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.

Study Overview

• Status: Unknown
• Conditions: Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis

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 Type: Observational
• Enrollment (Anticipated): 48

Contacts and Locations

Study Locations

• Finland
  • Kainuu
    • Kajaani, Kainuu, Finland, FI 87500
      • Finnish Defence Force, Centre for Military Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial maxillary sinusitis	Bacterial maxillary sinusitis defined as positive culture results from the maxillary puncture (either side)	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial sinusitis	positive bacterial pcr results from either maxillary sinus	2 months

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: University of Oulu; Finnish Defense Forces; The Central Hospital of Kajaani; Huslab, Clinical Microbiology, Virology and Immunology
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ANTICIPATED): April 1, 2014

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: April 17, 2012
• First Posted (ESTIMATE): April 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: adult; common cold; acute respiratory tract infection; acute bacterial rhinosinusitis; conscript
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: Diary number 235/2011