Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00545961
Study type Interventional
Source Oulu University Hospital
Contact Aila A Kristo, MD
Phone +35883153492
Email aila.kristo@ppshp.fi
Status Not yet recruiting
Phase Phase 4
Start date November 2007
Completion date December 2009

See also
  Status Clinical Trial Phase
Recruiting NCT03584178 - The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis N/A
Completed NCT06016335 - MRI-based Synthetic CT Images of the Head and Neck N/A
Active, not recruiting NCT02278484 - Sinus Balloon Dilation in Pediatric Patients N/A
Withdrawn NCT02071667 - Association of Periostin Levels and Chronic Sinusitis N/A
Completed NCT01420471 - Medicated Punctured-Glove-Finger Spacer Study Phase 4
Completed NCT01118312 - Study of Asthma and Nasal Steroids Phase 4
Completed NCT00645762 - Balloon REmodeling Antrostomy THErapy Study Phase 2
Completed NCT01685229 - Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
Active, not recruiting NCT03943121 - The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps N/A
Withdrawn NCT02900794 - Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery N/A
Terminated NCT02630472 - Topical Irrigation Therapy for CRS Phase 1/Phase 2
Completed NCT01442740 - 15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients N/A
Completed NCT01001039 - Validation of the Facial and Cephalic Pain Inventory N/A
Completed NCT01033799 - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers N/A
Completed NCT00335309 - Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis N/A
Completed NCT00242437 - Hemostatic Matrix in Endoscopic Sinus Surgery Phase 4
Completed NCT00236522 - A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults. Phase 3
Completed NCT01717274 - Hot Saline Irrigation Study N/A
Completed NCT01166945 - Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children N/A
Completed NCT00747747 - Sinuclean's Treatment Of Sinusitis' Symptoms Phase 4