Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007801

Trial Description

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Title

Acute versus chronic inflammation: analysis of the T-cell function in the tonsilla palatina as surrogate marker of the immune status with patients with peritonsillar abscess versus patients with chronic tonsillitis

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Trial Acronym

HTTS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The main purpose of the study is to investigate the immune status of patients with severe local infection or chronic inflammation in tissue from tonsils, as easily available secondary lymphoid organ.
The background of the study is to investigate the T cell function of these patients in order to distinguish and identify of immunological processes caused by acute systemic inflammatory reactions versus chronic local inflammatory reactions.
There are examined tonsils of patients with chronic tonsillitis as well as of patients with peritonsillar abscess. As controls serve tonsils taken from patients with rhonchopathy.
Potential study participants are patients in whom the tonsils are routinely removed due to chronic or acute inflammation or due to rhonchopathy.
Patient recruiting has already begun within the primary study "Systemic versus local inflammation: Analysis of tonsillar T-cell function as a surrogate marker of the immune status in sepsis versus chronic tonsillitis" (DRKS 00005313); however, due to recruiting problems of sepsis patients the study was early terminated and the study design was changed.

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Brief Summary in Scientific Language

The main purpose of the study is to investigate the functional characteristics of T cells in tonsils of patients with 1) severe local inflammatory reaction (perionsillar abscess) to sepsis, 2) chronic tonsillits and 3) hypertrophy of tonsils (rhonchopathy) to identify differences in the immune reaction caused by antigen stimulation in lymphatic tissue between 1) acute and partly systemic versus 2) chronic and local inflammation and 3) control T-lymphocytes. We expact that the analysis of the T-cell function of these 3 groups let us find out important parameters and characteristics for the differentiation and identification of immunological processes caused by acute systemic inflammation reactions versus chronic local inflammation reactions. Furthermore, we will try to investigate the possibility of using tonsils (as the only secondary lymphatic organ) for the analysis and diagnosis of the immunological status of patients concerned.

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Organizational Data

  •   DRKS00007801
  •   2015/02/27
  •   [---]*
  •   yes
  •   Approved
  •   3972-01/14, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J36 -  Peritonsillar abscess
  •   J35.0 -  Chronic tonsillitis
  •   J35.1 -  Hypertrophy of tonsils
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Interventions/Observational Groups

  •   Patient with peritonsillar abscess and emergent tonsillectomy; taking of tissue samples of palatine tonsils
  •   Patients with chronic tonsillitis and
    scheduled resection of palatine tonsils; taking of tissue samples of palatine tonsils
  •   Patients with rhonchopathy due to tonsil hypertrophy and scheduled resection of palatine tonsils; taking of tissue samples of palatine tonsils
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Difference in the T cell response of patients with peritonsillar abscess, chronic tonsillitis and tonsil hyperplasia regarding activation, proliferation and apoptosis and thereby investigate the existence of T cell specific parameters to systemic and local inflammation

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Secondary Outcome

Investigation of the use of the tonsils, as an easily available secondary lymphoid organ, for the determination of the immune status of patients with severe local inflammatory reaction to sepsis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/01/24
  •   21
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

All patient groups:
1. male or female patients, age at least 18 years
2. written informed consent

Only patient group A:
patients with peritonsillar abscess and emergent tonsillectomy

Only patient group B:
patients with chronic tonsillitis (with 3 or more episodes of recidival acute tonsillitides per year) and scheduled for routine tonsillectomy

Only patient group C:
patients without acute or chronic tonsillitis, but scheduled for routine tonsilectomy due to rhonchopathy or obstructive sleep apnea syndrome

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Exclusion Criteria

1. therapy with steroids or other immunosuppressive therapy
2. severe chronic diseases in medical history
3. Therapy with coagulation inhibitors or abnormally low coagulation status

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Addresses

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    • Integriertes Forschungs- und Behandlungszentrum Sepsis und SepsisfolgenKlinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
    • Mr.  Prof. Dr.  Orlando  Guntinas-Lichius 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde Universitätsklinikum Jena
    • Lessingstraße 2
    • 07743  Jena
    • Germany
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    •   [---]*
    •   [---]*
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    • Integriertes Forschungs- und Behandlungszentrum Sepsis und SepsisfolgenKlinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
    • Mr.  Prof. Dr.   Orlando  Guntinas-Lichius 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Integriertes Forschungs- und BehandlungszentrumSepsis und SepsisfolgenKlinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
    • Mr.  Prof. Dr.  Orlando  Guntinas-Lichius 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Center for Sepsis Control and Care (CSCC)
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/09/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.