Trial document




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  DRKS00005367

Trial Description

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Title

Prospective study on the relevance of the detection of respiratory viruses in pharyngeal aspirates in healthy individuals

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Pharyngeal Aspirates (washes) from healthy donors will be tested for viral pathogens which commonly cause the common cold. The tests applied use nucleic acid detection of viral species. This is a novel method and leads to more positive results than conventional methods. In the clinical context it is not clear, what the relevance of positive results obtained by this method is and whether the detected pathogens always cause disease. For this reason we would like to investigate healthy donors systematically and correlate the findings from pharyngeal aspirates with symptoms, stress level, smoking and other clinical factors. The study aims at clarifying whether the detected pathogens cause the disease or merely represent a clinically meaningless colonisation.

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Brief Summary in Scientific Language

Respiratory pathogens are increasingly recognised as potential causes for severe infections in the immunocompromised host. Most commonly, pathogens are detected from pharyngeal aspirates (PA) using PCR. Although there is an increasing number of reports of severe respiratory infections caused by pathogens which were diagnosed by PCR in symptomatic, often immunosuppressed, patients, there is very little knowledge as to the rate of positive results in PA from healthy, asymptomatic or symptomatic donors. Our group currently conducts a prospective study to investigate the prevalence of positive results in healthy donors during the winter months. After recruitment and written informed consent, healthy participants undergo a PA and fill in a questionnaire regarding current symptoms of upper respiratory tract infections. Three weeks later, the same procedure is routinely repeated with an additional follow-up questionnaire after another week. In case of symptoms of upper respiratory tract infections after the second visit, the participant is asked to provide a third NPA and another questionnaire. We plan to recruit 111 participants per season (duration of study: seasons autumn 2013- spring 2014 and autumn 2014- spring 2014) to be able to detect a prevalence of 10% with a 95%-Confidence Interval (CI) of 10% in the whole group. To date, this will be the first prospective study investigating healthy, asymptomatic and symptomatic donors during the European winter months. Subsequent studies will investigate immunocompromised hosts in addition to healthy donors. Our data will provide us with important baseline information for the interpretation of positive results in symptomatic, immunocompromised patients.

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Organizational Data

  •   DRKS00005367
  •   2013/10/17
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  •   yes
  •   Approved
  •   3891-09/13, 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

  •   J00-J06 -  Acute upper respiratory infections
  •   Healthy Volunteer
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Interventions/Observational Groups

  •   The participants are asked to provide pharyngeal aspirates twice within 3 weeks and are questioned regarding symptoms of a common cold. In case of acute respiratory infections within the following 2 months, participants are asked to provide another sample and fill in another questionnaire. The samples are analysed using multiplex PCR in the laboratory of the research group.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

prevalence of positive results for viral pathogens in pharyngeal aspirates from healthy donors determined by multiplex PCR at timepoint 0, 3 weeks later and at the onset of an acute respiratory infection

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Secondary Outcome

correlation of positive results for viral pathogens determined by PCR with symptoms, stress level and smoking at timepoint 0, 3 weeks later and at the onset of an acute respiratory infection

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/11/15
  •   222
  •   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

- >17 years of age
- written informed consent

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Exclusion Criteria

- no informed consent
- pulmonary disease of any kind with or without medication
-Disease that leads to immunosuppression at study entry or within the past 5 years including diabetes mellitus
-immunosuppressive or immunemodulating medication at study entry or within the past 5 years

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Addresses

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • Universitätsklinikum Jena
    • Ms.  Prof.  Marie  von Lilienfeld-Toal 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Universitätsklinikum Jena
    • Ms.  Ramona  Kraft 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Interdisziplinäres Zentrum für Klinische Forschung (IZKF) Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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