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Susceptibility to respiratory tract infections

Organizational Data

DRKS-ID:
DRKS00003381
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2011-12-08
Last update in DRKS:
2011-12-08
Registration type:
Retrospective

Acronym/abbreviation of the study

AWIS

URL of the study

No Entry

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.

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.

Health condition or problem studied

Free text:
ATEMWEGSINFEKTANFLLIGKEIT
ICD10:
J00 - Acute nasopharyngitis [common cold]
ICD10:
J01 - Acute sinusitis
ICD10:
J02 - Acute pharyngitis
ICD10:
J03 - Acute tonsillitis
ICD10:
J04 - Acute laryngitis and tracheitis
ICD10:
J05 - Acute obstructive laryngitis [croup] and epiglottitis
ICD10:
J06 - Acute upper respiratory infections of multiple and unspecified sites
ICD10:
J12 - Viral pneumonia, not elsewhere classified
ICD10:
J13 - Pneumonia due to Streptococcus pneumoniae
ICD10:
J14 - Pneumonia due to Haemophilus influenzae
ICD10:
J15 - Bacterial pneumonia, not elsewhere classified
ICD10:
J16 - Pneumonia due to other infectious organisms, not elsewhere classified
ICD10:
J17 - Pneumonia in diseases classified elsewhere
ICD10:
J18 - Pneumonia, organism unspecified
ICD10:
J20 - Acute bronchitis
ICD10:
J21 - Acute bronchiolitis
ICD10:
J22 - Unspecified acute lower respiratory infection
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Group of individuals with the 7.5% highest respiratory tract infection scores - these will be asked to provide a saliva sample.
Arm 2:
Group of individuals with the 40% lowest respiratory tract infection scores - these will be asked to provide a saliva sample.

Endpoints

Primary outcome:
To determine the proportion and characteristics of individuals in Germany with frequent and/or severe RTI of unknown cause.
Secondary outcome:
To identify genetic susceptibility biomarkers for this phenotype for subsequent prospective validation in independent study populations.

Study Design

Purpose:
Basic research/physiological study
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
Epidemiological study

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Centrum für Chronische Immundefizienz Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2011-12-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
1500
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
20 Years
Maximum Age:
70 Years
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).

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

Addresses

Primary Sponsor

Universitätsklinikum Freiburg
Hugstetter Strasse 49
79095 Freiburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Centrum für Chronische Immundefizienz Freiburg
PD Dr. Alexandra Nieters
Engesser Strasse 4
79108 Freiburg
Germany
Telephone:
+49-761-270 78150
Fax:
No Entry
Contact per E-Mail
URL:
http://www.cci.uniklinik-freiburg.de

Contact for Public Queries

Centrum für Chronische Immundefizienz, Freiburg
PD Dr. Alexandra Nieters
Engesser Strasse 4
79198 Freiburg
Germany
Telephone:
+49 761 270 77481
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de/cci/

Principal Investigator

Centrum für Chronische Immundefizienz Freiburg
PD Dr. Alexandra Nieters
Engesser Strasse 4
79108 Freiburg
Germany
Telephone:
+49-761-270 78150
Fax:
No Entry
Contact per E-Mail
URL:
http://www.cci.uniklinik-freiburg.de

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

BMBF Bundesministerium für Bildung und Forschung
Heinemannstraße 2
53175 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2011-07-07
Ethics committee number:
258/11
Vote of the Ethics Committee:
Approved
Date of the vote:
2011-07-11

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry