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Rapid Assessment of and Prophylaxis for Influenza in Dwellers of Long-term Care Facilities (Rapid-LTCF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02964871
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
RAPID-LTCF is a stratified, block-randomized controlled trial to assess the effectiveness of a simple ARI case definition, rapid influenza diagnostic test (RIDT) with wireless transmission of results, and provision of infection control guidance when influenza is detected. Because of the nature of the intervention, blinding is not possible. Sites will be initially recruited for a study of "respiratory infections within LTCFs." After acceptance into the study, sites will be matched in terms of bed capacity, location, and other features prior to randomization.

Condition or disease Intervention/treatment Phase
Influenza, Human Pneumonia Device: Sofia Fluorescent Immunoassay Analyzer Influenza A+B Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Assessment of and Prophylaxis for Influenza in Dwellers of Long-term Care Facilities
Actual Study Start Date : November 2016
Actual Primary Completion Date : June 8, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: LTCF with RIDT
Nasal swabs will be tested by nursing personnel at each intervention site using SOFIA Fluorescent Immunoassay Analyzer Influenza A+B (LTCF with RIDT). Anonymous results will be sent, via wireless transmission, for daily review by the study team and public health personnel. A positive influenza detection will trigger direct communication with LTCF personnel with advice on antiviral treatment, antiviral prophylaxis, and appropriate infection control practices. We will collect data from each site regarding the prescribing of influenza antivirals for treatment and prophylaxis, number of hospitalizations, number of deaths, and associated healthcare costs during annual, dynamic, 4-month risk windows, based on Wisconsin surveillance of influenza patterns.
Device: Sofia Fluorescent Immunoassay Analyzer Influenza A+B
The Sofia Influenza A+B Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect influenza A and influenza B viral nucleoprotein antigens.

Placebo Comparator: LTCF Control

Usual care.

Data will be collected from each site regarding the prescribing of influenza antivirals for treatment and prophylaxis, number of hospitalizations, number of deaths, and associated healthcare costs during annual, dynamic, 4-month risk windows, based on Wisconsin surveillance of influenza patterns.

Other: Usual care
Our team will discuss our interest in monitoring influenza antiviral treatment and prophylaxis courses, antibiotic courses, clinician and emergency room visits, respiratory infection-related hospitalizations, all-cause hospitalizations, and deaths during the anticipated 4-month influenza season over 3 years.




Primary Outcome Measures :
  1. Number of influenza antiviral treatment courses provided during the 4-month influenza seasons in RAPID-LTCF vs. control LTCF [ Time Frame: 4 months ]
    Oseltamivir is the most commonly used antiviral for influenza treatment. The usual dose is 75 mg twice a day for 5 days.

  2. Number of influenza antiviral prophylaxis courses provided during the 4-month influenza season in RAPID-LTCF vs. control LTCF [ Time Frame: 4 months ]
    Oseltamivir is the most commonly used antiviral for influenza prophylaxis. The usual dose is 75 mg daily for the duration of likely exposure

  3. Number of respiratory infection-related hospitalizations in RAPID-LTCF vs control LTCF during the 4-month influenza season [ Time Frame: 4 months ]
    These will include all hospitalizations that include a discharge diagnosis for any respiratory infection.

  4. Number of all-cause hospitalizations in RAPID-LTCF vs. control LTCF during the 4-month influenza season [ Time Frame: 4 months ]
    All transfers of patients to the hospital will be assessed.

  5. Deaths during the 4-month influenza season in RAPID-LTCF vs. control LTCF [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any resident of one of the 10 LTCF intervention facilities with two acute respiratory infection symptoms (rhinorrhea/runny nose, nasal congestion, sore throat, cough or fever).

Exclusion Criteria:

  • None

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): NCT02964871


Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Jon Temte, MD PhD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02964871    
Other Study ID Numbers: 2016-1160
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Long-term care facility
Elderly
Additional relevant MeSH terms:
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Influenza, Human
Pneumonia
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Antiviral Agents
Anti-Infective Agents