Evaluation of the effectiveness and safety of oral vancomycin versus placebo in the prevention of recurrence of Clostridioides difficile infection in patients under systemic antibiotic therapy: a phase III, randomised, double-blind clinical trial

infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a growing medical problem. Data from real-life studies and one open label randomised clinical trial (RCT) suggest that secondary prophylaxis with...

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Vydáno v:	BMJ open Ročník 13; číslo 9; s. e072121
Hlavní autoři:	San-Juan, Rafael, Origuen, Julia, Campion, Karen, Fernández-Ruiz, Mario, Diaz-Pollan, Beatriz, Callejas-Diaz, Alejandro, Candela, Giancarlo, Orellana, Maria Angeles, Lora, David, Llorente Muñoz, Irene, Garcia, Maria Teresa, Martinez-Uña, Maite, Ferrari, Jose Miguel, Aguado, Jose M
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	England BMJ Publishing Group LTD 13.09.2023 BMJ Publishing Group
Edice:	Protocol
Témata:	Adult Anti-Bacterial Agents - therapeutic use Antibiotics Clinical trials Clostridium Infections - prevention & control Diarrhea Disease prevention Double-blind studies Drug dosages Hospitals Hospitals, University Humans Infections Infectious Diseases Informed consent Medical ethics Microbiota Secondary Prevention Structured Query Language-SQL Vancomycin - therapeutic use United States > US gastrointestinal infections epidemiology infection control
ISSN:	2044-6055, 2044-6055
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Abstract	infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a growing medical problem. Data from real-life studies and one open label randomised clinical trial (RCT) suggest that secondary prophylaxis with oral vancomycin (SPV) during subsequent courses of systemic antibiotics is a promising approach for reducing the risk of CDI recurrence. Our aim is to confirm the role of SPV through a double-blind RCT. We will perform a phase III, multicentre, placebo-controlled RCT (PREVAN trial) in a 2:1 ratio in favour of SPV (experimental treatment), in four tertiary care hospitals in Spain. Adult patients (≥18 years) with a previous history of CDI in the previous 180 days and with requirement for hospitalisation and systemic antibiotic therapy will be randomly allocated to receive either 125 mg of oral vancomycin or placebo every 6 hours for 10 days. Patients will be followed for 60 days after the end of treatment to verify a reduction in the rate of CDI recurrence in the experimental group. We assume a recurrence rate of 5% in the experimental group versus 25% in the placebo group. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 104 subjects will be required in total (68 assigned to the SPV group and 34 to the placebo group). Ethical approval has been obtained from the Ethic Committee for Research with medicinal products of the University Hospital '12 de Octubre' (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), which is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders. NCT05320068.
AbstractList	Introduction Clostridioides difficile infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a growing medical problem. Data from real-life studies and one open label randomised clinical trial (RCT) suggest that secondary prophylaxis with oral vancomycin (SPV) during subsequent courses of systemic antibiotics is a promising approach for reducing the risk of CDI recurrence. Our aim is to confirm the role of SPV through a double-blind RCT.Methods and analysis We will perform a phase III, multicentre, placebo-controlled RCT (PREVAN trial) in a 2:1 ratio in favour of SPV (experimental treatment), in four tertiary care hospitals in Spain. Adult patients (≥18 years) with a previous history of CDI in the previous 180 days and with requirement for hospitalisation and systemic antibiotic therapy will be randomly allocated to receive either 125 mg of oral vancomycin or placebo every 6 hours for 10 days. Patients will be followed for 60 days after the end of treatment to verify a reduction in the rate of CDI recurrence in the experimental group. We assume a recurrence rate of 5% in the experimental group versus 25% in the placebo group. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 104 subjects will be required in total (68 assigned to the SPV group and 34 to the placebo group).Ethics and dissemination Ethical approval has been obtained from the Ethic Committee for Research with medicinal products of the University Hospital ‘12 de Octubre’ (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), which is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders.Trial registration number NCT05320068. IntroductionClostridioides difficile infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a growing medical problem. Data from real-life studies and one open label randomised clinical trial (RCT) suggest that secondary prophylaxis with oral vancomycin (SPV) during subsequent courses of systemic antibiotics is a promising approach for reducing the risk of CDI recurrence. Our aim is to confirm the role of SPV through a double-blind RCT.Methods and analysisWe will perform a phase III, multicentre, placebo-controlled RCT (PREVAN trial) in a 2:1 ratio in favour of SPV (experimental treatment), in four tertiary care hospitals in Spain. Adult patients (≥18 years) with a previous history of CDI in the previous 180 days and with requirement for hospitalisation and systemic antibiotic therapy will be randomly allocated to receive either 125 mg of oral vancomycin or placebo every 6 hours for 10 days. Patients will be followed for 60 days after the end of treatment to verify a reduction in the rate of CDI recurrence in the experimental group. We assume a recurrence rate of 5% in the experimental group versus 25% in the placebo group. