The University Hospital of Virgen del Rocío (Seville, Spain) is an active site in COMBACTE-CARE. From 2016 to 2018, the hospital included patients for the Phase II REJUVENATE study. By including 20% of the total number of patient, they were the 2nd biggest site on patient including. Since 2020, the hospital includes patients for the Phase III REVISIT trial. For this trial a smooth collaboration between surgeons and the infectious disease clinical unit is needed. Dr. Rosa Jiménez and Dr. Manuel Poyato show us how things are going at the Virgen del Rocío.
Digestive Surgery Service and Principal Investigator of the REVISIT study
Infectious Diseases Service and Study Coordinator of the REVISIT study
It's 8 a.m. at the Virgen del Rocío Hospital. Rosa and Manuel are discussing the potential candidates for the inclusion in the REVISIT clinical trial
Manuel: “Good morning Rosa, do we have any REVISIT candidate to include?.”
Rosa: “Hi! Good morning, I think we could have one for today, right now the patient is undergoing surgery, I will let you know as soon as I confirm he has a peritonitis.”
Manuel: “Perfect, let me know the patient ID when available in order to check the inclusion and exclusion criteria, we should be ready!
Since 2016 on every Monday to Friday morning, both teams have evaluated potential patients for the inclusion in the ATM-AVI clinical trials. Since 2020, this tandem “surgery- infectious diseases” started the evaluation for potential subjects for the REVISIT study in which more than 100 patients have been already evaluated and 10 patients included, positioning themselves in the top three sites worldwide with the best recruitment results.
Rosa: “The patient had a peritonitis and sample was taken.”
Manuel: “What time do we meet to explain the study to the patient and get the informed consent?”
Rosa. “The patient is now in the recovery room. I think we could meet once the patient is completely awake.“
The close collaboration continues with the presentation of the study to the patients. Both professionals discuss the study with the patient, preferably in the presence of her/his relatives, jointly solving any doubts that may arise. As targeted patients undergo a surgical intervention, the surgeon will be the patient’s reference. They will gain the patient’s trust during their daily visits for the length of the study. The active involvement of the surgeon and infectious disease expert during the explanation of the study improves the patient’s acceptance rates.
At 1 p.m. Rosa and Manuel leave the patient, who agreed to participate in the REVISIT trial. After signing the informed consent, Manuel activates the circuits implemented with the rest of the services involved in the study, an optimal formula in smoothly performing the numerous and complex patient procedures (IMP administration, samples collection, PK / PD, ECG, etc).
Rosa: “Microbiology has just confirmed that they have received the baseline intra-abdominal sample from the patient.”
Manuel: “Great!I am already organizing the IP administration schedule with the nursing and pharmacy colleagues.”
Rosa: “Ok, well we keep in touch to follow up the patient. Anything you need you tell me.”
Working closely together allows the site to perform a real-time patient evaluation improving its efficiency in a key process in this type of antimicrobial studies, characterized by their complexity in terms of patient identification and site organizational aspects (for the inclusion of a patient, approximately 10 potential candidates need to be evaluated).
The REVISIT multidisciplinary team also includes a nursing team, microbiology experts, the pharmacy and an academic clinical research and clinical trials unit. Watch the video highlighting the importance of teamwork in the successful recruitment of patients in the studies.
“The creation of multidisciplinary study teams in which Surgery and Infectious Diseases Services collaborate closely is the cornerstone for the success of the Spanish participation in COMBACTE projects within the ATM-AVI program characterized by their complexity in terms of patient identification and site organizational aspects. I want to acknowledge the excellent work of all the professionals from my hospital involved in those projects which are priority by its activity against carbapenemase-producing metallo-beta-lactamase-producing Enterobacteriaceae for which we currently lack optimal treatment”