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PurposeThe primary aim of our study was to assess pregnancy outcome after first-trimester exposure to fosfomycin.MethodsWe performed an observational cohort study analysing prospectively ascertained pregnancies including 152 women exposed to fosfomycin in the first trimester of pregnancy in comparison with a randomly selected cohort comprising 456 pregnancies not exposed to fosfomycin. All pregnancies were identified through risk consultations using structured questionnaires between January 2000 and December 2016 by the German Embryotox pharmacovigilance institute in Berlin. Primary objectives were the risks of major birth defects and spontaneous abortion.ResultsOnly 1 out of 146 exposed infants was affected by a major birth defect (0.7%, 95% CI 0.04–4.33%) in comparison to 15/399 in the non-exposed cohort (3.8%, 95% CI 2.2–6.26%). Spontaneous abortions were observed in 5/152 cases in the fosfomycin cohort vs. 53/456 cases in the comparison cohort (cumulative incidence 6.2% vs. 23.1%; HR adjusted 0.35, 95% CI 0.14–0.90).ConclusionThis is the first study specifically examining the teratogenic risk of fosfomycin. The study results do not indicate an increased risk of adverse pregnancy outcome after fosfomycin exposure during early pregnancy. However, larger studies are needed to confirm the safety of fosfomycin during the first trimester.

Background Among food pantry users there is a high prevalence of both smoking and food insecurity, which may be related to one another. This study aims to evaluate the impact of a smoking cessation program carried out in food pantries on the smoking status and the food security status of food pantry users. Methods / design Before starting the cluster randomised controlled trial, stakeholders will be engaged to adapt a behavioural group counselling program for smoking cessation to the needs of the food pantry users in a pre study. Food pantry users and workers as well as other experts, such as smoking cessation trainers, social workers, and psychologists, will be involved, using the world café technique and telephone interviews and a qualitative thematic analysis for data analysis to design the concept of the intervention program will be applied. In the second phase, the impact of the intervention on the smoking status and on food insecurity will be investigated by a cluster randomised controlled trial. A total of 416 food pantry users across 32 clusters (food pantries) in Berlin, Germany, should be recruited and randomly assigned to either the intervention group or the waiting list control group. The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries. The primary outcomes 6 months after the treatment will be self-reported continuous smoking abstinence, validated by exhaled carbon monoxide (< 10 ppm of carbon monoxide), and increased food security level (the percentage of participants with an improved food security level). Discussion This study will be the first long-term investigation into the effect of a smoking cessation program on smoking status and food insecurity. The results of this study will inform the implementation of smoking cessation programs in food pantries throughout Germany. Trial registration Prospectively registered DRKS00020037 . Registered 29 April 2020

Non-pharmaceutical interventions (NPI) such as facemasks and intensified hand hygiene may be effective in preventing influenza infections in households. It may be equally important that household members, especially children, can learn to use, maintain and tolerate these measures. We monitored adherence and tolerability of these NPI within a cluster-randomized trial in households with influenza index patients. We recruited 147 participants in 41 households, 39 (95%) out of 41 index patients were children (aged <14 years). In households assigned to wear facemasks, their use peaked on day 4 after symptom onset of the index patient at 73% and at 65% for children and adults, respectively. Mean daily frequency of hand disinfection in households assigned to intensified hand hygiene measures peaked at 7·7 (day 6) for children and at 10·1 (day 5) for adults. The majority of participants reported no problems with mask wearing. Data suggest that usage of NPI can be taught and that measures are well tolerated by adults and even sick children alike.

Infection by the new corona virus strain SARS-CoV-2 and its related syndrome COVID-19 has been associated with more than two million deaths worldwide. Patients of higher age and with preexisting chronic health conditions are at an increased risk of fatal disease outcome. However, detailed information on causes of death and the contribution of pre-existing health conditions to death yet is missing, which can be reliably established by autopsy only. We performed full body autopsies on 26 patients that had died after SARS-CoV-2 infection and COVID-19 at the Charité University Hospital Berlin, Germany, or at associated teaching hospitals. We systematically evaluated causes of death and pre-existing health conditions. Additionally, clinical records and death certificates were evaluated. We report findings on causes of death and comorbidities of 26 decedents that had clinically presented with severe COVID-19. We found that septic shock and multi organ failure was the most common immediate cause of death, often due to suppurative pulmonary infection. Respiratory failure due to diffuse alveolar damage presented as immediate cause of death in fewer cases. Several comorbidities, such as hypertension, ischemic heart disease, and obesity were present in the vast majority of patients. Our findings reveal that causes of death were directly related to COVID-19 in the majority of decedents, while they appear not to be an immediate result of preexisting health conditions and comorbidities. We therefore suggest that the majority of patients had died of COVID-19 with only contributory implications of preexisting health conditions to the mechanism of death.

