Sinusitis Clinical Trial
Official title:
Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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