Acute Upper Respiratory Tract Infection - When is Bacteria Involved?

Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis Clinical Trial

Official title:

Acute Upper Respiratory Tract Infection - When is Bacteria Involved?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01580137
• Other study ID #: Diary number 235/2011
• Status: Active, not recruiting
• Phase: N/A
• First received: April 17, 2012
• Last updated: October 29, 2013
• Start date: February 2012
• Est. completion date: April 2014

Study information

• Verified date: October 2013
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: April 2014
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 28 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis
• Communicable Diseases
• Infection
• Respiratory Tract Infections

Locations

Country	Name	City	State
Finland	Finnish Defence Force, Centre for Military Medicine	Kajaani	Kainuu

Sponsors (5)

Lead Sponsor	Collaborator
Oulu University Hospital	Finnish Defense Forces, Huslab, Clinical Microbiology, Virology and Immunology, The Central Hospital of Kajaani, University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial maxillary sinusitis	Bacterial maxillary sinusitis defined as positive culture results from the maxillary puncture (either side)	2 months	No
Secondary	Bacterial sinusitis	positive bacterial pcr results from either maxillary sinus	2 months	No