Acute Upper Respiratory Tract Infection - When is Bacteria Involved?
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Purpose
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.
| Condition |
|---|
|
Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Acute Upper Respiratory Tract Infection - When is Bacteria Involved? |
- Bacterial maxillary sinusitis [ Time Frame: 2 months ] [ Designated as safety issue: No ]Bacterial maxillary sinusitis defined as positive culture results from the maxillary puncture (either side)
- Bacterial sinusitis [ Time Frame: 2 months ] [ Designated as safety issue: No ]positive bacterial pcr results from either maxillary sinus
| Estimated Enrollment: | 48 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
healthy conscripts
non allergic subjects who have not a history of recurrent rhinosinusitis
|
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subjects with recurrent rhinosinusitis
subjects who have experienced recurrent rhinosinusitis episodes (3 during the previous 3 years)
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 28 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Conscript with acute upper respiratory tract infection symptoms (nasal obstruction/decongestion, post nasal drip or nasal secretion) lasted for 2-4 days
Exclusion Criteria:
- Allergy, asthma, nasal polyposis, sinus surgery, autoimmune illness
Contacts and Locations| Contact: Timo J Autio, MD | +35883152011 | timoauti@mail.student.oulu.fi |
| Contact: Olli-Pekka Alho, professor | +35883152011 | olli-pekka.alho@oulu.fi |
| Finland | |
| Finnish Defence Force, Centre for Military Medicine | Recruiting |
| Kajaani, Kainuu, Finland, FI 87500 | |
| Contact: Mervi Närkiö, MD mervi.narkio@mil.fi | |
| Principal Investigator: | Petri Koivunen, Dosent | Dept of Otolaryngology, University of Oulu, Finland |
| Principal Investigator: | Timo Koskenkorva, MD | Dept of Otolaryngology, University of Oulu, Finland |
| Principal Investigator: | Mervi Närkiö, MD | Finnish Defence Force |
More Information
No publications provided
| Responsible Party: | Oulu University Hospital |
| ClinicalTrials.gov Identifier: | NCT01580137 History of Changes |
| Other Study ID Numbers: | Diary number 235/2011 |
| Study First Received: | April 17, 2012 |
| Last Updated: | April 17, 2012 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by Oulu University Hospital:
|
acute respiratory tract infection common cold acute bacterial rhinosinusitis adult conscript |
Additional relevant MeSH terms:
|
Respiratory Tract Infections Common Cold Sinusitis Infection Respiratory Tract Diseases Picornaviridae Infections |
RNA Virus Infections Virus Diseases Paranasal Sinus Diseases Nose Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013