Acute Upper Respiratory Tract Infection and Acute Bacterial RhinosinusitisNCT01580137
Acute Upper Respiratory Tract Infection - When is Bacteria Involved?
An observational study of Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis, run by Oulu University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to find out if we can predict the progress of acute upper respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric oxide measurement. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis
- How many people
- 48 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2012to Apr 2014
- 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 28 years
- All sexes
- No healthy volunteers
- Adult
Study population: Finnish conscripts from the prigade of Kainuu who suffer from acute common cold with nasal symptoms. Consecutive sample. Subjects with known allergies, nasal polyps and prior sinus surgery are excluded.
Who may be able to join
- Conscript with acute upper respiratory tract infection symptoms (nasal obstruction/decongestion, post nasal drip or nasal secretion) lasted for 2-4 days
Who cannot join
- Allergy, asthma, nasal polyposis, sinus surgery, autoimmune illness
Trial locations and contacts
1 site in 1 country.
Finland1 site
Finnish Defence Force, Centre for Military Medicine
Kajaani, Kainuu, FI 87500
About this study
The purpose of this study is to find out if we can predict the progress of acute upper respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric oxide measurement.
Read the detailed description
We will recruit conscripts with upper respiratory tract infection (common cold) during a two month period. We will recruit non-allergic conscripts. These conscripts should either have not had history of recurrent ABR or they should have experienced recurrent acute (ABR) bacterial rhinosinusitis at least 3 times during the last two years (diagnosed by a doctor and at least one time with x-ray or sinus puncture). The recruits will keep a record of their symptoms. They will be examined by a doctor soon after the symptoms have started (2-4 days) and when the symptoms have lasted about 7-10 days. Clinical examination, nasal endoscopy and ultrasonographic examination of the maxillary sinuses are made, middle meatal specimen for bacteria and bacteria-pcr are taken, virus-pcr samples are taken from the nostril and nasopharynx, Nitric oxide-measurements from both nasal cavities are recorded. Cone beam CT of the maxillary and ethmoidal sinuses is made during the first examination, 2-4 days later and during the last examination. If the last CT-scan shows any other radiological signs than mild mucosal oedema in either maxillary sinus, maxillar sinus puncture is made and secretion is aspirated for culture and PCR. Biopsy from the mucosa of nasal cavity (middle meatal area) is taken to examine the cilia and possible bacteria biofilm.
- Keywords
- acute respiratory tract infection, common cold, acute bacterial rhinosinusitis, adult, conscript
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy conscripts | non allergic subjects who have not a history of recurrent rhinosinusitis | |
| subjects with recurrent rhinosinusitis | subjects who have experienced recurrent rhinosinusitis episodes (3 during the previous 3 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial maxillary sinusitis
Bacterial maxillary sinusitis defined as positive culture results from the maxillary puncture (either side)
Measured: 2 months
Secondary outcomes (1)
Bacterial sinusitis
positive bacterial pcr results from either maxillary sinus
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Respiratory Tract Infection and Acute Bacterial RhinosinusitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Defense Forces, The Central Hospital of Kajaani, Huslab, Clinical Microbiology, Virology and Immunology, University of Oulu
- Responsible party
- Sponsor
- Investigators
- Petri Koivunen, Dosent, Principal investigator, Dept of Otolaryngology, University of Oulu, FinlandTimo Koskenkorva, MD, Principal investigator, Dept of Otolaryngology, University of Oulu, FinlandMervi Närkiö, MD, Principal investigator, Finnish Defence Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580137
- Sponsor's protocol ID
- Diary number 235/2011
- Status last verified
- Oct 2013
- First submitted
- 17 Apr 2012
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Upper Respiratory Tract Infection - When is Bacteria Involved?
- ClinicalTrials.gov ID
- NCT01580137
- Acronym / sponsor ID
- Diary number 235/2011
- Keywords
- acute respiratory tract infection, common cold, acute bacterial rhinosinusitis, adult, conscript
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Finnish Defense Forces, The Central Hospital of Kajaani, Huslab, Clinical Microbiology, Virology and Immunology, University of Oulu
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2014 (estimated)
- First posted
- 18 Apr 2012 (estimated)
- 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 purpose of this study is to find out if we can predict the progress of acute upper respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric oxide measurement.
Detailed description
We will recruit conscripts with upper respiratory tract infection (common cold) during a two month period. We will recruit non-allergic conscripts. These conscripts should either have not had history of recurrent ABR or they should have experienced recurrent acute (ABR) bacterial rhinosinusitis at least 3 times during the last two years (diagnosed by a doctor and at least one time with x-ray or sinus puncture). The recruits will keep a record of their symptoms. They will be examined by a doctor soon after the symptoms have started (2-4 days) and when the symptoms have lasted about 7-10 days. Clinical examination, nasal endoscopy and ultrasonographic examination of the maxillary sinuses are made, middle meatal specimen for bacteria and bacteria-pcr are taken, virus-pcr samples are taken from the nostril and nasopharynx, Nitric oxide-measurements from both nasal cavities are recorded. Cone beam CT of the maxillary and ethmoidal sinuses is made during the first examination, 2-4 days later and during the last examination. If the last CT-scan shows any other radiological signs than mild mucosal oedema in either maxillary sinus, maxillar sinus puncture is made and secretion is aspirated for culture and PCR. Biopsy from the mucosa of nasal cavity (middle meatal area) is taken to examine the cilia and possible bacteria biofilm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy conscripts | – | –non allergic subjects who have not a history of recurrent rhinosinusitis |
| subjects with recurrent rhinosinusitis | – | –subjects who have experienced recurrent rhinosinusitis episodes (3 during the previous 3 years) |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Finnish conscripts from the prigade of Kainuu who suffer from acute common cold with nasal symptoms. Consecutive sample. Subjects with known allergies, nasal polyps and prior sinus surgery are excluded.
Key inclusion criteria (1 listed)
- Conscript with acute upper respiratory tract infection symptoms (nasal obstruction/decongestion, post nasal drip or nasal secretion) lasted for 2-4 days
Key exclusion criteria (1 listed)
- Allergy, asthma, nasal polyposis, sinus surgery, autoimmune illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial maxillary sinusitis
Time frame: 2 months
Bacterial maxillary sinusitis defined as positive culture results from the maxillary puncture (either side)
1 secondary outcome
Bacterial sinusitis
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
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.
Petri Koivunen, Dosent principal investigator
Dept of Otolaryngology, University of Oulu, Finland
Timo Koskenkorva, MD principal investigator
Dept of Otolaryngology, University of Oulu, Finland
Mervi Närkiö, MD principal investigator
Finnish Defence Force
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 Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis, run by Oulu University Hospital at 1 site in Finland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2013. 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 Finland. 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?
Results are not available in the source record.
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?
Bacterial maxillary sinusitis (time frame: 2 months). 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 30 Oct 2013.