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

NCT02538770 | Completed

• 1 other identifier: PPSHP93/2014
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Virus Infection; Fever of Unknown Origin; Dyspnea; Chest Pain

Outcome Measures

Primary Outcomes (3)

• Duration of hospitalization

  The number of days in hospital within one month after randomization

  One month

• Antimicrobial consumption

  Number of days on antimicrobials within one month after randomization

  One month

• Antimicrobial consumption

  Defined daily doses of antimicrobial agents within one month after randomization

  One month

Secondary Outcomes (2)

• Number of radiological examinations

  One month

• Cost of other examinations in hospital

  One month

Study Arms (2)

Rapid Anyplex TMII RV16 Detection

EXPERIMENTAL

Intervention is the rapid performance of Anyplex TMII RV16 detection

Other: Rapid diagnostics using Anyplex TMII RV16 Detection

Delayed Anyplex TMII RV16 Detection

ACTIVE COMPARATOR

Comprative intervention is the delayed performance of Anyplex TMII RV16 detection

Other: Delayed diagnostics Anyplex TMII RV16 Detection

Interventions

Rapid diagnostics using Anyplex TMII RV16 Detection OTHER

Rapid diagnostics using Anyplex TMII RV16 Detection, i.e. physician receives results of respiratory virus PCR as soon as they are available

Rapid Anyplex TMII RV16 Detection

Delayed diagnostics Anyplex TMII RV16 Detection OTHER

Delayed diagnostics Anyplex TMII RV16 Detection, i.e. physician receives results of respiratory virus PCR after one week delay unless specifically solicited

Delayed Anyplex TMII RV16 Detection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator

Study Sites (2)

Emergency Room of Oulu University Hospital

Oulu, Finland

Location

Pulmonology ward Oulu University Hospital

Oulu, Finland

Location

MeSH Terms

Conditions

Fever of Unknown Origin; Dyspnea; Chest Pain

Condition Hierarchy (Ancestors)

Fever; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Pain; Neurologic Manifestations

Study Officials

• Marjo Renko, PhD, MD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

FI (2)