gms | German Medical Science

Background and state of the art: The haphazardly hospital use of antibiotics is one of the main causes for the increase of multi-resistant bacteria in clinical practice. Lately, various Antibiotic Stewardship Programs (ASP) were implemented to reduce unnecessary antibiotic use and optimize the utilization of this important therapeutic resource. In Germany, most ASP were introduced in university clinics and developed for adults. There is a lack of pediatric-specific ASP in non-university hospitals.

Research question and aim: The overall aim of this study is to counteract the increasing antibiotic resistance by implementing an ASP in non-university pediatric hospitals that will be supported by university clinics. Primary outcome is the reduction of antibiotic use. The primary research question is: Does an ASP reduce the antibiotic use in pediatric non-university hospitals? Secondary outcomes include the adherence to current guidelines, length of stay and in-hospital mortality. Process evaluation will be performed (compliance and acceptance by physicians, health economic evaluation).

Methods: Study design: This study is a cluster randomized study with a stepped wedge design. An ASP will be implemented in 35 non-university pediatric hospitals. University clinics with expertise in treatment of infectious diseases in children support the non-university clinics in optimizing their antibiotic treatment via counselling service and training. Telemedicine will be used with a Web App as the central element of the counselling service and training. Other elements of the ASP include analysis of antibiotic use and antibiotic resistance statistics. The ASP in the clinics will be implemented stepwise. In the beginning of the implementation phase of 22 month, no clinic is in the intervention group and in the end every clinic is in the intervention group. Each month, more clinics change from control to intervention group. The time point when a clinic starts the intervention phase will be randomly assigned.

Data collection: Data of the monthly antibiotic use will be collected by the pharmacies in the clinics. For the secondary outcomes and process evaluation, data will be retrieved from the clinics.

Statistical analysis: The reduction in antibiotic use will be estimated with a Poisson mixed effects model. This model includes the clinics as random effect. Seasonality, monthly time trends and the intervention will be included as fixed effects.

Results: To date, there are no results. This study will start in October 2020 and will have a duration of 36 month.

Discussion: Previous studies clearly elucidated that implementing an ASP in pediatric inpatient facilities reduces antibiotic use without compromising patient’s safety. We expect to show a decrease in antibiotic use and no negative effects on length of stay and in-hospital mortality.

Practical implications: Telemedicine with the use of a Web App could facilitate the implementation of an ASP in non-university clinics with little expertise in infectious disease therapy. The engagement in the clinics in the development of the ASP could increase acceptance, use of the ASP as well as adherence to current guidelines. This could optimize antibiotic use and care in non-university pediatric hospitals.