COMBACTE-CARE's REJUVENATE is approaching the next big milestone: 9 of the 10 patients required for the early 10-patient-review have been recruited! Top recruiter with 4 treated patients is the University Hospital Virgen del Rocío in Seville, Spain.
REJUVENATE is approaching the next big milestone: 9 of the 10 patients required for the early 10-patient-review have been recruited! Top recruiter with 4 treated patients is the University Hospital Virgen del Rocío in Seville, Spain (principle investigator M.J. Hernández-Rodríguez). Upon completion of all safety and PK assessments of the 10th eligible patient the Scientific Advisory Comittee will convene and review safety data to assess and confirm the inclusion of patients with moderate renal impairment and investigation of a higher AVI dose. The REJUVENATE study protocol has been amended to incorporate these new dosing regimens and is currently under review by the regulatory authorities and Ethics committees in France, Germany and Spain. Final approvals are expected for late October and November 2016.
COMBACTE-NET's ASPIRE-SSI study, received ethical approval on Tuesday October 11th from the Dutch Medical Ethics and Review Committee and will begin recruiting patients in the Netherlands.
At this time, 4 of 20 sites (Netherlands (2), France (1), and Serbia (1)) have been selected. We aim to have the first site initiation visit and first patient enrolled in November 2016 with an estimated enrollment completion by April 2018.
If you would like to receive more information about the ASPIRE-SSI study, please send an email to the ASPIRE-SSI study team at ASPIRE-SSI@combacte.com.
On September 13th and 14th a delegation of the CLIN-Net (University Medical Centre Utrecht) and LAB-Net (University of Antwerp) team was in Sofia, Bulgaria for a country visit. The aim of these visits is to further consolidate the hospital and laboratory networks within COMBACTE, by meeting with the national coordinator(s) and visiting clinical and laboratory contacts.
The first day the teams met with Prof. Rossitza Vatcheva-Dobrevska, national coordinator for CLIN-Net as well as LAB-Net, and clinical microbiologist at the University Hospital Queen Joanna ISUL. This hospital participated in the now finalized RESCUING trial, is currently participating in the ASPIRE-ICU trial and in the site selection process for the ANTICIPATE trial. As national coordinator Prof. Vatcheva-Dobrevska’s plays a crucial role in being the first point of contact regarding clinical trial sites in Bulgaria.
Together with Prof. Vatcheva-Dobrevska, a meeting was hosted at the university clinic attended by 15 researchers from 5 of COMBACTE’s Bulgarian hospital and laboratory networks. An update was given on the clinical and laboratory network and ongoing and upcoming COMBACTE trials. The meeting also gave the opportunity to share thoughts on antimicrobial development and the specifics of performing clinical trials in Bulgaria.
While in Bulgaria, the team also conducted site visits at the University Hospital Queen Joanna ISUL, the University Hospital for Emergency Medicine N.I. Pirogov, and the St. Anna - University Multiprofile Hospital for Active Treatment.
The country and site visits have further strengthened the ties between COMBACTE and the Bulgarian network. Next steps will be adding the St. Anna hospital to our CLINICAL-Network, inviting them to participate in the ASPIRE-SSI trial, and organize a face-to-face Good Clinical Practice course in Bulgaria for our COMBACTE contacts.
We are already looking forward to meeting our colleagues during the next COMBACTE Country visit in Milan, Italy this October!
From left to right: Miquel Ekkelenkamp (CLIN-Net), Katina Kardamanidis (CLIN-Net), Rossitza Vatcheva-Dobrevska (national coordinator), Miranda Hopman (CLIN-Net), Tomislav Kostyanev (LAB-Net), Villi Dicheva.
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.
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