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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02538770 on ClinicalTrials.gov