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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug |
|
| 2 | Active Comparator | amoxicillin-clavulanate acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | mixture, 0.28125 ml/kg twice a day for 7 days |
|
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aila A Kristo, MD | Contact | +35883153492 | aila.kristo@ppshp.fi | |
| Olli-Pekka Alho, MD | Contact | +35883153473 | olli-pekka.alho@oulu.fi |
| Name | Affiliation | Role |
|---|---|---|
| Jukka-Pekka Kuusiniemi, MD | Dept of Otolaryngology, Seinäjoki Central Hospital, Finland | Principal Investigator |
| Eeva Löfgren, MD | Dept of Otolaryngology, Kokkola Central Hospital, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keski-pohjanmaan keskussairaala | Kokkola | Finland |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D012141 | Respiratory Tract Infections |
| D000096825 | Rhinosinusitis |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| amoxicillin clavulanate acid | Drug | mixture 0.28125 ml / kg twice a day for 7 days |
|
|
| 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 |
| Anna Marttila, MD | Dept of Otolaryngology, University of Oulu, Finland | Principal Investigator |
| Olli-Pekka Alho, professor | Dept of Otolaryngology, University of Oulu, Finland | Study Director |
| Aila Kristo, MD | Dept of Otolaryngology, University of Oulu, Finland | Study Director |
| Ulla Lantto, MD | Dept of Otolaryngology, University of Oulu, Finland | Principal Investigator |
| Oulu University Hospital | Oulu | Finland |
|
| Etelä-Pohjanmaan Keskussairaala | Seinäjoki | Finland |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D012220 | Rhinitis |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |