InfluenCEF Study: Study on the Headache Associated With Influenza Infection

NCT05704335 | Recruiting

• 1 other identifier: PI 22- 2884
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Headache Disorders; Influenza -Like Illness; Head Pain; Migraine; Viral Infection

Keywords

Headache disorders; Secondary headache; Virus diseases; Epidemiology; Influenza

Outcome Measures

Primary Outcomes (1)

• Prevalence of headache as an influenza symptom

  To calculate the proportion of patients who reported headache during the course of influenza infection

  During each influenza season, starting on the season 2010 and until the season 2022, an average of 1 year per season

Secondary Outcomes (7)

• Prevalence of headache as an influenza symptom - prospective

  During the 2022-2024 influenza seasons, an average of 1 year per season

• Predictors of headache as an influenza symptom

  Including data from influenza seasons 2010-2022, an average of 1 year per season

• Predictors of headache as an influenza symptom - prospective

  During the 2022-2024 influenza seasons, an average of 1 year per season

• Impact of headache in the prognosis of influenza

  Including data from influenza seasons 2010-2022, an average of 1 year per season

• Impact of headache in the prognosis of influenza - prospective

  During the 2022-2024 influenza seasons, an average of 1 year per season

Other Outcomes (8)

• Sex-adjusted prevalence of headache as an influenza symptom

  During the influenza seasons 2010-2022, an average of 1 year per season

• Sex-adjusted prevalence of headache as an influenza symptom - prospective

  During the influenza seasons 2022-2024, an average of 1 year per season

• Age-adjusted prevalence of headache as an influenza symptom

  During the influenza seasons 2010-2022, an average of 1 year per season

Study Arms (1)

Patients with headache during the course of influenza

Patients with influenza infection who experience new-onset headache during the course of the disease, or a two-fold worsening of a prior headache disorder, according to the International Classification of Headache Disorders

Other: Questionnaire administration

Interventions

Questionnaire administration OTHER

A trained physician will administer a structured questionnaire

Patients with headache during the course of influenza

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be patients with a confirmed influenza infection. Patients belonging to a general practitioner or sentinel pediatrician quota who are evaluated in primary care (PC) by an IRA. Sample collection is performed in some patients who consult within 5 days from the onset of symptoms, especially if there is a clinical picture of fever.

You may qualify if:

• Confirmed diagnosis of influenza virus infection, using molecular techniques (PCR) or antigen test.
• Age older than 18 years old.

You may not qualify if:

• 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.
• Decline to be interviewed.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead
• Red Centinela Sanitaria de Castilla y León (RCSCYL): collaborator
• Centro Nacional de Gripe de Valladolid (CNGV): collaborator
• Dirección General de Salud Pública de la Consejería de Sanidad de la Junta de Castilla y León: collaborator

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, 47010, Spain

RECRUITING

Related Publications (21)

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  PMID: 29248255 BACKGROUND

• Perez-Rubio A, Platero L, Eiros Bouza JM. Seasonal influenza in Spain: Clinical and economic burden and vaccination programmes. Med Clin (Barc). 2019 Jul 5;153(1):16-27. doi: 10.1016/j.medcli.2018.11.014. Epub 2019 Jan 6. English, Spanish.

  PMID: 30621906 BACKGROUND

• Redondo-Bravo L, Delgado-Sanz C, Oliva J, Vega T, Lozano J, Larrauri A; Spanish Influenza Sentinel Surveillance System. Transmissibility of influenza during the 21st-century epidemics, Spain, influenza seasons 2001/02 to 2017/18. Euro Surveill. 2020 May;25(21):1900364. doi: 10.2807/1560-7917.ES.2020.25.21.1900364.

  PMID: 32489178 BACKGROUND

• Ortiz de Lejarazu Leonardo R, Rojo Rello S, Sanz Munoz I. Diagnostic challenges in influenza. Enferm Infecc Microbiol Clin (Engl Ed). 2019 May;37 Suppl 1:47-55. doi: 10.1016/S0213-005X(19)30182-X. English, Spanish.

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• Brody H. Influenza. Nature. 2019 Sep;573(7774):S49. doi: 10.1038/d41586-019-02750-x. No abstract available.

  PMID: 31534258 BACKGROUND

• Eccles R. Mechanisms of symptoms of the common cold and influenza. Br J Hosp Med (Lond). 2007 Feb;68(2):71-5. doi: 10.12968/hmed.2007.68.2.22824. No abstract available.

  PMID: 17370703 BACKGROUND

• Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005 Nov;5(11):718-25. doi: 10.1016/S1473-3099(05)70270-X.

  PMID: 16253889 BACKGROUND

• Pedersen CJ, Quinn JV, Rogan DT, Yang S. Factors Associated With Influenza in an Emergency Department Setting. J Emerg Med. 2019 May;56(5):478-483. doi: 10.1016/j.jemermed.2018.12.012. Epub 2019 Feb 22.

  PMID: 30803847 BACKGROUND

• Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

  PMID: 29368949 BACKGROUND

• Trigo J, Garcia-Azorin D, Planchuelo-Gomez A, Martinez-Pias E, Talavera B, Hernandez-Perez I, Valle-Penacoba G, Simon-Campo P, de Lera M, Chavarria-Miranda A, Lopez-Sanz C, Gutierrez-Sanchez M, Martinez-Velasco E, Pedraza M, Sierra A, Gomez-Vicente B, Arenillas JF, Guerrero AL. Factors associated with the presence of headache in hospitalized COVID-19 patients and impact on prognosis: a retrospective cohort study. J Headache Pain. 2020 Jul 29;21(1):94. doi: 10.1186/s10194-020-01165-8.

