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

Completed

• Conditions: Tonsillitis

• Registration Number: NCT00926198
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-22
• Study First Posted: 2009-06-23
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-07
• Last Update Posted: 2010-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The responsible pathogens (Frequency of GABHS) of acute pharyngotonsillitis and its clinical and serological response in children in a large urban setting.	1 year

Secondary Outcome Measures

Name	Time	Method
In a subset of patients the immune response to GABHS will be measured at beginning and after 7 and 28 days.	one month

Trial Locations

Locations (2)

Paediatric office; 🇩🇪 Offenbach-Rumpenheim, Hessen, Germany

Paeditric office; 🇩🇪 Babenhausen, Hessen, Germany