Acute Upper Respiratory Tract Infection - When is Bacteria Involved?
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.
Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis
|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
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||April 2014|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580137
|Finnish Defence Force, Centre for Military Medicine|
|Kajaani, Kainuu, Finland, FI 87500|
|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|