Upper Respiratory Tract InfectionsNCT06127186
Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections
An observational study of Upper Respiratory Tract Infections, run by Marcin Straburzynski at 1 site in Poland.
Trial 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: 1. What is the phenotype of headache / facial pain in URTIs 2. Does the above mentioned phenotype is associated with: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- Swab test for viral antigens
- How many people
- 223 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with upper respiratory tract infection.
Who may be able to join
- URTI confirmed by primary care physician
- Informed consent to participate in the study
Who cannot join
- chronic or recurrent upper respiratory tract disorders
- neoplasms
- signs or symptoms of a serious neurologic or psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Marcin Straburzyński
Dźwierzuty, Warmian-Masurian Voivodeship, 12-120
About this study
Official title: Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections - a Cross-sectional Study in Primary Care Setting
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:
- What is the phenotype of headache / facial pain in URTIs
- Does the above mentioned phenotype is associated with:
- aetiologic factor (virus),
- type of URTI
- headache/facial pain experienced by patients in the past.
Participants will:
- answer standardized questions,
- undergo physical examination,
- have a swab test performend for antigens of common viruses causing URTI.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- Swab test for viral antigens
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swab test for viral antigensDiagnostic test
Also called Standarised questionnaire, Physical examination
No intervention except for a routine examination and viral testing is planned.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients reporting for primary care assessment because of URTI. Receives: Diagnostic Test: Swab test for viral antigens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: A single assessment during primary care physician office 1 day visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Nov 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcin Straburzynski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcin Straburzynski, Swiat Zdrowia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127186
- Sponsor's protocol ID
- URTI HA FP
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be made available in a public repository after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections - a Cross-sectional Study in Primary Care Setting
- ClinicalTrials.gov ID
- NCT06127186
- Acronym / sponsor ID
- URTI HA FP
- Conditions
- Upper Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Marcin StraburzynskiUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the phenotype of headache / facial pain in URTIs
- Does the above mentioned phenotype is associated with:
- aetiologic factor (virus),
- type of URTI
- headache/facial pain experienced by patients in the past.
Participants will:
- answer standardized questions,
- undergo physical examination,
- have a swab test performend for antigens of common viruses causing URTI.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Swab test for viral antigensPatients reporting for primary care assessment because of URTI. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with upper respiratory tract infection.
Key inclusion criteria (2 listed)
- URTI confirmed by primary care physician
- Informed consent to participate in the study
Key exclusion criteria (3 listed)
- chronic or recurrent upper respiratory tract disorders
- neoplasms
- signs or symptoms of a serious neurologic or psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swab test for viral antigensAlso: Standarised questionnaire, Physical examinationNo intervention except for a routine examination and viral testing is planned. | Diagnostic test | Study group |
Primary outcome
Percentage of patients with one of the specified pain phenotypes
Time frame: A single assessment during primary care physician office 1 day visit.
Percentage of patients with one of the specified pain phenotypes (migraine-like/tension-type-like/trigeminal cephalalgia-like)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Yes. Anonymized data will be made available in a public repository after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Respiratory Tract Infections, run by Marcin Straburzynski at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with one of the specified pain phenotypes (time frame: A single assessment during primary care physician office 1 day visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.