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Rapid Viral Diagnostics in Adults to Reduce Antimicrobial Consumption and Duration of Hospitalization

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ClinicalTrials.gov Identifier: NCT02538770
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : January 11, 2016
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu

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 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.


Condition or disease Intervention/treatment Phase
Respiratory Virus Infection Fever of Unknown Origin Dyspnea Chest Pain Other: Rapid diagnostics using Anyplex TMII RV16 Detection Other: Delayed diagnostics Anyplex TMII RV16 Detection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Impact of Respiratory Pathogen PCR Assay on Treatment of Adult Patients: A Randomized Controlled Trial
Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Rapid Anyplex TMII RV16 Detection
Intervention is the rapid performance of Anyplex TMII RV16 detection
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

Active Comparator: Delayed Anyplex TMII RV16 Detection
Comprative intervention is the delayed performance of Anyplex TMII RV16 detection
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




Primary Outcome Measures :
  1. Duration of hospitalization [ Time Frame: One month ]
    The number of days in hospital within one month after randomization

  2. Antimicrobial consumption [ Time Frame: One month ]
    Number of days on antimicrobials within one month after randomization

  3. Antimicrobial consumption [ Time Frame: One month ]
    Defined daily doses of antimicrobial agents within one month after randomization


Secondary Outcome Measures :
  1. Number of radiological examinations [ Time Frame: One month ]
  2. Cost of other examinations in hospital [ Time Frame: One month ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538770


Locations
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Finland
Emergency Room of Oulu University Hospital
Oulu, Finland
Pulmonology ward Oulu University Hospital
Oulu, Finland
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Investigators
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Principal Investigator: Marjo Renko, PhD, MD Oulu University Hospital
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT02538770    
Other Study ID Numbers: PPSHP93/2014
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Dyspnea
Chest Pain
Fever of Unknown Origin
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Pain
Neurologic Manifestations
Fever
Body Temperature Changes