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

NCT02964871 | Completed DMC

• 3 other identifiers: 2016-1160A532000SMPH\FAMILY MEDICINE
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza, Human; Pneumonia

Keywords

Long-term care facility; Elderly

Outcome Measures

Primary Outcomes (5)

• Number of influenza antiviral treatment courses provided during the 4-month influenza seasons in RAPID-LTCF vs. control LTCF

  Oseltamivir is the most commonly used antiviral for influenza treatment. The usual dose is 75 mg twice a day for 5 days.

  4 months

• Number of influenza antiviral prophylaxis courses provided during the 4-month influenza season in RAPID-LTCF vs. control LTCF

  Oseltamivir is the most commonly used antiviral for influenza prophylaxis. The usual dose is 75 mg daily for the duration of likely exposure

  4 months

• Number of respiratory infection-related hospitalizations in RAPID-LTCF vs control LTCF during the 4-month influenza season

  These will include all hospitalizations that include a discharge diagnosis for any respiratory infection.

  4 months

• Number of all-cause hospitalizations in RAPID-LTCF vs. control LTCF during the 4-month influenza season

  All transfers of patients to the hospital will be assessed.

  4 months

• Deaths during the 4-month influenza season in RAPID-LTCF vs. control LTCF

  4 months

Study Arms (2)

LTCF with RIDT

ACTIVE COMPARATOR

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

LTCF Control

PLACEBO COMPARATOR

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

Interventions

Sofia Fluorescent Immunoassay Analyzer Influenza A+B DEVICE

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.

LTCF with RIDT

Usual care OTHER

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.

LTCF Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

MeSH Terms

Conditions

Influenza, Human; Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Jon Temte, MD PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2016
• Primary Completion: June 8, 2019
• Study Completion: October 31, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06