The aim of this pilot study is to improve the diagnosis of respiratory infections in primary health care by evaluating the use of the mariPOC® (ArcDia International, Turku, Finland). The mariPOC® is a simple and rapid POCT for the detection of 9 of…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is the evaluation of the diagnostic performance of the
mariPOC® respi test in a primary health care setting. Sensitivity,
specificity, positive predictive value, negative predictive value will be
calculated separately for each agent regardless of detection of more agents in
samples.
Secondary outcome
The secondary study parameter is the feasibility and value of this POCT in
general practice. This will be evaluated by interviewing the health care
professionals (GPs, assistants) according to structured questionnaires.
Besides, with the results of this study we are able to increase our insight in
the prevalence of the different respiratory viruses in primary care.
Background summary
Respiratory tract infections are the second most common cause of morbidity and
mortality worldwide and the commonest acute problem dealt with in primary care.
RTIs are mainly of viral etiology and common respiratory viruses include
influenza A and B viruses, respiratory syncytial virus, adenovirus,
parainfluenza virus types 1, 2, and 3, and rhinovirus. Rapid, sensitive and
specific identification of causative pathogens of RTIs assists diagnostic
interpretation by the general practitioner and might prevent inappropriate use
of antibiotics. Point-of-care tests (POCTs) are rapid, easy-to-use tests
carried out near the patient by non-laboratory-trained personnel. As suggested
by several studies a reduction of antibiotic prescriptions could be achieved by
carrying out POCTs in primary care.
The availability of POCTs is increasing and according to several
cost-effectiveness evaluations the use of POCTs leads to a more effective
utilization of healthcare resources. POCTs for the diagnosis of respiratory
tract infections can offer clinicians the ability to manage patients*
expectations for antibiotics and to encourage patients to self-care when
suffering from a self-limiting condition.
However, the diagnostic performance of POCTs is only sporadically evaluated in
clinical settings. Most of the publications regarding POCTs are retrospective
studies or studies where the test is used in a laboratory setting. Results can
therefore not be extrapolated to daily clinical practice. Because of the
potentially promising influence of POCTs on patient care, well designed
clinical validation studies are needed.
Study objective
The aim of this pilot study is to improve the diagnosis of respiratory
infections in primary health care by evaluating the use of the mariPOC® (ArcDia
International, Turku, Finland). The mariPOC® is a simple and rapid POCT for the
detection of 9 of the most frequently occurring respiratory viruses (influenza
A/B, respiratory syncytial virus, parainfluenza 1, 2, and 3, human bocavirus,
human metapneumovirus (hMPV), and adenoviruses) from a single nasopharyngeal
sample.
Study design
The design of this pilot study will be an open prospective evaluation study.
The study will be conducted in the respiratory season and the duration of the
study is five months (October 2015 till March 2016). The setting will be a
primary health care practice at Health Center Gein, Wisseloordplein 50, 1106 MH
Amsterdam. In this center about 11.000 patients are enlisted with 7 general
practitioners. The center cooperates as a partner within the academic network
for over 15 years.
Study burden and risks
One nasopharyngeal swab will be collected from all patients presenting with
respiratory tract symptoms. The participants will be asked to fill in a small
questionnaire about their symptoms. Information on demographic and clinical
characteristics will be obtained from medical records and summarized in a
standardized record form. To our knowledge, no risks are associated with the
collection of a nasopharyngeal swab.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients of all ages with a clinical suspicion of a respiratory tract infection (at least one of the following respiratory illness symptoms: common cold, rhinorroea, cough, wheeze, fever> 37.5 degrees Celsius)
Exclusion criteria
Presence of contraindications for collecting a nasopharyngeal swab (e.g. trauma, facial surgery, known platelet disorder)
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 |
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CCMO | NL54043.018.15 |