combacte-care Blog

A Day in the Hospital: Including Patients for REVISIT

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.

Meet the Team

Dr. Rosa Jiménez

Digestive Surgery Service and Principal Investigator of the REVISIT study

A Day in the Hospital: Including Patients for REVISIT
Dr. Manuel Poyato

Infectious Diseases Service and Study Coordinator of the REVISIT study

A Day in the Hospital: Including Patients for REVISIT 1

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.

After the surgery of the patient at 11 a.m, there is a new contact moment between Rosa and Manuel. They discuss the next steps for including the patient to the REVISIT trial.

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.

A Day at the Hospital: Including Patients for REVISIT

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.

A Day at the Hospital: Including Patients for REVISIT 1
30/05/2022

324 Subjects Randomized in REVISIT

20/01/2022

Recruitment for REVISIT in Progress

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