Evaluating Modes of Influenza Transmission 2b Baseline SAR (NCT07342556) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating Modes of Influenza Transmission 2b Baseline SAR
United States80 participantsStarted 2026-01
Plain-language summary
This is a research study to investigate how influenza transmits from person-to-person. Participation as a healthy "Recipient" in this study involves:
* Home semi-quarantine lasting about 14 days during which the participants must wear an N95 in class and take other precautions
* Daily assessments and clinic visits for 14 days
* Spending every weekday evening for about 14 days from around 6 - 10 pm, including a provided dinner, in a controlled environment. There may be additional sessions and different required participation times on weekends
* Exposure to people infected with influenza in the controlled environment
* Three blood draws, at the start, at the end of 14 days, and about a month after the end.
* A follow-up clinic visits one month after the end of home semi-quarantine
* A two-month follow-up phone call. This study may increase the participant's risk of catching influenza.
If the participants get infected during the study, the investigators may:
* Provide the participants with a prescription for antiviral medication or
* Refer the participants for medical care
* Ask the participants to become a Donor and expose other Recipients.
The participants will be compensated for their time and active participation in the study; however, they may not personally benefit from the study. While the participants may receive supportive care for an infection resulting from the study, this is not meant to replace their regular medical care. If the participants become very ill and need referral for medical care, they or their medical insurance will be billed.
If the participants are someone who recently became infected with influenza either through their daily activities or by participating in this study as a Recipient, they are invited to participate in this research study as a Donor and interact with a group of health participants in a controlled environment. Participation in this study as a Donor involves exposing Recipients for at least one and up to five days including:
* Attend exposure events in a controlled environment
* Weekday evenings from around 6-10 pm
* Additional day and evening events on weekends
* Events include a provided dinner
* Daily assessments and clinic visits for 1 to 5 days
* Provide exhaled breath samples for 30 to 60 minutes
* Three blood draws, at the start and end of exposure events, and about a month after the end
* A follow-up clinic visit one month after their last exposure event
* A two-month follow-up phone call
If the participants experience severe symptoms related to their influenza infection, we may:
* Provide the participants with a prescription for antiviral medication or
* Refer the participants for medical care
The participants will be compensated for their time and active participation in the study; however, they may not personally benefit from the study. While the participants may receive supportive care for their influenza infection, this is not meant to replace their regular medical care. If the participants become very ill and need referral for medical care, they or their medical insurance will be billed.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Enrolled in the Recipient Registry (UMD IRB Protocol # 2303473, eligible age ≥18 and ≤49)
. Provides written informed consent, can comply with the planned study procedures, is available for an up to \~14-day home semi-quarantine period, and can attend scheduled exposure events and scheduled follow-up visits.
. Participants must be able to comprehend the study requirements, as evidenced by a score of 100% on the comprehension assessment (repeated tries permitted).
. No significant change (for the worse) in general health history or in concomitant medication use, as compared from their responses collected during screening (Recipient Protocol).
. Live in a private, single occupancy bedroom and agree to take precautions to avoid contracting a respiratory infection outside of the controlled exposure events through a home semi-quarantine prescribed by investigators.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PCR confirmed transmission of influenza virus infection
Timeframe: 1 month
2
Genomic sequencing-confirmed transmission of influenza virus infection
Timeframe: 1 month
3
Culture-confirmed transmission of influenza virus infection
. Agree not to meet with other participants (Recipients or Donors) outside of the programmed exposure events during their participation in the home semi-quarantine.
Exclusion criteria
. Female of childbearing potential who has a positive urine pregnancy test within 24 hours of enrollment in a Recipient Cohort or is breastfeeding or planning to become pregnant within 2 months after enrollment.
. Presence of infection with influenza, SARS-CoV-2, or other respiratory pathogens detected via a multiplex nucleic acid amplification test (e.g., TaqMan Array Card assay) at entry to the transmission trial.
. Within the past 72 hours, presence of influenza-like illness, as defined as fever of ≥100.2°F AND cough or sore throat, in the absence of an alternative cause.
. Receipt of any blood products within the past 2 months.
. Does not agree to provide permission for secondary research use of extra samples collected and stored specimens.
. Habitual smoker 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.)
. Self-reported or known history of alcohol or drug abuse in the past two years and/or illicit drug use within the last 30 days. (Prescribed stimulants for the treatment of ADHD and cannabinoids use do not constitute exclusionary criteria)
. Has an ongoing symptomatic condition for which the individual has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan. (symptomatic condition means for example ongoing chronic fatigue without a diagnosis for symptom.)