COMPLETED

DMID 21-0041; Influenza CVD 59000

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified.

Official Title

Evaluating Modes of Influenza Transmission Through the Conduct of Controlled Human Influenza Virus Infection Transmission Trials (CHIVITTs)

Quick Facts

Study Start:2023-02-20

Study Completion:2024-04-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05666245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Provides written informed consent, able to comply with the planned study procedures, available for between 2 and 5 days stay in the research quarantine unit for the CHIVITT, and have the ability to attend the scheduled follow-up visits. * Subjects must be able to comprehend the study requirements, as evidenced by a score of ≥70% or better on the comprehension assessment (two attempts permitted). * Males and non-pregnant, non-breastfeeding females1 aged ≥18 and ≤59 years of age, at time of initial consent. * Laboratory-confirmed influenza infection within the past 48 hours at time of entry into the exposure event. * Within the past 48 hours at time of entry into the exposure event, onset of influenza-like illness, as defined as fever (measured oral temperature of ≥100.2°F or self-reported fever in the absence of a measured temperature) AND cough or sore throat, or onset of less specific symptoms with a positive molecular test for influenza virus infection * No self-reported or known history of alcohol or drug abuse within the past two years and no illicit drug use within the last 30 days. * Do not have clinically significant medical, psychiatric, and chronic or intermittent health conditions including those listed in Exclusion Criteria. * Does not have an ongoing symptomatic condition for which subject has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan. * Agrees to the collection of specimens for secondary research.	* Female of childbearing potential who is breastfeeding or has positive urine pregnancy test upon admission to the hotel quarantine unit. * Presence of self-reported or medically documented significant medical or psychiatric condition(s)5 * Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short-acting beta agonists, theophylline, ipratropium, biologics. * Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness7. * Including, but not limited to, corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids or other similar or toxic drugs during the preceding 12-month period. Low dose topical and intranasal steroid preparations used for a discrete period are permitted. * Is a habitual smoker8 of tobacco, marijuana, or e-cigarettes per self-report. * Habitual smokers are those who smoke or vape more than four cigarettes, other tobacco products, e-cigarettes or marijuana in a week for more than three months or use an inhaled nicotine or marijuana product more than 3 days a week on average. Edible or patch forms of tobacco or marijuana products do not constitute an exclusion. * Known allergy or intolerance to treatments for influenza and other respiratory infections (including but not limited to acetaminophen/paracetamol). * History of a previous severe allergic reaction to medicines of any kind with generalized urticaria, angioedema, or anaphylaxis. * Presence of co-infection with SARS-CoV-2, as detected via a multiplex nucleic acid amplification test (e.g., Biofire). * Participating in any other interventional clinical research study that has a scheduled intervention 30 days prior to the CHIVITT or 30 after discharge from the research quarantine unit. * Any condition, to include medical and psychiatric conditions, that in the opinion of the Investigator, might interfere with the safety of the subject or the study objectives.

Inclusion Criteria

Exclusion Criteria

* Provides written informed consent, able to comply with the planned study procedures, available for between 2 and 5 days stay in the research quarantine unit for the CHIVITT, and have the ability to attend the scheduled follow-up visits.
* Subjects must be able to comprehend the study requirements, as evidenced by a score of ≥70% or better on the comprehension assessment (two attempts permitted).
* Males and non-pregnant, non-breastfeeding females1 aged ≥18 and ≤59 years of age, at time of initial consent.
* Laboratory-confirmed influenza infection within the past 48 hours at time of entry into the exposure event.
* Within the past 48 hours at time of entry into the exposure event, onset of influenza-like illness, as defined as fever (measured oral temperature of ≥100.2°F or self-reported fever in the absence of a measured temperature) AND cough or sore throat, or onset of less specific symptoms with a positive molecular test for influenza virus infection
* No self-reported or known history of alcohol or drug abuse within the past two years and no illicit drug use within the last 30 days.
* Do not have clinically significant medical, psychiatric, and chronic or intermittent health conditions including those listed in Exclusion Criteria.
* Does not have an ongoing symptomatic condition for which subject has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan.
* Agrees to the collection of specimens for secondary research.

* Female of childbearing potential who is breastfeeding or has positive urine pregnancy test upon admission to the hotel quarantine unit.
* Presence of self-reported or medically documented significant medical or psychiatric condition(s)5
* Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short-acting beta agonists, theophylline, ipratropium, biologics.
* Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness7.
* Including, but not limited to, corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids or other similar or toxic drugs during the preceding 12-month period. Low dose topical and intranasal steroid preparations used for a discrete period are permitted.
* Is a habitual smoker8 of tobacco, marijuana, or e-cigarettes per self-report.
* Habitual smokers are those who smoke or vape more than four cigarettes, other tobacco products, e-cigarettes or marijuana in a week for more than three months or use an inhaled nicotine or marijuana product more than 3 days a week on average. Edible or patch forms of tobacco or marijuana products do not constitute an exclusion.
* Known allergy or intolerance to treatments for influenza and other respiratory infections (including but not limited to acetaminophen/paracetamol).
* History of a previous severe allergic reaction to medicines of any kind with generalized urticaria, angioedema, or anaphylaxis.
* Presence of co-infection with SARS-CoV-2, as detected via a multiplex nucleic acid amplification test (e.g., Biofire).
* Participating in any other interventional clinical research study that has a scheduled intervention 30 days prior to the CHIVITT or 30 after discharge from the research quarantine unit.
* Any condition, to include medical and psychiatric conditions, that in the opinion of the Investigator, might interfere with the safety of the subject or the study objectives.

Contacts and Locations

Study Locations (Sites)

University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health

Baltimore, Maryland, 21201

United States

University of Maryland, College Park School of Public Health

College Park, Maryland, 20742

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-20

Study Completion Date2024-04-17

Study Record Updates

Study Start Date2023-02-20

Study Completion Date2024-04-17

Terms related to this study

Additional Relevant MeSH Terms

Influenza