On Tuesday September 27th the University of Cologne (Uniklinik Köln, group of Maria Vehreschild & Oliver Cornely ) announced the enrollment of the first patient in the ANTICIPATE study.
On Tuesday September 27th the University of Cologne (Uniklinik Köln, group of Maria Vehreschild & Oliver Cornely ) announced the enrollment of the first patient in the ANTICIPATE study. Just recently on August 30th, site selection was finalized by selecting sites from France, Germany, Greece, Romania, Spain and the Netherlands for participation in the study.
The ANTICIPATE study in COMBACTE-NET is an observational study to determine the incidence of Clostridium difficile infections in hospitalized patients on antibiotic treatment. A total of 1.000 hospitalized patients aged ≥50 years old and undergoing predefined antibiotic treatment will be included. For this study we selected 30 qualified clinical sites in 6 European countries.
The results from this study will be used to design phase III randomized controlled trials (RCT) of DAV132, a product developed by Da Volterra, a new partner in COMBACTE-NET. DAV132 is to be co-administered with antibiotics and binds antibiotic residues in the large intestines, thereby preventing the side effects of antibiotics on the intestinal microbiota. The RCTs will aim to assess whether DAV132 prevents the occurrence of CDI in patients at risk of CDI receiving antibiotics and whether it protects the intestinal microbiota in patients under antibiotic treatment. To effectively design the RCTs, during ANTICIPATE we will collect high quality data on the incidence of CDI and AAD and on the impact of antibiotics on the diversity and composition of the intestinal microbiota.
The ANTICIPATE study in COMBACTE-NET is an observational study to determine the incidence of Clostridium difficile infections in hospitalized patients on antibiotic treatment. A total of 1.000 hospitalized patients aged ≥50 years old and undergoing predefined antibiotic treatment will be included. For this study we selected 30 qualified clinical sites in 6 European countries. The site selection process started on May 4th by sending out the first feasibility questionnaire. In total, 86 sites received a clinical feasibility questionnaire and 57 laboratories received a laboratory feasibility questionnaire. Of these sites, 39 completed both feasibility questionnaires and were considered for participation in the study. Ten sites refused participation in the site selection process because of several reasons. On August 30th, site selection was finalized by selecting the final site. Sites from France, Germany, Greece, Romania, Spain and the Netherlands were selected for participation in the study. In the race for the first local IRB approval Cologne defeated the Utrecht team on August 30th. Regulatory approval has also been obtained in France. We are planning to initiate the first sites before the end of September. We will keep you updated on the progress of the study and expect the first patients being enrolled soon.
The RESCUING study is a multinational, multicenter, retrospective observational study to assess the clinical management, outcomes and costs of hospitalized patients with cUTI in intensive care units and hospital wards and to identify the risk factors associated with treatment failure in this cohort of patients. The data was gathered from 20 hospitals located in 8 South and Eastern European countries and Israel with high prevalence of multidrug resistant Gram-negative bacteria. The data was collected retrospectively and about 30-80 cases of cUTI were included per center from patients hospitalized between January 2013 and December 2014.
A total of 1,009 evaluable cases have been collected with the final case entered on 17th July 2016. All queries were solved and the database was locked on 12th August 2016. The data has been exported and data analysis was started in August 2016. A statistical analysis group consisting of Academic and EFPIA members of this workpackage will meet periodically to discuss the data analysis results. Potential publications related to this workpackage are already being considered.
COMBACTE-CARE's Rejuvenate Study is progressing, with a total of 9 patients who were treated with ATM-AVI up until the end of August. Leading Center in recruitments is the University Hospital Virgen del Rocío in Seville (J. M. Cisneros Herreros & M.J. Hernández-Rodríguez) with 3 patients. While most patients are recruited in Spain, trial centers in France (Limoges University Hospital, Deborah Postil) and in Germany (University Hospital Cologne, Oliver Cornely) were able to contribute to the efforts, as well. At the moment 11 of 22 centers are opened with the rest of the centers to follow within September. This will allow the study to reach the threshold of 10 eligible patients for safety review, soon and will trigger the first meeting of the Scientific Advisory Committee (SAC).
The SAC will review the safety data and provide recommendations on the inclusion of patients with renal impairment and the introduction of a higher treatment dose. An amendment implementing these adaptations in the treatment is currently submitted to the regulatory authorities and ethics committees in Germany, France and Spain. The approvals are expected in October/November and will allow the REJUVENATE study to progress into the next stage.
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