Dyspnea Clinical Trial
Official title:
The Impact of Respiratory Pathogen PCR Assay on Treatment of Adult Patients: A Randomized Controlled Trial
Verified date | January 2016 |
Source | University of Oulu |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
Viral respiratory infections are common and often require use of health care resources.
Patients receive inappropriate bacterial antibiotics, which has many problems including
side-effects, development of resistance and costs.
A small portion of the infections leads to severe clinical manifestations including
hospitalisations and deaths. The significance of influenza virus is well known and it is
actively detected in all age groups. However, the benefits of detecting other respiratory
viruses have mainly been studied among children but not among adults. The development of
multiplex PCR technique has provided a new and sensitive method for diagnosing a large panel
of viruses. To convince the economical benefits of the rapid viral diagnostic in adult
infectious patient, more evidence is needed.
In our randomized study, nasal and pharyngeal samples from the patients evaluated at the
emergency clinic of internal medicine in the University Hospital of Oulu because of any
respiratory symptom, chest pain or fever, will be collected. The samples will be tested for
16 different respiratory viruses by using Anyplex TMII RV16 Detection. The adult
participants will be randomized in two groups. In one group the results of the testing will
be reported for the attending physician as soon as possible, and in the other group 7 days
after sampling. The effect of this delay to patient care is monitored. Also the results of
children and adults are compared as well as results of men and women. The hypothesis is that
rapid viral diagnostics shortens the length of admission and diminishes the use of bacterial
antibiotics. New information on the viral epidemiology among children and adults is provided
and clinical manifestations of specific viral infections in adults are described.
The estimated 1500 samples are also tested for 5 different respiratory bacteria by Anyplex
TM II RB5 Detection. These results will be examined after completion of the study period.
The benefits of rapid bacterial detection are evaluated in respect to the clinical course of
the disease and considering the infection control aspects as well.
Status | Completed |
Enrollment | 900 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - All patients visiting Oulu University Hospital emergency room or admitted to acute pulmonology ward AND signs of possible respiratory tract infection such as cough, fever or dyspnea OR chest pain Exclusion Criteria: - No exclusion criteria |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Finland | Emergency Room of Oulu University Hospital | Oulu | |
Finland | Pulmonology ward Oulu University Hospital | Oulu |
Lead Sponsor | Collaborator |
---|---|
University of Oulu | Oulu University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of hospitalization | The number of days in hospital within one month after randomization | One month | No |
Primary | Antimicrobial consumption | Number of days on antimicrobials within one month after randomization | One month | No |
Primary | Antimicrobial consumption | Defined daily doses of antimicrobial agents within one month after randomization | One month | No |
Secondary | Number of radiological examinations | One month | No | |
Secondary | Cost of other examinations in hospital | One month | No |
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