TonsillitisNCT00926198
Investigation of Clinical Spectrum, Bacterial Pathogens and Immune Response in Acute Pharyngotonsillitis
An observational study of Tonsillitis, run by Johann Wolfgang Goethe University Hospital at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Tonsillitis
- How many people
- 4,500 participants
- Where
- 3 sitesGermany
- Study dates
- May 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 3 months to 18 years who will present clinical signs of tonsillopharyngitis.
Who may be able to join
- age 3 months to 18 years
- clinical signs of tonsillopharyngitis
- informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Paeditric office
Babenhausen, Hesse, 64832
Paediatric office
Dietzenbach, Hesse, 63128
Paediatric office
Offenbach-Rumpenheim, Hesse, 63075
About this study
Official title: Frequency, Pathogen Spectrum and Specific Immune Response in Acute Pharyngotonsillitis in Children and Adolescents
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.
Read the 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.
- Conditions
- Tonsillitis
- Keywords
- Upper airway infections, pharyngotonsillitis, GABHS
- Medical subject headings
- Tonsillitis
What is being measured
The primary outcome is the main question the study is designed to answer.
The responsible pathogens (Frequency of GABHS) of acute pharyngotonsillitis and its clinical and serological response in children in a large urban setting.
Measured: 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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Zielen, Prof., Principal investigator, Medaimun GmbH and Johann Wolfgang Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926198
- Sponsor's protocol ID
- KGU- 31/09
- Status last verified
- Sep 2010
- First submitted
- 22 Jun 2009
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Shulman ST. Acute streptococcal pharyngitis in pediatric medicine: current issues in diagnosis and management. Paediatr Drugs. 2003;5 Suppl 1:13-23.
PubMed 14632102Brook I, Dohar JE. Management of group A beta-hemolytic streptococcal pharyngotonsillitis in children. J Fam Pract. 2006 Dec;55(12):S1-11; quiz S12.
PubMed 17137534Nussinovitch 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.
PubMed 10378093
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency, Pathogen Spectrum and Specific Immune Response in Acute Pharyngotonsillitis in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00926198
- Acronym / sponsor ID
- KGU- 31/09
- Conditions
- Tonsillitis
- Keywords
- Upper airway infections, pharyngotonsillitis, GABHS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 3 months to 18 years who will present clinical signs of tonsillopharyngitis.
Key inclusion criteria (3 listed)
- age 3 months to 18 years
- clinical signs of tonsillopharyngitis
- informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Background: PubMed 14632102Shulman ST. Acute streptococcal pharyngitis in pediatric medicine: current issues in diagnosis and management. Paediatr Drugs. 2003;5 Suppl 1:13-23.
- Background: PubMed 17137534Brook I, Dohar JE. Management of group A beta-hemolytic streptococcal pharyngotonsillitis in children. J Fam Pract. 2006 Dec;55(12):S1-11; quiz S12.
- Background: PubMed 10378093Nussinovitch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Zielen, Prof. principal investigator
Medaimun GmbH and Johann Wolfgang Goethe University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillitis, run by Johann Wolfgang Goethe University Hospital at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00926198, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2010.