NCT00926198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 8, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

June 22, 2009

Last Update Submit

September 7, 2010

Conditions

Keywords

Upper airway infectionspharyngotonsillitisGABHS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • In a subset of patients the immune response to GABHS will be measured at beginning and after 7 and 28 days.

    one month

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 3 months to 18 years who will present clinical signs of tonsillopharyngitis.

You may qualify if:

  • age 3 months to 18 years
  • clinical signs of tonsillopharyngitis
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Paeditric office

Babenhausen, Hesse, 64832, Germany

Location

Paediatric office

Dietzenbach, Hesse, 63128, Germany

Location

Paediatric office

Offenbach-Rumpenheim, Hesse, 63075, Germany

Location

Related Publications (3)

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

    PMID: 14632102BACKGROUND
  • 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.

    PMID: 17137534BACKGROUND
  • 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.

    PMID: 10378093BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

throat culture, blood sample

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Stefan Zielen, Prof.

    Medaimun GmbH and Johann Wolfgang Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 8, 2010

Record last verified: 2010-09

Locations