COVID19-ITS-KISS

COVID19-ITS-KISS - is a surveillance system for nosocomial superinfections and multidrug-resistant pathogens in COVID-19 patients in intensive care units.

1. Why are we conducting the COVID19-ITS study?

2. How do we proceed?

3. Data protection

Note for interested readers:

The study will start on 1 July 2021 and the recruitment phase will continue until the end of 2021.

Entry into the COVID19-ITS-KISS study is possible for intensive care units with around 100 COVID-19 patients until the end of the recruitment phase!

If you have any questions or require additional information, please contact the research team Dr Friederike Maechler, Prof Christine Geffers, Mrs Solvy Wolke or Mrs Elke Lemke.


Tel.: 030-450570233 oder 030-450577606

Fax: 030-450577920

Email: friederike.maechler@charite.de

 

Dear COVID19-ITS-KISS participants,

You can access the study materials (documents for training courses, brief descriptions of the project and FAQs ...) after logging in at the top right of this page.

1. Why are we conducting the COVID19-ITS-KISS study?

From reports from ITS-KISS participants and from our own observations, we know that the risk of bacterial co-infections (superinfections), fungal infections and multi-resistant pathogens (MRP) appears to be increased in COVID-19 patients compared to other ITS patients. However, there is no reliable data regarding this. So far, such infectious complications in COVID-19 ITS patients could not be used in a suitable form to draw conclusions about the efficiency of infection prevention measures. This is because they predominantly do not appear as new infections, but as pathogen switches in infections brought along. Some ITS-KISS participants have already approached us with the request to be able to record these cases in ITS-KISS as well.

We have therefore developed a surveillance component (COVID19-ITS-KISS) that can also be used to record such co-infections and MRE in COVID-19 patients receiving intensive care. The data is collected via the ‘webKess’ surveillance platform, which is standard practice in KISS. The risk of co-infection and MRE in COVID-19 patients can therefore be documented and compared in a standardised and stratified manner. The data is then available for your internal quality management and can be used to gain insights into the efficiency of infection prevention measures.

The development and implementation of this new surveillance component specifically for COVID-19 ITS patients is funded by the Federal Ministry of Education and Research (BMBF).

2. How do we proceed?

In this section we summarise the most important features of the COVID19-ITS-KISS method:

  • Surveillance component within the ITS-KISS should ideally run concurrent to the ITS-KISS infection surveillance programme
  • Patients included: all COVID-19 patients at the participating ITS
  • Patient-related surveillance method with documentation of data for each COVID-19 ITS patient (also for patients without a surveillance indicative event)
  • Events included in surveillance:
  1. Pathogen change during the time in the intensive care unit (ITS) for respiratory tract infections brought along
  2. New secondary sepsis during the ITS stay with respiratory tract infections brought along
  3. New nosocomial respiratory tract infections during the ITS stay
  4. New primary sepsis during the ITS stay
  5. New MRP findings during the ITS stay

Thanks to the BMBF funding, the study participants receive an expense allowance of 20 euros for each COVID-19 patient included.Data can be entered both retrospectively for the current pandemic and prospectively for the upcoming months.  Please note, however, that a maximum of 150 COVID-19 ITS patients per participating hospital can be paid (depending on the actual number of participants). A positive ethics vote by the ethics committee and a data protection vote were of course received in advance.

3. Data protection

The measures implemented within the study (introduction of surveillance with feedback) take place at intensive care unit level and aim to obtain data regarding the frequency of infection events and MRP in COVID-19 patients. The data should be used by the intensive care units for internal self-assessment of hygiene management. However, the collecting of data from a large number of facilities at national level will also allow us to obtain comparable data (reference data) and gives us the opportunity to analyse the development of the frequency of infection over time (prevalence).

All data is submitted to the trial centre, pseudonymised from the participants side, and evaluated in aggregated form. This means that the study team cannot draw any conclusions about individual patients and there are no risks with regard to data protection. In addition to the authorised users from the ward itself, only the study team has access to the results. The participation can be revoked at any time and will make any further use of the data inadmissible. A consultation for data protection has already been provided by the Charité Berlin.