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

Tonsillitis Clinical Trial

Official title:

Frequency, Pathogen Spectrum and Specific Immune Response in Acute Pharyngotonsillitis in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926198
• Other study ID #: KGU- 31/09
• Status: Completed
• Phase: N/A
• First received: June 22, 2009
• Last updated: September 7, 2010
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2010
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4500
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Tonsillitis

Locations

Country	Name	City	State
Germany	Paeditric office	Babenhausen	Hessen
Germany	Paediatric office	Dietzenbach	Hessen
Germany	Paediatric office	Offenbach-Rumpenheim	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Brook I, Dohar JE. Management of group A beta-hemolytic streptococcal pharyngotonsillitis in children. J Fam Pract. 2006 Dec;55(12):S1-11; quiz S12. Review. — View Citation

Nussinovitch M, Finkelstein Y, Amir J, Varsano I. Group A beta-hemolytic streptococcal pharyngitis in preschool children aged 3 months to 5 years. Clin Pediatr (Phila). 1999 Jun;38(6):357-60. — View Citation

Shulman ST. Acute streptococcal pharyngitis in pediatric medicine: current issues in diagnosis and management. Paediatr Drugs. 2003;5 Suppl 1:13-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The responsible pathogens (Frequency of GABHS) of acute pharyngotonsillitis and its clinical and serological response in children in a large urban setting.		1 year	No
Secondary	In a subset of patients the immune response to GABHS will be measured at beginning and after 7 and 28 days.		one month	No