This trial is active, not recruiting.

Condition acute upper respiratory tract infection and acute bacterial rhinosinusitis
Sponsor Oulu University Hospital
Collaborator Finnish Defense Forces
Start date February 2012
End date April 2012
Trial size 48 participants
Trial identifier NCT01580137, Diary number 235/2011


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
non allergic subjects who have not a history of recurrent rhinosinusitis
subjects who have experienced recurrent rhinosinusitis episodes (3 during the previous 3 years)

Primary Outcomes

Bacterial maxillary sinusitis
time frame: 2 months

Secondary Outcomes

Bacterial sinusitis
time frame: 2 months

Eligibility Criteria

Male or female participants from 18 years up to 28 years old.

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

Additional Information

Official title Acute Upper Respiratory Tract Infection - When is Bacteria Involved?
Principal investigator Petri Koivunen, Dosent
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Oulu University Hospital.