Clinical trial NCT00545961: Middle Meatal Bacteriology During Acute Respiratory Infection in Children
Official title: Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Respiratory Infection
Sinusitis
Keywords: respiratory infection
sinusitis
rhinosinusitis
children
middle meatal specimens
respiratory track bacteria
amoxicillin-clavulanate
pneumococci
haemophilus
moraxella
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2007-10-18
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.
timeFrame: within the first 3 weeks after enrolment
Secondary outcomes:
measure: 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)
timeFrame: within the first three weeks after enrolment
measure: number of days the child is using the following symptomatic drugs (pain killers, nasal vasoconstrictors, nasal corticosteroids, asthma drugs, antihistamines)
timeFrame: within the first three weeks after the enrolment
measure: number of days the child is not at school and that the parents are not at work
timeFrame: within the first three weeks after enrolment
Other outcomes:
Locations:
city: Kokkola
country: Finland
facility: Keski-pohjanmaan keskussairaala
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Etelä-Pohjanmaan Keskussairaala
Study officials:
affiliation: Dept of Otolaryngology, Seinäjoki Central Hospital, Finland
name: Jukka-Pekka Kuusiniemi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Otolaryngology, Kokkola Central Hospital, Finland
name: Eeva Löfgren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Anna Marttila, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Olli-Pekka Alho, professor
role: STUDY_DIRECTOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Aila Kristo, MD
role: STUDY_DIRECTOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Ulla Lantto, MD
role: PRINCIPAL_INVESTIGATOR
References: