Investigation of Clinical Spectrum, Bacterial Pathogens and Immune Response in Acute Pharyngotonsillitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926198
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : September 8, 2010
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:

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

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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
throat culture, blood sample

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 3 months to 18 years who will present clinical signs of tonsillopharyngitis.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00926198

Paeditric office
Babenhausen, Hessen, Germany, 64832
Paediatric office
Dietzenbach, Hessen, Germany, 63128
Paediatric office
Offenbach-Rumpenheim, Hessen, Germany, 63075
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Principal Investigator: Stefan Zielen, Prof. Medaimun GmbH and Johann Wolfgang Goethe University

Responsible Party: Prof. Stefan Zielen, Medaimun GmbH and Johann Wolfgang Goethe University Hospitals Identifier: NCT00926198     History of Changes
Other Study ID Numbers: KGU- 31/09
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: September 8, 2010
Last Verified: September 2010

Keywords provided by Johann Wolfgang Goethe University Hospital:
Upper airway infections

Additional relevant MeSH terms:
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases