Middle Meatal Bacteriology During Acute Respiratory Infection in Children

Sponsor

Oulu University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00545961

Collaborator

(none)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Infection Sinusitis	Drug: placebo Drug: amoxicillin clavulanate acid	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2007

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug	Drug: placebo mixture, 0.28125 ml/kg twice a day for 7 days Other Names: Ora-Plus (registered trademark) mixture
Active Comparator: 2 amoxicillin-clavulanate acid	Drug: amoxicillin clavulanate acid mixture 0.28125 ml / kg twice a day for 7 days Other Names: Clavurion mixture (Orion Oy)

Arm

Intervention/Treatment

Placebo Comparator: 1

placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug

Drug: placebo

mixture, 0.28125 ml/kg twice a day for 7 days

Other Names:

Ora-Plus (registered trademark) mixture

Active Comparator: 2

amoxicillin-clavulanate acid

Drug: amoxicillin clavulanate acid

mixture 0.28125 ml / kg twice a day for 7 days

Other Names:

Clavurion mixture (Orion Oy)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Keski-pohjanmaan keskussairaala	Kokkola	Finland
2	Oulu University Hospital	Oulu	Finland
3	Etelä-Pohjanmaan Keskussairaala	Seinäjoki	Finland

Sponsors and Collaborators

Oulu University Hospital

Investigators

Principal Investigator: 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: Anna Marttila, MD, Dept of Otolaryngology, University of Oulu, Finland
Study Director: Olli-Pekka Alho, professor, Dept of Otolaryngology, University of Oulu, Finland
Study Director: Aila Kristo, MD, Dept of Otolaryngology, University of Oulu, Finland
Principal Investigator: Ulla Lantto, MD, Dept of Otolaryngology, University of Oulu, Finland