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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug
• Active Comparator: 2
  • amoxicillin-clavulanate acid

Primary Measures

• Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.
  • Time Frame: within the first 3 weeks after enrolment
    

Secondary Measures

• 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
    

Inclusion Criteria:

• acute respiratory infection with nasal symptoms (nasal obstruction or discharge)
• seeking medical help from health centre for the respiratory symptoms
• pathogenic bacteria (S pneumoniae, H influenzae or M catarrhalis) identified from right or left nasal middle meatus in the endoscopically taken swab culture sampling taken by a study investigator (all microbiological analyses are done by the National
• Public Health Institute´s microbiological laboratory in Oulu)

Exclusion Criteria:

• otitis, tonsillitis or other disease requiring antimicrobial treatment
• respiratory infection within 4 weeks of screening
• antimicrobial treatment within 4 weeks of screening
• allergy to penicillin or amoxicillin

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 13 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oulu University Hospital

Overall Clinical Trial Officials and Contacts

Jukka-Pekka Kuusiniemi, MD Principal Investigator Dept of Otolaryngology, Seinäjoki Central Hospital, Finland  

Overall Contact: Aila A Kristo, MD +35883153492 aila.kristo@ppshp.fi

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00545961

Study ID Number: Diary nr 41/2007

ClinicalTrials.gov Identifier: NCT00545961

Health Authority: Finland: National Agency for Medicines