Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study
Sponsor study identifier
interventional
120
1 country
3
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2007
Actual (reported)October 18, 2007
Actual (reported)November 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.
within the first 3 weeks after enrolment
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
placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug
amoxicillin-clavulanate acid
mixture, 0.28125 ml/kg twice a day for 7 days
mixture 0.28125 ml / kg twice a day for 7 days
Keski-pohjanmaan keskussairaala
Kokkola, Finland
Oulu University Hospital
Oulu, Finland
Etelä-Pohjanmaan Keskussairaala
Seinäjoki, Finland
Jukka-Pekka Kuusiniemi, MD
Dept of Otolaryngology, Seinäjoki Central Hospital, Finland
Eeva Löfgren, MD
Dept of Otolaryngology, Kokkola Central Hospital, Finland
Anna Marttila, MD
Dept of Otolaryngology, University of Oulu, Finland
Olli-Pekka Alho, professor
Dept of Otolaryngology, University of Oulu, Finland
First Submitted
October 17, 2007
First Posted
October 18, 2007
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
December 2009
Estimated (date passed)Xolair in Patients With Chronic Sinusitis
number of days the child is not at school and that the parents are not at work
within the first three weeks after enrolment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Aila Kristo, MD
Dept of Otolaryngology, University of Oulu, Finland
Ulla Lantto, MD
Dept of Otolaryngology, University of Oulu, Finland
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 19, 2007
Record last verified: 2007-10
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Source: ClinicalTrials.gov.
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