Middle Meatal Bacteriology During Acute Respiratory Infection in Children

Condition(s) targeted: Acute Respiratory Infection; Sinusitis

Intervention: placebo (Drug); amoxicillin clavulanate acid (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Oulu University Hospital

Official(s) and/or principal investigator(s):
Jukka-Pekka Kuusiniemi, MD, Principal Investigator, Affiliation: Dept of Otolaryngology, Seinäjoki Central Hospital, Finland
Eeva Löfgren, MD, Principal Investigator, Affiliation: Dept of Otolaryngology, Kokkola Central Hospital, Finland
Anna Marttila, MD, Principal Investigator, Affiliation: Dept of Otolaryngology, University of Oulu, Finland
Olli-Pekka Alho, professor, Study Director, Affiliation: Dept of Otolaryngology, University of Oulu, Finland
Aila Kristo, MD, Study Director, Affiliation: Dept of Otolaryngology, University of Oulu, Finland
Ulla Lantto, MD, Principal Investigator, Affiliation: Dept of Otolaryngology, University of Oulu, Finland

Overall contact:
Aila A Kristo, MD, Phone: +35883153492, Email: aila.kristo@ppshp.fi

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.

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

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

Primary outcome: Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.

Secondary outcome:

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)

number of days the child is using the following symptomatic drugs (pain killers, nasal vasoconstrictors, nasal corticosteroids, asthma drugs, antihistamines)

number of days the child is not at school and that the parents are not at work

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.

Minimum age: 6 Years. Maximum age: 13 Years. Gender(s): Both.

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

Aila A Kristo, MD, Phone: +35883153492, Email: aila.kristo@ppshp.fi

Keski-pohjanmaan keskussairaala, Kokkola, Finland; Not yet recruiting
Eeva Löfgren, MD, Sub-Investigator

Oulu University Hospital, Oulu, Finland; Not yet recruiting
Aila Kristo, MD, Principal Investigator
Anna Marttila, MD, Sub-Investigator
Ulla Lantto, MD, Sub-Investigator

Etelä-Pohjanmaan Keskussairaala, Seinäjoki, Finland; Not yet recruiting
Jukka-Pekka Kuusiniemi, MD, Sub-Investigator

Starting date: November 2007
Last updated: October 18, 2007