Clinical trial NCT01580137: Acute Upper Respiratory Tract Infection - When is Bacteria Involved?
Official title: Acute Upper Respiratory Tract Infection - When is Bacteria Involved?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis
Keywords: acute respiratory tract infection
common cold
acute bacterial rhinosinusitis
adult
conscript
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: Finnish Defense Forces
name: The Central Hospital of Kajaani
name: Huslab, Clinical Microbiology, Virology and Immunology
name: University of Oulu
First posted: 2012-04-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Bacterial maxillary sinusitis
timeFrame: 2 months
Secondary outcomes:
measure: Bacterial sinusitis
timeFrame: 2 months
Other outcomes:
Locations:
city: Kajaani
country: Finland
facility: Finnish Defence Force, Centre for Military Medicine
state: Kainuu
Study officials:
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Petri Koivunen, Dosent
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Timo Koskenkorva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Finnish Defence Force
name: Mervi Närkiö, MD
role: PRINCIPAL_INVESTIGATOR
References: