MedDataX Logo

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

NCT ID: NCT00926198

Last Updated: 2010-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tonsillitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Medaimun GmbH and Johann Wolfgang Goethe University Hospitals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan Zielen, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medaimun GmbH and Johann Wolfgang Goethe University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Paeditric office

Babenhausen, Hesse, Germany

Site Status

Paediatric office

Dietzenbach, Hesse, Germany

Site Status

Paediatric office

Offenbach-Rumpenheim, Hesse, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 14632102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17137534 (View on PubMed)

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. doi: 10.1177/000992289903800606.

Reference Type BACKGROUND
PMID: 10378093 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KGU- 31/09

Identifier Type: -

Identifier Source: org_study_id