Clinical Trial: Rapid Viral Diagnostics in Adults to Reduce Antimicrobial Consumption and Duration of Hospitalization
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Impact of Respiratory Pathogen PCR Assay on Treatment of Adult Patients: A Randomized Controlled Trial
Brief 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 1
Detailed Summary:
Aim and Hypothesis
The aim of the study is:
- To find out how the modern rapid multiplex-PCR based respiratory virus detection method affects the patient care
- To examine does it shorten the length of admission and reduce antibiotic consumption
- Compare the seasonality of different viruses in children and adults
- Investigate the development and progress of an epidemic
- Study the differences in the prevalence and severity of infections between genders
- Describe clinical manifestations of different viral infections in adults
- View more closely certain subgroups such as patients with chest pain in respect to different viral epidemics and their effect on the hospital admission rates
- Evaluate the information provided by the bacterial detection
Subjects Our hospital is both a regional and a university hospital at the same time. Patients come to our clinic from a quite large area surrounding the city of Oulu and they represent the general population of the area well. The study population will be recruited 2014-2015 in the emergency clinics for pediatric and internal medicine patients in the Oulu University Hospital. Participants are patients with respiratory infection symptoms, chest pain or fever. Fever is determined as body temperature of 38 degrees centigrade or more measured either in the hospital or at home.
Study design This is a randomized clinical trial evaluating the impact of modern multiplex PCR based respiratory virus diagnostics on treatment and ou
Sponsor: University of Oulu
Current Primary Outcome:
- Duration of hospitalization [ Time Frame: One month ]The number of days in hospital within one month after randomization
- Antimicrobial consumption [ Time Frame: One month ]Number of days on antimicrobials within one month after randomization
- Antimicrobial consumption [ Time Frame: One month ]Defined daily doses of antimicrobial agents within one month after randomization
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of radiological examinations [ Time Frame: One month ]
- Cost of other examinations in hospital [ Time Frame: One month ]
Original Secondary Outcome: Same as current
Information By: University of Oulu
Dates:
Date Received: August 31, 2015
Date Started: September 2014
Date Completion:
Last Updated: January 8, 2016
Last Verified: January 2016
