Middle Meatal Bacteriology During Acute Respiratory Infection in Children

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00545961
• Other study ID #: Diary nr 41/2007
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 17, 2007
• Last updated: October 18, 2007
• Start date: November 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2007
• Source: Oulu University Hospital
• Contact: Aila A Kristo, MD
• Phone: +35883153492
• Email: aila.kristo[@]ppshp.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 13 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Sinusitis

Intervention

Drug:
• placebo
mixture, 0.28125 ml/kg twice a day for 7 days
• amoxicillin clavulanate acid
mixture 0.28125 ml / kg twice a day for 7 days

Locations

Country	Name	City	State
Finland	Keski-pohjanmaan keskussairaala	Kokkola
Finland	Oulu University Hospital	Oulu
Finland	Etelä-Pohjanmaan Keskussairaala	Seinäjoki

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.		within the first 3 weeks after enrolment
Secondary	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
Secondary	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
Secondary	number of days the child is not at school and that the parents are not at work		within the first three weeks after enrolment