Background Hemophagocytic lymphohistiocytosis (HLH) is a rare though often fatal hyperinflammatory syndrome mimicking sepsis in the critically ill. Diagnosis relies on the HLH-2004 criteria and HScore, both of which have been developed in pediatric or adult non-critically ill patients, respectively. Therefore, we aimed to determine the sensitivity and specificity of HLH-2004 criteria and HScore in a cohort of adult critically ill patients. Methods In this further analysis of a retrospective observational study, patients ≥ 18 years admitted to at least one adult ICU at Charité – Universitätsmedizin Berlin between January 2006 and August 2018 with hyperferritinemia of ≥ 500 μg/L were included. Patients’ charts were reviewed for clinically diagnosed or suspected HLH. Receiver operating characteristics (ROC) analysis was performed to determine prediction accuracy. Results In total, 2623 patients with hyperferritinemia were included, of whom 40 patients had HLH. We found the best prediction accuracy of HLH diagnosis for a cutoff of 4 fulfilled HLH-2004 criteria (95.0% sensitivity and 93.6% specificity) and HScore cutoff of 168 (100% sensitivity and 94.1% specificity). By adjusting HLH-2004 criteria cutoffs of both hyperferritinemia to 3000 μg/L and fever to 38.2 °C, sensitivity and specificity increased to 97.5% and 96.1%, respectively. Both a higher number of fulfilled HLH-2004 criteria [OR 1.513 (95% CI 1.372–1.667); p  <  0.001] and a higher HScore [OR 1.011 (95% CI 1.009–1.013); p  <  0.001] were significantly associated with in-hospital mortality. Conclusions An HScore cutoff of 168 revealed a sensitivity of 100% and a specificity of 94.1%, thereby providing slightly superior diagnostic accuracy compared to HLH-2004 criteria. Both HLH-2004 criteria and HScore proved to be of good diagnostic accuracy and consequently might be used for HLH diagnosis in critically ill patients. Clinical trial registration The study was registered with www.ClinicalTrials.gov ( NCT02854943 ) on August 1, 2016.

We tested 130 rats captured in Berlin for coronaviruses. SARS-CoV-2 antibodies were detected in 1 rat, but all animals were negative by reverse transcription PCR, suggesting SARS-CoV-2 was not circulating in the rat population. However, alphacoronaviruses were found. Monitoring rodent populations helps to determine coronavirus occurrence, transmission, and zoonotic potential.

BackgroundE-scooters have emerged as a frequently used vehicle in German cities due to their high availability and easy access. However, investigations about the causes and mechanisms of E-scooter incidents and their trauma-specific consequences are rare.MethodsWe analysed all patients involved in E-scooter incidents from June to December 2019 who presented to four inner-city EDs in Berlin. The prospective data included patient-related and incident-related data, information on injury patterns and therapy, responses in a voluntary questionnaire concerning E-scooter use and general traffic experience.Results248 patients (129 males; median age 29 years (5–81)) were included: 41% were tourists and 4% were children. Most incidents (71%) occurred between July and September 2019, the majority occurring at weekends (58%). The injury pattern was mostly multifocal, affecting the lower (42%) and upper limbs (37%) and the head (40%). Traumatic brain injury was associated with alcohol consumption. Inpatient admission was recorded in 25%, surgery in 23%.ConclusionThis study has defined the incidence of injury related to E-scooter use in a major European city. Stricter laws governing the use of E-scooters, the wearing of helmets and technical modifications to the E-scooter platforms might decrease E-scooter-associated incidents and resulting injuries in the future.Trial registration numberGerman Clinical Trials Registry (DRKS00018061).

