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Acute Upper Respiratory Tract Infection - When is Bacteria Involved?

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ClinicalTrials.gov Identifier: NCT01580137
Recruitment Status : Unknown
Verified October 2013 by Oulu University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2012
Last Update Posted : October 30, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Upper Respiratory Tract Infection - When is Bacteria Involved?
Study Start Date : February 2012
Primary Completion Date : April 2012
Estimated Study Completion Date : April 2014
Groups and Cohorts

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)

Outcome Measures

Primary Outcome Measures :
  1. Bacterial maxillary sinusitis [ Time Frame: 2 months ]
    Bacterial maxillary sinusitis defined as positive culture results from the maxillary puncture (either side)

Secondary Outcome Measures :
  1. Bacterial sinusitis [ Time Frame: 2 months ]
    positive bacterial pcr results from either maxillary sinus

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580137

Finnish Defence Force, Centre for Military Medicine
Kajaani, Kainuu, Finland, FI 87500
Sponsors and Collaborators
Oulu University Hospital
Finnish Defense Forces
The Central Hospital of Kajaani
Huslab, Clinical Microbiology, Virology and Immunology
University of Oulu
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

Responsible Party: Oulu University Hospital
ClinicalTrials.gov Identifier: NCT01580137     History of Changes
Other Study ID Numbers: Diary number 235/2011
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Oulu University Hospital:
acute respiratory tract infection
common cold
acute bacterial rhinosinusitis

Additional relevant MeSH terms:
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases