Acute Upper Respiratory Tract Infection - When is Bacteria Involved?

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Finnish Defense Forces
The Central Hospital of Kajaani
Huslab, Clinical Microbiology, Virology and Immunology
University of Oulu
Information provided by (Responsible Party):
Oulu University Hospital
ClinicalTrials.gov Identifier:
NCT01580137
First received: April 17, 2012
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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
Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Upper Respiratory Tract Infection - When is Bacteria Involved?

Resource links provided by NLM:


Further study details as provided by Oulu University Hospital:

Primary Outcome Measures:
  • Bacterial maxillary sinusitis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Bacterial maxillary sinusitis defined as positive culture results from the maxillary puncture (either side)


Secondary Outcome Measures:
  • Bacterial sinusitis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    positive bacterial pcr results from either maxillary sinus


Estimated Enrollment: 48
Study Start Date: February 2012
Estimated Study Completion Date: April 2014
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/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)

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

Ages Eligible for Study:   18 Years to 28 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580137

Locations
Finland
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
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
  More Information

No publications provided

Responsible Party: Oulu University Hospital
ClinicalTrials.gov Identifier: NCT01580137     History of Changes
Other Study ID Numbers: Diary number 235/2011
Study First Received: April 17, 2012
Last Updated: October 29, 2013
Health Authority: Finland: Finnish Medicines Agency

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

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

ClinicalTrials.gov processed this record on October 01, 2014