Background Most studies agree that the Covid-19 pandemic and the subsequent lockdown had a negative impact on mental health. On the other hand, international studies have shown that psychiatric emergency departments (pED) experienced a decrease in presentations and admissions. Methods Retrospective chart review of all pED presentations and admissions during the first wave of Covid-19 pandemic in Germany (Covid-19 period: 3/2/20 to 05/24/20) in a psychiatric hospital in Berlin compared to 1 year earlier (pre-Covid-19 period). Descriptive statistics and logistic regression were performed. Results We observed no statistical significant changes in overall pED presentations and overall hospital admissions during the Covid-19 period compared to the pre-Covid-19 period (813 vs. 894, − 9.1%, p  = 0.064 and (363 vs. 437, − 16.9%, p  = 0.080 respectively). In the subgroup analysis, less patients with depressive disorders ( p  = 0.035) and with personality disorders ( p  = 0.002) presented to the pED, a larger number of presentations with schizophrenia was observed ( p  = 0.020). In the Covid-19 period, less patients with substance use disorder and paranoid schizophrenia were admitted to the hospital via the pED than in the pre-Covid-19 period ( p  = 0.035 and p  = 0.006, respectively). Bed capacity was reduced in the Covid-19 period by − 32.8% ( p  <  0.001). Presentations in police custody were 13.7% ( p  = 0.029) higher during the Covid-19 compared to pre-Covid-19 period, with higher rates in female presentations ( p  = 0.008) and suicide attempts ( p  = 0.012) and less hospital admissions ( p  = 0.048). Logistic regression analyses revealed that positive predictors for pED presentation during Covid-19 period were police custody ( p  <  0.001), being redirected from another hospital ( p  <  0.001), suicide attempt ( p  = 0.038), suicidal thoughts ( p  = 0.004), presentation with paranoid schizophrenia ( p  = 0.001) and bipolar and manic disorders ( p  = 0.004), negative predictors were hospital admission ( p  <  0.001), depressive disorders ( p  = 0.021) and personality disorders ( p  <  0.001). Conclusions A larger number of presentations in police custody during the Covid-19 period may represent untreated medical needs. This was seen predominantly in female patients, suggesting this subgroup might have suffered particularly under lockdown measures. Patients with paranoid schizophrenia were the only subgroup, which increased in absolute numbers, also suggesting a particular lockdown effect. Reduced bed capacity due to infection curbing measures is suggestive to have played an important role in augmenting the threshold for hospital admissions.

PurposeSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread worldwide causing a global health emergency. Pa-COVID-19 aims to provide comprehensive data on clinical course, pathophysiology, immunology and outcome of COVID-19, to identify prognostic biomarkers, clinical scores, and therapeutic targets for improved clinical management and preventive interventions.MethodsPa-COVID-19 is a prospective observational cohort study of patients with confirmed SARS-CoV-2 infection treated at Charité - Universitätsmedizin Berlin. We collect data on epidemiology, demography, medical history, symptoms, clinical course, and pathogen testing and treatment. Systematic, serial blood sampling will allow deep molecular and immunological phenotyping, transcriptomic profiling, and comprehensive biobanking. Longitudinal data and sample collection during hospitalization will be supplemented by long-term follow-up.ResultsOutcome measures include the WHO clinical ordinal scale on day 15 and clinical, functional, and health-related quality-of-life assessments at discharge and during follow-up. We developed a scalable dataset to (i) suit national standards of care, (ii) facilitate comprehensive data collection in medical care facilities with varying resources, and (iii) allow for rapid implementation of interventional trials based on the standardized study design and data collection. We propose this scalable protocol as blueprint for harmonized data collection and deep phenotyping in COVID-19 in Germany.ConclusionWe established a basic platform for harmonized, scalable data collection, pathophysiological analysis, and deep phenotyping of COVID-19, which enables rapid generation of evidence for improved medical care and identification of candidate therapeutic and preventive strategies. The electronic database accredited for interventional trials allows fast trial implementation for candidate therapeutic agents.Trial registrationRegistered at the German registry for clinical studies (DRKS00021688)

The COVID-19 pandemic and related restrictions have affected the wellbeing of schoolchildren worldwide, but the extent and duration of specific problems are still not completely understood. We aimed to describe students’ psychosocial and behavioral parameters and associated factors during the COVID-19 pandemic in Berlin, Germany. Our longitudinal study included 384 students from 24 randomly selected Berlin primary and secondary schools, assessing psychosocial wellbeing at four time points between June 2020 and March 2021. We analyzed temporal changes in the proportions of anxiety, fear of infection, reduced health-related quality of life (HRQoL), physical activity and social contacts, as well as sociodemographic and economic factors associated with anxiety, fear of infection and HRQoL. During the observation period, the presence of anxiety symptoms increased from 26.2% (96/367) to 34.6% (62/179), and fear of infection from 28.6% (108/377) to 40.6% (73/180). The proportion of children with limited social contacts (<1/week) increased from 16.4% (61/373) to 23.5% (42/179). Low physical activity (<3 times sports/week) was consistent over time. Low HRQoL was observed among 44% (77/174) of children. Factors associated with anxiety were female sex, increasing age, secondary school attendance, lower household income, and the presence of adults with anxiety symptoms in the student´s household. Fear of infection and low HRQoL were associated with anxiety. A substantial proportion of schoolchildren experienced unfavorable psychosocial conditions during the COVID-19 pandemic in 2020/2021. Students from households with limited social and financial resilience require special attention.