Rapid Viral Diagnostics in Adults to Reduce Antimicrobial Consumption and Duration of Hospitalization
NCT02538770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900
Last updated 2016-01-11
Summary
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.
Conditions
- Respiratory Virus Infection
- Fever of Unknown Origin
- Dyspnea
- Chest Pain
Interventions
- OTHER
-
Rapid diagnostics using Anyplex TMII RV16 Detection
Rapid diagnostics using Anyplex TMII RV16 Detection, i.e. physician receives results of respiratory virus PCR as soon as they are available
- OTHER
-
Delayed diagnostics Anyplex TMII RV16 Detection
Delayed diagnostics Anyplex TMII RV16 Detection, i.e. physician receives results of respiratory virus PCR after one week delay unless specifically solicited
Sponsors & Collaborators
-
Oulu University Hospital
collaborator OTHER -
University of Oulu
lead OTHER
Principal Investigators
-
Marjo Renko, PhD, MD · Oulu University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2015-11-30
- Completion
- 2015-11-30
Countries
- Finland
Study Locations
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