Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00019059

Trial Description

start of 1:1-Block title

Title

Reduction of antibiotic resistance by guideline-based treatment of patients with uncomplicated urinary tract infection in outpatient care, subproject a)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

REDARES

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://innovationsfonds.g-ba.de/projekte/versorgungsforschung/redares-reduktion-von-antibiotikaresistenzen-durch-leitliniengerechte-behandlung-von-patienten-mit-unkompliziertem-harnwegsinfekt-in-der-ambulanten-versorgung.248

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In subproject a) of the REDARES study, the resistance situation in uncomplicated urinary tract infections in Germany will be investigated. A urinary tract infection is considered uncomplicated if there are no diseases or anatomical deviations in the area of ​​the urinary tract that could complicate the treatment. For this purpose, a total of 3,500 women from all over Germany will be included with clinically diagnosed uncomplicated urinary tract infection.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In a cross-sectional study, the resistance of the causative agent of uncomplicated UTIs in the outpatient sector from all over Germany is collected in order to provide up-to-date regional resistance data of the most common pathogens for uncomplicated UTIs. By comparing the current resistance situation with the 2015/2016 data collected in the context of the SARHA study on the resistance situation of community-acquired uncomplicated UTIs and the comparison with the routine data of the antibiotic resistance surveillance (ARS), which primarily reflects the resistance situation of community-acquired complicated UTIs, a statistical model will be developed to predict the resistance levels of uncomplicated UTIs from the ARS routine data.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Forwarding of patient-related data:

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

Once the resistance data collected have been evaluated, they are transmitted in anonymous and aggregated form via Cryptshare to the study director (Prof. Dr. Ildikó Gágyor, University Hospital Würzburg).

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00019059
  •   2019/11/28
  •   [---]*
  •   yes
  •   Approved
  •   EA2/127/19, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   N39.0 -  Urinary tract infection, site not specified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The aim of the study is to assess the current resistance situation of uncomplicated urinary tract infections acquired on an outpatient basis throughout Germany. Patients with clinically diagnosed uncomplicated urinary tract infections will give a urine sample which will be examined microbiologically. In addition, a questionnaire is completed.
    By comparing the current resistance situation with the data collected in the SARHA study in 2015/2016 on the resistance situation of outpatient acquired uncomplicated HWI and comparing it with the routine data in ARS, which primarily reflect the resistance situation of outpatient acquired complicated HWI, a statistical model is to be developed which will enable the prognosis of the resistance components of uncomplicated HWI from the routine ARS data.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   [---]*
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Data on the local resistance situation of HWI pathogens are collected consecutively in all patients with uncomplicated urinary tract infections. A mapping of the resistance situation of the pathogens of the uncomplicated HWI in outpatient care is achieved without distortion by selection, e.g. by complicated cases. The current and regional resistance components of uncomplicated HWI are to be calculated and made available to outpatient physicians using the ARS routine data.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

/

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/10/01
  •   3500
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Outpatient clinically diagnosed uncomplicated urinary tract infection

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Men,
Women <18 years,
urinary catheter,
immunosuppression,
functional /anatomical changes (e.g., after surgery),
urological renal diseases, kidney stones

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Allgemeinmedizin Universitätsklinikum Würzburg
    • Ms.  Prof. Dr. med.  Ildikó   Gágyor 
    • Josef-Schneider-Str. 2/D7
    • 97080  Würzburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Robert Koch-Institut
    • Mr.  Dr. med.  Tim  Eckmanns 
    • Seestraße 10
    • 13353  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Robert Koch-Institut
    • Ms.  Anja  Klingeberg 
    • Seestraße 10
    • 13353  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Gutenbergstraße 13
    • 10587  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications


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