NCT00545961

Middle Meatal Bacteriology During Acute Respiratory Infection in Children

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Acute Respiratory Infection
• Sinusitis

Interventions

Type	Name	Description
DRUG	placebo	mixture, 0.28125 ml/kg twice a day for 7 days
DRUG	amoxicillin clavulanate acid	mixture 0.28125 ml / kg twice a day for 7 days

Timeline

• Start date: 2007-11-01
• Completion: 2009-12-01
• First posted: 2007-10-18
• Last updated: 2007-10-19

Locations

3 sites across 1 country: Finland