Influenza Clinical Trial
Official title:
Influenza Therapeutic Trial: A Pilot Randomized Controlled Trial for Feasibility of Enrolling Subjects for Influenza Therapeutic Trials and Administering Influenza Antivirals in the Emergency Department to High Risk Subjects
This pilot study is designed to demonstrate the feasibility of utilizing Emergency
Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating
influenza therapeutics, and to provide pilot data for future clinical trial design and
planning.
Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed
influenza into a randomized, open label study of oral versus IV influenza therapeutic to
include symptom evaluation and outcome assessments.
Secondary Objective 1: To identify influenza positive patients utilizing a previously
established triage-based assessment and rapid testing algorithm for suspected influenza
infection.
Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for
potential enrollment biases.
Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected
from ED patients with suspected influenza illness.
Title: A Pilot Randomized Controlled Trial for Feasibility of Enrolling Subjects for
Influenza Therapeutic Trials and Administering Influenza Antivirals in the Emergency
Department to High Risk Subjects
Population: Adults presenting to the emergency department (ED) with laboratory confirmed
influenza who meet Centers for Disease Control and Prevention (CDC) criteria for antiviral
treatment
Informed consent: Written informed consent
Number of Sites: 2 - large, urban, academically-affiliated, US EDs
Study Duration: November 2015 - June 2018
Subject Participation Duration: 4 weeks
Description of Agent or Intervention: Subjects will be randomized to either oral
(oseltamivir) or intravenous (IV) (peramivir) antiviral treatment.
Description of Study Design: This is an open-label randomized controlled clinical trial in
which subjects with influenza are randomized to either oral (oseltamivir) or IV (peramivir)
antiviral treatment.
Estimated Time to Complete Enrollment: Subject enrollment will occur over two influenza
seasons (November 2015 - April 2016 and November 2016 - April 2017) or longer, at the
Principal Investigator's discretion, based on influenza prevalence.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
| Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
| Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
| Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
| Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
| Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
| Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
| Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
| Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
| Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
| Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
| Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
| Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
| Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
| Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
| Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
| Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |