InfluenCEF Study: Study on the Headache Associated With Influenza Infection (NCT05704335) | Clinical Trial Compass
UnknownNot Applicable
InfluenCEF Study: Study on the Headache Associated With Influenza Infection
Spain100 participantsStarted 2022-12-20
Plain-language summary
The goal of this observational analytic study with a cohort desing is to evaluate the epidemiology, risk factors and clinical phenotype of headache during Influenza infection. The study will be done in collaboration with the Healthcare Sentinel Network of Castile and Leon (Red Centinela Sanitaria de Castilla y León, RCSCYL) and the National Influenza Center of Valladolid (CNGV). First, the historical data of the VIGIRA network of the 2010-2022 flu seasons will be analyzed, assessing the epidemiology and risk factors of headache during Influenza infection; and second, a study with a case series design with prospective follow-up will be carried out for the incident cases of the 2022-2023 and 2023-2024 Influenza seasons, evaluating the clinical phenotype and the duration of the headache.
Who can participate
Age range
18 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
. Confirmed diagnosis of influenza virus infection, using molecular techniques (PCR) or antigen test.
. Age older than 18 years old.
Exclusion criteria
. Critical medical situation that makes impossible the clinical interview and evaluation of clinical symptoms.
. Prior history of dementia or cognitive impairment that makes it difficult to assess patients or describe symptoms.
. Speech or language impairment, or insufficient comprehension of the Spanish language that makes evaluation difficult.
. Deceased during the course of the flu infection before they could be tested.
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
Prevalence of headache as an influenza symptom
Timeframe: During each influenza season, starting on the season 2010 and until the season 2022, an average of 1 year per season
Trial details
NCT IDNCT05704335
SponsorHospital Clínico Universitario de Valladolid