Middle Meatal Bacteriology During Acute Respiratory Infection in Children

Study Overview
=================
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 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.

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

Conditions
-----------------
Acute Respiratory Infection, Sinusitis

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: amoxicillin clavulanate acid


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug | Drug: placebo<br>* mixture, 0.28125 ml/kg twice a day for 7 days<br>* Other names: Ora-Plus (registered trademark) mixture;|
| Active Comparator: 2<br>amoxicillin-clavulanate acid | Drug: amoxicillin clavulanate acid<br>* mixture 0.28125 ml / kg twice a day for 7 days<br>* Other names: Clavurion mixture (Orion Oy);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry. |  | within the first 3 weeks after enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 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) |  | 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 |  | within the first three weeks after enrolment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory infection, sinusitis, rhinosinusitis, children, middle meatal specimens, respiratory track bacteria, amoxicillin-clavulanate, pneumococci, haemophilus, moraxella