countries
Age
Inclusion criteria
1) Admission with suspected Community Acquired Pneumonia
2) Age: adult (18 years and older)
3) Informed consent
Exclusion criteria
1. Recent admission (<2 weeks), or living in nursing home
2. History of bronchial obstruction or postobstruction pneumonia. Patients with COPD will not be excluded.
3. History of lungcancer or pulmonary metastases
4. AIDS, known or suspected pneumonia caused by Pneumocystis Carinii or known or suspected active tuberculosis.
5. Unability to give informed consent.
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 | NL18747.041.07 |