Trial document




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  DRKS00003381

Trial Description

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Title

Susceptibility to respiratory tract infections

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Trial Acronym

AWIS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Data regarding the relevance of lifestyle factors, genetic and immunological factors in the susceptibility to respiratory tract infections is sparse. In an epidemiological study funded by the German ministry for education and research with the acronym AWIS, we will first assess the frequency of respiratory tract infections in 30.000 randomly chosen residents of Freiburg and county Breisgau-Hochschwarzwald. Subsequently, consenting individuals with frequent/severe respiratory tract infections (n=750) and those with few infections (n=750) will be invited to participate in sub-studies with the aim to identify underlying factors explaining inter-individual differences in susceptibility and severity of respiratory tract infections.

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Brief Summary in Scientific Language

Data regarding the relevance of lifestyle factors, genetic and immunological factors in the susceptibility to respiratory tract infections is sparse. In a BMBF-funded population-based cross-sectional study with acronym AWIS, we will first assess the frequency of respiratory tract infections in 30.000 randomly chosen residents of Freiburg and county Breisgau-Hochschwarzwald. Subsequently, consenting individuals with frequent/severe respiratory tract infections (n=750) and those with few infections (n=750) will be invited to participate in sub-studies with the aim to identify underlying factors explaining inter-individual differences in susceptibility and severity of respiratory tract infections.

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Organizational Data

  •   DRKS00003381
  •   2011/12/08
  •   [---]*
  •   yes
  •   Approved
  •   258/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   ATEMWEGSINFEKTANFLLIGKEIT
  •   J00 -  Acute nasopharyngitis [common cold]
  •   J01 -  Acute sinusitis
  •   J02 -  Acute pharyngitis
  •   J03 -  Acute tonsillitis
  •   J04 -  Acute laryngitis and tracheitis
  •   J05 -  Acute obstructive laryngitis [croup] and epiglottitis
  •   J06 -  Acute upper respiratory infections of multiple and unspecified sites
  •   J12 -  Viral pneumonia, not elsewhere classified
  •   J13 -  Pneumonia due to Streptococcus pneumoniae
  •   J14 -  Pneumonia due to Haemophilus influenzae
  •   J15 -  Bacterial pneumonia, not elsewhere classified
  •   J16 -  Pneumonia due to other infectious organisms, not elsewhere classified
  •   J17 -  Pneumonia in diseases classified elsewhere
  •   J18 -  Pneumonia, organism unspecified
  •   J20 -  Acute bronchitis
  •   J21 -  Acute bronchiolitis
  •   J22 -  Unspecified acute lower respiratory infection
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Interventions/Observational Groups

  •   Group of individuals with the 7.5% highest respiratory tract infection scores - these will be asked to provide a saliva sample.
  •   Group of individuals with the 40% lowest respiratory tract infection scores - these will be asked to provide a saliva sample.
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Characteristics

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

To determine the proportion and characteristics of individuals in Germany with frequent and/or severe RTI of unknown cause.

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Secondary Outcome

To identify genetic susceptibility biomarkers for this phenotype for subsequent prospective validation in independent study populations.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/12/01
  •   1500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   70   Years
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Additional Inclusion Criteria

Screening study (step 1)
20-70 years of age
- comprehension of German language
- resident of Freiburg and Breisgau/Hochschwarzwald
- consent for participation in questionnaire study.

Supplementary study (step 2):
same as above
- lack of indicated co-morbidities
- consent for participation in supplementary study including consent to 1) provide a saliva samples as source of genomic DNA, 2) to allow study nurse to contact participant and primary care physician to validate phenotype
- highest 7.5% of RTI score (group 1)
- lowest 40% RTI score (group 2).

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Exclusion Criteria

Screening study:
- Residence outside study region
- non-comprehension of German language
- lack of consent

Supplementary study:
same as above
- prevalence of indicated co-morbidities
- lack of consent for supplementary study
- RTI score outside range of interest

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Centrum für Chronische Immundefizienz Freiburg
    • Ms.  PD Dr.  Alexandra  Nieters 
    • Engesser Strasse 4
    • 79108  Freiburg
    • Germany
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    • Centrum für Chronische Immundefizienz, Freiburg
    • Ms.  PD Dr.  Alexandra  Nieters 
    • Engesser Strasse 4
    • 79198  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • BMBF Bundesministerium für Bildung und Forschung
    • Heinemannstraße 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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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.