NCT06127186

Brief Summary

The goal of this longitudinal study is to assess headache and facial pain features in patients with upper respiratory tract infections (URTI). The main question it aims to answer are:

  • answer standardized questions,
  • undergo physical examination,
  • have a swab test performend for antigens of common viruses causing URTI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

November 4, 2023

Last Update Submit

April 6, 2024

Conditions

Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with one of the specified pain phenotypes

    Percentage of patients with one of the specified pain phenotypes (migraine-like/tension-type-like/trigeminal cephalalgia-like)

    A single assessment during primary care physician office 1 day visit.

Study Arms (1)

Study group

Patients reporting for primary care assessment because of URTI.

Diagnostic Test: Swab test for viral antigens

Interventions

Swab test for viral antigensDIAGNOSTIC_TEST

No intervention except for a routine examination and viral testing is planned.

Also known as: Standarised questionnaire, Physical examination
Study group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with upper respiratory tract infection.

You may qualify if:

  • URTI confirmed by primary care physician
  • Informed consent to participate in the study

You may not qualify if:

  • chronic or recurrent upper respiratory tract disorders
  • neoplasms
  • signs or symptoms of a serious neurologic or psychiatric disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcin Straburzyński

Dźwierzuty, Warmian-Masurian Voivodeship, 12-120, Poland

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2023

First Posted

November 13, 2023

Study Start

November 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Anonymized data will be made available in a public repository after study completion.

Shared Documents
STUDY PROTOCOL

Locations

PL(1)