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BACKGROUND: Clostridium difficile is the most common cause of infectious diarrhea in hospitalized patients. Recurrences are common after antibiotic therapy. Actoxumab and bezlotoxumab are human monoclonal antibodies against C. difficile toxins A and B, respectively.METHODS: We conducted two double-blind, randomized, placebo-controlled, phase 3 trials, MODIFY I and MODIFY II, involving 2655 adults receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection. Participants received an infusion of bezlotoxumab (10 mg per kilogram of body weight), actoxumab plus bezlotoxumab (10 mg per kilogram each), or placebo; actoxumab alone (10 mg per kilogram) was given in MODIFY I but discontinued after a planned interim analysis. The primary end point was recurrent infection (new episode after initial clinical cure) within 12 weeks after infusion in the modified intention-to-treat population.RESULTS: In both trials, the rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% [67 of 386] vs. 28% [109 of 395]; adjusted difference, -10.1 percentage points; 95% confidence interval [CI], -15.9 to -4.3; PCONCLUSIONS: Among participants receiving antibiotic treatment for primary or recurrent C. difficile infection, bezlotoxumab was associated with a substantially lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo. The addition of actoxumab did not improve efficacy. (Funded by Merck; MODIFY I and MODIFY II ClinicalTrials.gov numbers, NCT01241552 and NCT01513239 .).

Deliverable report D2.1 of the EU Horizon 2020 Project OPTAIN (Grant agreement No. 862756) To gather and organise the knowledge collected and created by OPTAIN on NSWRM, the Work Package 2 developed a catalogue of NSWRM. It presents each NSWRM considered in the project and contains all the associated information. The objective of D2.1 is to make qualitative and quantitative information on each specific measure available to various stakeholder groups, like all end users and NSWRM implementers. It enables to allow them to select, design and implement one or more NSWRM on their farm (or territory), or extract specific data and information they need for supporting the development and promotion of NSWRM use. Summary During the first reporting period of the H2020 project OPTAIN, the task 2.1 partners focused on framing the concept of Natural Small Water Retention Measures (NSWRM) and on identifying and documenting existing and underutilised NSWRM in all 14 case studies (CS) of the project. Therefore, a systematic approach was developed involving all relevant stakeholder groups in Multi Actor Reference Groups (MARG), comprising the following steps: identification of existing or potentially suitable measures, prioritisation of measures with a high potential in the local context of the different case studies, selection of a set of 3 to 7 measures per case study, which are relevant for the case studies and the OPTAIN project. Once the NSWRM have been selected, all case study implementers started to collect data on their individual measures and to document them by using the World Overview of Conservation Approaches and Technologies (WOCAT) questionnaire on Sustainable Land Management (SLM) Technologies, thus generating a standardised factsheet of each measure. All entered data on the WOCAT SLM database will then be linked to the Natural Water Retention Measure (NWRM) platform. The OPTAIN catalogue will be accessible from both websites as well as through the project’s own “Learning Environment” which will include a section dedicated to OPTAINs catalogue of NSWRM. Overall, the prioritization in the 14 case studies resulted in 66 selected NSWRM. The case study teams started documenting these selected NSWRM with the World Overview of Conservation Approaches and Technologies (WOCAT) Technology questionnaire, including description and classification, technical specification, implementation inputs and costs, natural and human environment, as well as ecological, socio-economic and socio-cultural impacts. To help in this process, a two-day virtual WOCAT training for all case study teams was organised and conducted by the task 2.1 team. In parallel, the task 2.1 partners conducted an analysis of the commonalities and differences between both WOCAT and NWRM.eu databases to provide an integrated view. The result of this analysis was d that there are only a few differences and a smooth integration could be possible. All entered data on the WOCAT global SLM database (https://qcat.wocat.net) will thus be linked to the NWRM platform (http://nwrm.eu/).

Deliverable report D2.2 of the EU Horizon 2020 Project OPTAIN (Grant agreement No. 862756). List of tailored and case-specific performance indicators (environmental and socio-economical) that help to evaluate the effectiveness of NSWRM monitored (existing measures) and modelled (potential future measures) in the OPTAIN case studies as well as used to establish a common language across project members and activities and to facilitate the knowledge sharing with stakeholders and the wider dissemination of project results. Summary: The content of this deliverable addresses the activities of the task 2.2 “Identification of performance indicators for the selected NSWRM” within the H2020 project OPTAIN. The core purpose of the task is to develop a customized set of indicators that allow assessing the effectiveness of selected (either existing or potential future) Natural/Small Water Retention Measures (NSWRMs) in and across the OPTAIN case studies (CS). The relevance of specific NSWRMs to face local challenges, their multifunctional nature and the manifold impacts they may have in the territory require identifying key elements that easily resume such features, while being flexible and adaptable enough to be used in different contexts. Therefore, task 2.2 elaborated a pathway to produce a list of Performance Indicators (PI), to set the focus for model parametrisation at different scales as well as to ensure an appropriate model setup and utilisation of modelling outcomes (WP4, WP5). For this reason, the screening, selection and tailoring of the most relevant indicators, to be used as PI, have been conducted from both the environmental (EPIs) and socio-economic (SPIs) points of view. The selection process was built at the interface between science and society, in a fruitful process of knowledge co-creation and sharing. As such, agreed lists of indicators can be used to support the harmonized approach of OPTAIN by establishing a common language across project members and activities, favour the understanding and the comparison of modelling results across CS, facilitating the dialogue with stakeholders and the wider dissemination of project results. The methodology followed to outline the customized list of indicators, to be used as PIs, was based upon the initial contribution of scientific / academic partners’ expertise to compile all the potential or candidate indicators and preselect the most relevant ones for the selected NSWRMs. As a result, we ended up with short lists of both environmental (25) and socio-economic (17) indicators that cover the most relevant issues of the OPTAIN case studies. In the second instance a participative approach involved local research teams and stakeholders in the valuation, adjustment and prioritisation of the most important indicators, also owing to the intensive consultation with OPTAINs Multi-Actor-Reference Groups (MARG). Based on the feedback obtained, the task 2.2 partners conducted an analysis of the commonalities and differences between CSs and scales. This allowed drawing the conclusion that, despite CS are experiencing diverse challenges, the most important issues covered by the selected indicators, and priorities given are very similar. Finally, for comparison purposes across CSs, a common set of PIs is proposed, including first discussions on the best way to represent selected PIs based on monitoring and/or modelling results to be available in CS.