COMBACTE-NET. Update on ANTICIPATE Study Vienna, Austria MARIA J.G.T. VEHRESCHILD UNIVERSITY HOSPITAL COLOGNE, GERMANY

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1 COMBACTE-NET Update on ANTICIPATE Study Vienna, Austria MARIA J.G.T. VEHRESCHILD UNIVERSITY HOSPITAL COLOGNE, GERMANY

2 WP7 Overview ANTICIPATE clinical study: AssessmeNT of the Incidence of Clostridium difficile Infections in hospitalised Patients on Antibiotic TrEatment. European, hospital-based, prospective, observational 30 investigational sites to enrol 1000 patients Key Stake-holders: UMCU, DAV, UKK, UA Objectives: Collect high quality data to determine: patient population at risk of CDI incidence of CDI and AAD impact of antibiotics on the diversity and composition of the intestinal microbiota. Outputs expected: To draw innovative design for interventional phase III RCT: To demonstrate the efficacy and safety of DAV132 (new product of Da Volterra) in prevention of CDI 2

3 Description of DAV132 DAV132 is an oral product Designed to be combined with any oral or parenteral (i.e. injectable) antibiotic Presenting as tiny beads, packed in a sachet and to be suspended in water Composed of: An adsorbent, activated charcoal, specifically selected to adsorb efficiently and irreversibly a wide range of antibiotics DAV132 A special coating allowing delivery of activated charcoal in the ileo-caecal (lower) part of the intestine, when ph increases to Da Volterra IP ~ 0.6 mm ANTICIPATE SIV V

4 WP7 Major Achievements Milestones Actual date Operational Kick off meeting 20 Mar 16 Protocol Finalized 12 May 16 1 st Feasibility Questionnaire sent 04 May 16 Final list of selected sites * 31 Aug 16 1 st submission to EC 30 May weeks 1 st EC approval 31 Aug 16 1 st Site Initiation Visit 16 Sep Web-based Site Initiation Visits 1 st Patient In 27 Sep 16 Recruitment is ongoing 13 Apr patients screened, 305 patients enrolled, in 19 sites * Site selection via Clin-Net & Lab-Net: 11 countries / 86 sites and 57 labs: received a feasibility questionnaire Of these, 39 completed both feasibility questionnaires 30 sites selected from France; Germany, Greece, Netherland, Spain and Romania 4

5 3 Central laboratories Central & National laboratories Detection of C. difficile asymptomatic carriage: Institute for Medical Microbiology, University of Cologne Evaluation of intestinal microbiota,16s rrna gene profiling: Laboratory of Medical Microbiology, University of Antwerp, Evaluation of 3-indoxyl sulfate in urine: Eurofins central Lab, Breda 6 national laboratories CDI diagnostic tests: CHUL, Limoges (France) UKK, Cologne (Germany) UMCU, Utrecht (The Netherlands) Infectious and Tropical Diseases Hospital Dr. Victor Babes, Bucharest (Romania) Hospital Universitari de Bellvitge, Barcelona (Spain) University Hospital of Heraklion (Greece) ANTICIPATE SIV V4.0 5

6 ANTICIPATE: 6 countries / 34 sites in Europe Legend National Lab City 2 City 3 Utrecht Köln Aachen Essen Heidelberg Jena Leipzig Lubeck Munich Bucharest x2 Lasi Cluj-Napoca 2x Limoges Paris x4 Quimper Tours La Roche sur Yon Barcelona x2 ANTICIPATE SIV V8.0 Madrid x3 Sevilla Cordoba Heraklion Athens x 4 6

7 WP7 Patient recruitment is ongoing 7

8 WP7 Issues / Risks / Challenges / Lessons Learned Delay for site activation & recruitment: Initial plan: 100% sites active at the end of Year 2016 Completion of recruitment expected: End of Feb 2017 To date: 80% sites are active LPI date delayed Mitigation plan: Back-up sites identified and being initiated Initiation of meetings / TC to share experience on recruitment Lessons Learned: Results from feasibility questionnaires are crucial to identify bottlenecks: contracts issues ++ Country / Site specific regulatory requirements recruitment capacities at sites Building an efficient team between Academic and EFPIA partners is essential. 8

9 WP7 Looking Ahead Activities and goals in the next period (2017) to move the WP7 objectives forward: Completion of ANTICIPATE enrolment Meeting of coordinating parties in May to share first results of analysis on antibiotic-induced intestinal dysbiosis (assessed by 16S rrna) and discuss further methods of analysis Statistical analyses of study Dissemination of results Development of Phase III interventional study protocol with DAV132 9

10 WP7 Update Questions? 10