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Acute Upper Respiratory Tract Infection - When is Bacteria Involved?

NCT ID: NCT01580137

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis

Keywords

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acute respiratory tract infection common cold acute bacterial rhinosinusitis adult conscript

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy conscripts

non allergic subjects who have not a history of recurrent rhinosinusitis

No interventions assigned to this group

subjects with recurrent rhinosinusitis

subjects who have experienced recurrent rhinosinusitis episodes (3 during the previous 3 years)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finnish Defense Forces

OTHER_GOV

Sponsor Role collaborator

The Central Hospital of Kajaani

UNKNOWN

Sponsor Role collaborator

Huslab, Clinical Microbiology, Virology and Immunology

UNKNOWN

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Petri Koivunen, Dosent

Role: PRINCIPAL_INVESTIGATOR

Dept of Otolaryngology, University of Oulu, Finland

Timo Koskenkorva, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otolaryngology, University of Oulu, Finland

Mervi Närkiö, MD

Role: PRINCIPAL_INVESTIGATOR

Finnish Defence Force

Locations

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Finnish Defence Force, Centre for Military Medicine

Kajaani, Kainuu, Finland

Site Status

Countries

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Finland

Other Identifiers

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Diary number 235/2011

Identifier Type: -

Identifier Source: org_study_id