RESCUING is a REtrospective observational Study to assess the clinical management and outcomes of hospitalized patients with cUTI in countries with high prevalence of MDR Gram-negative bacteria.
For the publication in BMJ Open please read more here.
LAB-Net organized its first National coordinators meeting. National coordinators from 10 countries (Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Germany, Kosovo, Macedonia, Montenegro, the Netherlands and Spain) joined the event which was held in Antwerp, Belgium on 28th June, 2016. The participants had the opportunity to find out more about the structure of COMBACTE and its two network pillars, CLIN-Net and LAB-Net, as well as to present their own national laboratory networks. More information was given to the LAB-Net national coordinators about the future plans and goals of LAB-Net, as well as the upcoming activities in 2016. Roles and responsibilities of the national coordinators were defined followed by a discussion on the topic. The participants were also briefed on the External quality assessment programme of LAB-Net and the plans to deliver Good clinical laboratory practice training to the local labs in the network.
Since May 19th, a total of 6 patients have been enrolled in the REJUVENATE Study. Five patients were treated with ATM-AVI, with one screening failure. So far, all patients were enrolled in Spain at the University Hospital Virgen del Rocío, Seville (J. M. Cisneros Herreros & M.J. Hernández-Rodríguez), the Hospital Universitario Virgen Macarena, Seville (J. Rodríguez-Baño & L. Tallón-Aguilar), and the University of Cordoba (J. de la Torre Cisneros). As of now, 13 of 22 participating sites are initiated. Six sites are active and pre-screening and enrolling patients: 1 in France, 2 in Germany, and 3 sites in Spain. The remaining sites await activation following contract execution, and/or will be initiated and activated in July and August. The WP2A team is now working on achieving the next major milestones for REJUVENATE - the early safety and PK assessment of the first 10 patients that complete all study assessments. This review will support dose selection for the remainder of the Phase II study, including an appropriate dose for inclusion of patients with moderate renal impairment and confirmation of the dose to take forward into the Phase III study (WP2B). At the current recruitment rate inclusion of the 10th patient is expected in August, and 10-patient-review during September 2016.
Due to the hard work of all the participating sites, site staff, monitors and the study team, all the 1000 cases required for the RESCUING study have been collected. This Marks a very important milestone in this study.
The number of collected cases by the participating countries are depicted in the table below.
#of cases collected
The majority of close-out visits are now scheduled and the goal is to obtain the database lock by the end of July. Going forward, the plan is to analyze the data over the summer with a target completion date by the end of September 2016. It is hoped that the study report will be available during October 2016.
If you have any questions or comments about this study, please feel free to contact the study lead Miguel Pujol using the following email address: email@example.com