Middle Meatal Bacteriology During Acute Respiratory Infection in Children

Phase 4

• Conditions: Acute Respiratory Infection; Sinusitis
• Interventions: Drug: placebo; Drug: amoxicillin clavulanate acid

• Registration Number: NCT00545961
• Lead Sponsor: Oulu University Hospital

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.

Study Timeline

• Status Verified: 2007-10
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-18
• Last Update Submitted: 2007-10-18
• Last Update Posted: 2007-10-19
• Study Start: 2007-11
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	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	amoxicillin clavulanate acid	amoxicillin-clavulanate acid

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Oulu University Hospital; 🇫🇮 Oulu, Finland

Keski-pohjanmaan keskussairaala; 🇫🇮 Kokkola, Finland

Etelä-Pohjanmaan Keskussairaala; 🇫🇮 Seinäjoki, Finland