Investigation of Clinical Spectrum, Bacterial Pathogens and Immune Response in Acute Pharyngotonsillitis
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|ClinicalTrials.gov Identifier: NCT00926198|
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : September 8, 2010
Acute pharyngotonsillitis is one of the most common infections encountered by pediatricians. Most children with acute pharyngotonsillitis have symptoms that can be attributed to viral infection. However 30-40% of cases is of bacterial etiology.
The purpose of this study is to examine frequency, age distribution, clinical picture and pathogen distribution in acute pharyngotonsillitis in children in a large urban setting.
|Condition or disease|
According to the US Vital Health Statistics report, acute pharyngotonsillitis is responsible for more than 6 million office visits each year by children younger than 15 years of age. Approximately 30% of cases is of bacterial etiology and group A beta-hemolytic streptococci(GABHS) are responsible for most bacterial cases, although other pathogens, such as Neisseria gonorrhoeae, Arcanobacterium haemolyticum, Mycoplasma pneumoniae, and Chlamydia pneumoniae, may be the causative agents in sporadic cases. An accurate diagnosis of GABHS infection is important because it is the only common form of acute pharyngotonsillitis for which antibiotic therapy is definitely indicated. Effective antibacterial treatment can shorten the clinical course of GABHS pharyngotonsillitis, reduce the rate of transmission, and prevent suppurative and nonsuppurative complications, such as peritonsillar abscess and acute rheumatic fever.
This study enrolls patients who will present with acute fever and clinical signs of pharyngotonsillitis at three primary pediatric ambulances. A rapid A beta-hemolytic streptococcus (GABHS)-detection test will be performed in these patients. In one office, additional throat cultures are obtained of all patients, and blood is taken in a subgroup of 60 GABHS-positive and 60 GABHS-negative cases. In GABHS-positive patients, a second blood sample will be obtained at day 7th and day 28th, and stored until specific antibody response to GABHS will be measured.
|Study Type :||Observational|
|Estimated Enrollment :||4500 participants|
|Official Title:||Frequency, Pathogen Spectrum and Specific Immune Response in Acute Pharyngotonsillitis in Children and Adolescents|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926198
|Babenhausen, Hessen, Germany, 64832|
|Dietzenbach, Hessen, Germany, 63128|
|Offenbach-Rumpenheim, Hessen, Germany, 63075|
|Principal Investigator:||Stefan Zielen, Prof.||Medaimun GmbH and Johann Wolfgang Goethe University|