  PMID: 32727345 BACKGROUND

• Garcia-Azorin D, Sierra A, Trigo J, Alberdi A, Blanco M, Calcerrada I, Cornejo A, Cubero M, Gil A, Garcia-Iglesias C, Lozano AG, Martinez Badillo C, Montilla C, Mora M, Nunez G, Paniagua M, Perez C, Rojas M, Ruiz M, Sierra L, Hurtado ML, Guerrero Peral AL. Frequency and phenotype of headache in covid-19: a study of 2194 patients. Sci Rep. 2021 Jul 19;11(1):14674. doi: 10.1038/s41598-021-94220-6.

  PMID: 34282206 BACKGROUND

• Caronna E, Ballve A, Llaurado A, Gallardo VJ, Ariton DM, Lallana S, Lopez Maza S, Olive Gadea M, Quibus L, Restrepo JL, Rodrigo-Gisbert M, Vilaseca A, Hernandez Gonzalez M, Martinez Gallo M, Alpuente A, Torres-Ferrus M, Pujol Borrell R, Alvarez-Sabin J, Pozo-Rosich P. Headache: A striking prodromal and persistent symptom, predictive of COVID-19 clinical evolution. Cephalalgia. 2020 Nov;40(13):1410-1421. doi: 10.1177/0333102420965157.

  PMID: 33146036 BACKGROUND

• Gonzalez-Martinez A, Fanjul V, Ramos C, Serrano Ballesteros J, Bustamante M, Villa Marti A, Alvarez C, Garcia Del Alamo Y, Vivancos J, Gago-Veiga AB. Headache during SARS-CoV-2 infection as an early symptom associated with a more benign course of disease: a case-control study. Eur J Neurol. 2021 Oct;28(10):3426-3436. doi: 10.1111/ene.14718. Epub 2021 Feb 2.

  PMID: 33417287 BACKGROUND

• Trigo J, Garcia-Azorin D, Sierra-Mencia A, Tamayo-Velasco A, Martinez-Paz P, Tamayo E, Guerrero AL, Gonzalo-Benito H. Cytokine and interleukin profile in patients with headache and COVID-19: A pilot, CASE-control, study on 104 patients. J Headache Pain. 2021 Jun 4;22(1):51. doi: 10.1186/s10194-021-01268-w.

  PMID: 34088273 BACKGROUND

• Lopez JT, Garcia-Azorin D, Planchuelo-Gomez A, Garcia-Iglesias C, Duenas-Gutierrez C, Guerrero AL. Phenotypic characterization of acute headache attributed to SARS-CoV-2: An ICHD-3 validation study on 106 hospitalized patients. Cephalalgia. 2020 Nov;40(13):1432-1442. doi: 10.1177/0333102420965146.

  PMID: 33146037 BACKGROUND

• Garcia-Azorin D, Trigo J, Talavera B, Martinez-Pias E, Sierra A, Porta-Etessam J, Arenillas JF, Guerrero AL. Frequency and Type of Red Flags in Patients With Covid-19 and Headache: A Series of 104 Hospitalized Patients. Headache. 2020 Sep;60(8):1664-1672. doi: 10.1111/head.13927. Epub 2020 Aug 18.

  PMID: 32790215 BACKGROUND

• Planchuelo-Gomez A, Trigo J, de Luis-Garcia R, Guerrero AL, Porta-Etessam J, Garcia-Azorin D. Deep Phenotyping of Headache in Hospitalized COVID-19 Patients via Principal Component Analysis. Front Neurol. 2020 Dec 17;11:583870. doi: 10.3389/fneur.2020.583870. eCollection 2020.

  PMID: 33391152 BACKGROUND

• Garcia-Azorin D, Layos-Romero A, Porta-Etessam J, Membrilla JA, Caronna E, Gonzalez-Martinez A, Mencia AS, Segura T, Gonzalez-Garcia N, Diaz-de-Teran J, Gallardo VJ, Gago-Veiga AB, Ballve A, Trigo Lopez J, Sastre-Real M, Llaurado A, Cornejo A, de Lorenzo I, Guerrero-Peral A, Pozo-Rosich P. Post-COVID-19 persistent headache: A multicentric 9-months follow-up study of 905 patients. Cephalalgia. 2022 Jul;42(8):804-809. doi: 10.1177/03331024211068074. Epub 2022 Feb 15.

  PMID: 35166156 BACKGROUND

• Garcia-Azorin D, Santana-Lopez L, Lozano-Alonso JE, Ordax-Diez A, Gonzalez-Osorio Y, Rojo-Rello S, Eiros JM, Sanchez-Martinez J, Recio-Garcia A, Sierra-Mencia A, Sanz-Munoz I, Guerrero-Peral AL. InfluenCEF study: Clinical phenotype and duration of headache attributed to influenza infection. Cephalalgia. 2023 Nov;43(11):3331024231212900. doi: 10.1177/03331024231212900.

  PMID: 37950674 DERIVED

Related Links

• Boletín informativo de la Red Centinela Sanitaria de Castilla y León, 2022
• World Health Organization Europe. WHO Regional Office for Europe guidance for sentinel influenza surveillance inhumans. May 2011.

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab with sterile swab samples are sent to local laboratories where molecular analysis is performed by PCR to detect influenza viruses and other respiratory pathogens.

MeSH Terms

Conditions

Headache Disorders; Headache; Migraine Disorders; Virus Diseases; Influenza, Human

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Study Officials

• David García Azorín, MD, PhD

  Sanidad de Castilla y León

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David García Azorín, MD, PhD

CONTACT

+34665872228; davilink@hotmail.com

Yesica González Osorio, MBA

CONTACT

634330426; ygoinvestigacion@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David García-Azorín, MD, PhD

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 30, 2023
• Study Start: December 20, 2022
• Primary Completion: April 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

ES (1)