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Middle Meatal Bacteriology During Acute Respiratory Infection in Children

NCT ID: NCT00545961

Last Updated: 2007-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Infection Sinusitis

Keywords

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respiratory infection sinusitis rhinosinusitis children middle meatal specimens respiratory track bacteria amoxicillin-clavulanate pneumococci haemophilus moraxella

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

2

amoxicillin-clavulanate acid

Group Type ACTIVE_COMPARATOR

amoxicillin clavulanate acid

Intervention Type DRUG

mixture 0.28125 ml / kg twice a day for 7 days

Interventions

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placebo

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

Intervention Type DRUG

amoxicillin clavulanate acid

mixture 0.28125 ml / kg twice a day for 7 days

Intervention Type DRUG

Other Intervention Names

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Ora-Plus (registered trademark) mixture Clavurion mixture (Orion Oy)

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Jukka-Pekka Kuusiniemi, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otolaryngology, Seinäjoki Central Hospital, Finland

Eeva Löfgren, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otolaryngology, Kokkola Central Hospital, Finland

Anna Marttila, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otolaryngology, University of Oulu, Finland

Olli-Pekka Alho, professor

Role: STUDY_DIRECTOR

Dept of Otolaryngology, University of Oulu, Finland

Aila Kristo, MD

Role: STUDY_DIRECTOR

Dept of Otolaryngology, University of Oulu, Finland

Ulla Lantto, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otolaryngology, University of Oulu, Finland

Locations

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Keski-pohjanmaan keskussairaala

Kokkola, , Finland

Site Status

Oulu University Hospital

Oulu, , Finland

Site Status

Etelä-Pohjanmaan Keskussairaala

Seinäjoki, , Finland

Site Status

Countries

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Finland

Central Contacts

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Aila A Kristo, MD

Role: CONTACT

Phone: +35883153492

Email: [email protected]

Olli-Pekka Alho, MD

Role: CONTACT

Phone: +35883153473

Email: [email protected]

Other Identifiers

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Diary nr 41/2007

Identifier Type: -

Identifier Source: org_study_id