Clinical Trial: Middle Meatal Bacteriology During Acute Respiratory Infection in Children

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study

Brief Summary: The purpose of this study is to find out whether the children with respiratory infection and the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus benefit from antimicrobial treatment.

Detailed Summary:

Acute sinusitis is one of the most common disease in children requiring antimicrobial treatment. The diagnosis and treatment outcomes of acute sinusitis are contradictory, and better diagnostic criteria are needed. In adults with acute maxillary sinusitis, bacterial culture results obtained from the nasal middle meatus are comparable to those obtained from sinus puncture and aspiration. In children, the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus during respiratory infection predicts longer duration of signs and symptoms of common cold.

In this randomized placebo-controlled study, the effect of the antimicrobial treatment (amoxicillin-clavulanate) is examined in children with pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus during respiratory infection. The duration of the symptoms and speed of recovery is recognized by daily symptom-diary, the results are compared between the treatment groups.


Sponsor: Oulu University Hospital

Current Primary Outcome: Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry. [ Time Frame: within the first 3 weeks after enrolment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • duration (days)and severity (grade mild, severe) of different symptoms (clear nasal discharge, coloured nasal discharge, nasal obstruction, cough, throat pain, ear ache, fever, headache, diarrhea) [ Time Frame: within the first three weeks after enrolment ]
  • number of days the child is using the following symptomatic drugs (pain killers, nasal vasoconstrictors, nasal corticosteroids, asthma drugs, antihistamines) [ Time Frame: within the first three weeks after the enrolment ]
  • number of days the child is not at school and that the parents are not at work [ Time Frame: within the first three weeks after enrolment ]


Original Secondary Outcome: Same as current

Information By: Oulu University Hospital

Dates:
Date Received: October 17, 2007
Date Started: November 2007
Date Completion: December 2009
Last Updated: October 18, 2007
Last Verified: October 2007