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Protocolo De Ensayo Clínico Con Medicamentos Protocol PROFTMDECOL Study CLINICAL RESEARCH PROTOCOL Open-label, randomized study to assess the efficacy of a probiotic or fecal microbiota transplantation (FMT) on the eradication of rectal multidrug-resistant Gram-negative bacilli (MDR-GNB) carriage Protocol: PROFTMDECOL Version: 1.0 (02/12/2019) Sponsor: Fundació Clínic per a la Recerca Biomèdica Principal Investigator: Dra. Ana Del Río. Co-principal Investigator: Dr. José Antonio Martínez. Infectious Diseases Hospital Clínic Villarroel, 170 08036 Barcelona Version 1.0 dated 02 December 2019 - 1 - Protocol PROFTMDECOL Study 1. Brief description 1.0. Study This is an investigator-initiated, single center, parallel-group, randomized, open-label, clinical research with non pharmacological products. 1.1. Sponsor Fundació Clínic per a la Recerca Biomédica. Rosselló, 149 08036 Barcelona 1.2. Study identification Title: Open-label, randomized study to assess the efficacy of a probiotic or fecal microbiota transplantation (FMT) on the eradication of rectal multidrug-resistant Gram-negative bacilli (MDR-GNB) carriage. Protocol code: PROFTMDECOL 1.4. Investigators Principal investigator: Dra. Ana Del Río, Infectious Diseases Co-principal investigator: Dr. José Antonio Martínez, Infectious Diseases Collaborators: Dr. C. Pitart, Microbiología Clínica Dr. J. Mercadal, Anestesiología Dra. E. López, Farmacia Hospitalaria 1.5. Clinical sites Single centre study: Hospital Clínic, Barcelona 1.6. Ethics approval The protocol, informed consent form, and other required documents will be approved by the Ethics Committee (Comité de Ética de la Investigación, CEI) of the Hospital Clínic de Barcelona before enrolment of subjects in the study. 1.7. Monitoring Dr. JA Arnaiz, Unidad de Ensayos Clínicos (CTU Clinic) Farmacología Clínica, Hospital Clínic, Barcelona. 1.8. Treatments Eligible subjects will be randomly assigned to one of the two intervention arms (probiotic or fecal microbiota transplantation product) or to a control non-intervention (observation) arm in a 2:2:1 proportion. Version 1.0 dated 02 December 2019 - 2 - Protocol PROFTMDECOL Study a) Probiotic (Vivomixx® 2 sachets/12h for 2 weeks) b) Fecal microbiota transplantation: administration of two doses (administered a week apart) of a fecal microbiota transplantation preparation (14-17 oral capsules per dose equivalent to 50 g of healthy-donor feces) c) No treatment (Observation) 1.9. Primary objective To compare the decolonization efficacy at the end of the study (60 ± 7 days after randomization) 1.10. Study population Patients with rectal colonization with MDR-GNB (ESBL-producing Klebsiella pneumoniae, CPE and MDR/XDR Pseudomonas aeruginosa). 1.11. Subject selection Inclusion criteria Male and female patients who meet all the following criteria will be eligible for this study: 1. Adult patients (≥18 years-old). 2. Admitted to the Hospital Clinic of Barcelona with documented rectal colonization whitin the previous 7 days by rectal swabbing with MDR-GNB (ESBL-producing Klebsiella pneumoniae, carbapenemase-producing Enterobacterial (CPE) and MDR/XDR Pseudomonas aeruginosa). 3. Eligible for routine digestive decolonization (7 days oral administration of nonabsorbable antibiotics (NAA). 4. Capable to provide informed consent (by themselves or through their legal representatives). Exclusion criteria Patients meeting any of the following criteria will not be eligible for the study: 1. Pregnant women or breastfeeding. 2. Neutropenic patients (total neutrophil count <500 cell/mm3)*. 3. HIV-infected patients with CD4 count <200 cell/mm3. 4. Patients with active C. difficile infection. 5. Patients with ileus or bowel obstruction. 6. Patients with documented or suspected bowel perforation. 7. Patients with a colistin-resistant MDR-GNB. 1.12. Assessment Decolonization rate at the end of the study (60 ± 7 days after randomization). Decolonization defined as a negative rectal swab sample for the target MDR-GNB at 60 ± 7 days after randomization. Version 1.0 dated 02 December 2019 - 3 - Protocol PROFTMDECOL Study 1.13. Allocation participant A total of 437 eligible subjects will be randomly assigned to one of the two intervention arms (175 patients to probiotic, 175 to fecal microbiota transplantation product) or to a control non- intervention arm (87 patients). Randomization will be stratified by the type of microorganism (ESBL-K. pneumoniae, CPE and MDR-P. aeruginosa) to ensure a balanced number of each organism in the study arms. 1.14. Follow-up Patients follow-up will be carried out 60 days (± 7 days) after randomization. 1.15. End of the clinical research The end of the clinical research is defined as the date of the last visit of last subject undergoing the study with a recruiment period of 30 months. Version 1.0 dated 02 December 2019 - 4 - Protocol PROFTMDECOL Study 2. TABLE OF CONTENTS 1. RESUMEN ........................................................................................................................................................... 2 1.0. Tipo de solicitud .............................................................................................................................................. 2 1.1. Identificación del promotor ............................................................................................................................ 2 1.2. Título del estudio ............................................................................................................................................ 2 1.3. Código del protocolo ........................................................................................ ¡Error! Marcador no definido. 1.4. Investigador coordinador e investigadores principales .................................................................................. 2 1.5. Centros en los que se prevé realizar el ensayo ............................................................................................... 2 1.6. Comités Éticos de Investigación que han aprobado el ensayo ....................................................................... 2 1.7. Responsable de la monitorización .................................................................................................................. 2 1.8. Productos en investigación ............................................................................................................................. 2 1.9. Objetivo principal ........................................................................................................................................... 3 1.10. Enfermedad en estudio ................................................................................................................................ 3 1.11. Criterios de inclusión y exclusión .................................................................................................................. 3 1.12. Variable principal de valoración ................................................................................................................... 3 1.13. Población en estudio y número total de pacientes ...................................................................................... 4 1.14. Duración del tratamiento ........................................................................................................................... 4 1.15. Calendario y fecha prevista de finalización .................................................................................................. 4 2. TABLE OF CONTENTS ......................................................................................................................................... 5 3. GENERAL INFORMATION ................................................................................................................................... 7 3.1. Study identification ......................................................................................................................................... 7 3.2. Investigators ................................................................................................................................................... 7 3.3. Clinical sites .................................................................................................................................................... 7 3.4. Sponsor ........................................................................................................................................................... 7 3.5. Monitoring ...................................................................................................................................................... 7 3.6. Study duration ................................................................................................................................................ 7 4. BACKGROUND, RATIONALE AND OBJECTIVES ................................................................................................... 8 4.1. Background and rationale............................................................................................................................... 8 4.2. Objectives of the study ................................................................................................................................. 11 4.2.1. Primary objective ................................................................................................................................... 11 4.2.2. Secondary objectives ............................................................................................................................
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