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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00926198 |
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Date of registration:
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22/06/2009 |
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Primary sponsor: |
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Public title:
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Investigation of Clinical Spectrum, Bacterial Pathogens and Immune Response in Acute Pharyngotonsillitis
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Scientific title:
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Frequency, Pathogen Spectrum and Specific Immune Response in Acute Pharyngotonsillitis in Children and Adolescents |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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4500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00926198 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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Countries of recruitment
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Germany
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Contacts
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Name:
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Stefan Zielen, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medaimun GmbH and Johann Wolfgang Goethe University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age 3 months to 18 years
- clinical signs of tonsillopharyngitis
- informed consent
Exclusion Criteria:
- age more than 18 years
- diagnosed chronic disease or infection (e.x. HIV, tuberculosis, malignancy)
- current participation in another research projects that may interfere with this study
- Incapability to perform all study procedure
Age minimum:
3 Months
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tonsillitis
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Primary Outcome(s)
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The responsible pathogens (Frequency of GABHS) of acute pharyngotonsillitis and its clinical and serological response in children in a large urban setting.
[Time Frame: 1 year]
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Secondary Outcome(s)
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In a subset of patients the immune response to GABHS will be measured at beginning and after 7 and 28 days.
[Time Frame: one month]
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Secondary ID(s)
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KGU- 31/09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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