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 104 subjects will be required in total (68 assigned to the SPV group and 34 to the placebo group).Ethics and disseminationEthical approval has been obtained from the Ethic Committee for Research with medicinal products of the University Hospital ‘12 de Octubre’ (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), which is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders.Trial registration numberNCT05320068. infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a growing medical problem. Data from real-life studies and one open label randomised clinical trial (RCT) suggest that secondary prophylaxis with oral vancomycin (SPV) during subsequent courses of systemic antibiotics is a promising approach for reducing the risk of CDI recurrence. Our aim is to confirm the role of SPV through a double-blind RCT. We will perform a phase III, multicentre, placebo-controlled RCT (PREVAN trial) in a 2:1 ratio in favour of SPV (experimental treatment), in four tertiary care hospitals in Spain. Adult patients (≥18 years) with a previous history of CDI in the previous 180 days and with requirement for hospitalisation and systemic antibiotic therapy will be randomly allocated to receive either 125 mg of oral vancomycin or placebo every 6 hours for 10 days. Patients will be followed for 60 days after the end of treatment to verify a reduction in the rate of CDI recurrence in the experimental group. We assume a recurrence rate of 5% in the experimental group versus 25% in the placebo group. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 104 subjects will be required in total (68 assigned to the SPV group and 34 to the placebo group). Ethical approval has been obtained from the Ethic Committee for Research with medicinal products of the University Hospital '12 de Octubre' (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), which is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders. NCT05320068. Clostridioides difficile infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a growing medical problem. Data from real-life studies and one open label randomised clinical trial (RCT) suggest that secondary prophylaxis with oral vancomycin (SPV) during subsequent courses of systemic antibiotics is a promising approach for reducing the risk of CDI recurrence. Our aim is to confirm the role of SPV through a double-blind RCT.INTRODUCTIONClostridioides difficile infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a growing medical problem. Data from real-life studies and one open label randomised clinical trial (RCT) suggest that secondary prophylaxis with oral vancomycin (SPV) during subsequent courses of systemic antibiotics is a promising approach for reducing the risk of CDI recurrence. Our aim is to confirm the role of SPV through a double-blind RCT.We will perform a phase III, multicentre, placebo-controlled RCT (PREVAN trial) in a 2:1 ratio in favour of SPV (experimental treatment), in four tertiary care hospitals in Spain. Adult patients (≥18 years) with a previous history of CDI in the previous 180 days and with requirement for hospitalisation and systemic antibiotic therapy will be randomly allocated to receive either 125 mg of oral vancomycin or placebo every 6 hours for 10 days. Patients will be followed for 60 days after the end of treatment to verify a reduction in the rate of CDI recurrence in the experimental group. We assume a recurrence rate of 5% in the experimental group versus 25% in the placebo group. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 104 subjects will be required in total (68 assigned to the SPV group and 34 to the placebo group).METHODS AND ANALYSISWe will perform a phase III, multicentre, placebo-controlled RCT (PREVAN trial) in a 2:1 ratio in favour of SPV (experimental treatment), in four tertiary care hospitals in Spain. Adult patients (≥18 years) with a previous history of CDI in the previous 180 days and with requirement for hospitalisation and systemic antibiotic therapy will be randomly allocated to receive either 125 mg of oral vancomycin or placebo every 6 hours for 10 days. Patients will be followed for 60 days after the end of treatment to verify a reduction in the rate of CDI recurrence in the experimental group. We assume a recurrence rate of 5% in the experimental group versus 25% in the placebo group. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 104 subjects will be required in total (68 assigned to the SPV group and 34 to the placebo group).Ethical approval has been obtained from the Ethic Committee for Research with medicinal products of the University Hospital '12 de Octubre' (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), which is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders.ETHICS AND DISSEMINATIONEthical approval has been obtained from the Ethic Committee for Research with medicinal products of the University Hospital '12 de Octubre' (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), which is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders.NCT05320068.TRIAL REGISTRATION NUMBERNCT05320068.
Author	Ferrari, Jose Miguel Campion, Karen Fernández-Ruiz, Mario Orellana, Maria Angeles Candela, Giancarlo Aguado, Jose M San-Juan, Rafael Callejas-Diaz, Alejandro Diaz-Pollan, Beatriz Llorente Muñoz, Irene Lora, David Garcia, Maria Teresa Origuen, Julia Martinez-Uña, Maite
AuthorAffiliation	5 Department of Internal Medicine , Puerta de Hierro University Hospital of Majadahonda , Majadahonda , Spain 4 Department of Internal Medicine , La Paz University Hospital , Madrid , Spain 6 Department of Internal Medicine , Severo Ochoa University Hospital , Leganes , Spain 3 Instituto de Investigacion Biomedica del Hospital Universitario 12 de Octubre , Madrid , Spain 7 Department of Microbiology , Hospital Universitario "12 de Octubre" , Madrid , Spain 9 SCREN , Fundacion para la Investigacion Biomedica del Hospital Universitario 12 de Octubre , Madrid , Spain 8 Clinical Research Unit (I+12) , Hospital Universitario 12 de Octubre , Madrid , Spain 1 Department of Infectious Diseases , Hospital Universitario "12 de Octubre" , Madrid , Spain 2 CIBERINFEC, ISCIII - CIBER de Enfermedades Infecciosas, Instituto de Salud Carlos III , Madrid , Spain 10 Department of Pharmacy , Hospital Universitario "12 de Octubre" , Madrid , Spain
AuthorAffiliation_xml	– name: 2 CIBERINFEC, ISCIII - CIBER de Enfermedades Infecciosas, Instituto de Salud Carlos III , Madrid , Spain – name: 3 Instituto de Investigacion Biomedica del Hospital Universitario 12 de Octubre , Madrid , Spain – name: 8 Clinical Research Unit (I+12) , Hospital Universitario 12 de Octubre , Madrid , Spain – name: 7 Department of Microbiology , Hospital Universitario "12 de Octubre" , Madrid , Spain – name: 1 Department of Infectious Diseases , Hospital Universitario "12 de Octubre" , Madrid , Spain – name: 6 Department of Internal Medicine , Severo Ochoa University Hospital , Leganes , Spain – name: 5 Department of Internal Medicine , Puerta de Hierro University Hospital of Majadahonda , Majadahonda , Spain – name: 4 Department of Internal Medicine , La Paz University Hospital , Madrid , Spain – name: 9 SCREN , Fundacion para la Investigacion Biomedica del Hospital Universitario 12 de Octubre , Madrid , Spain – name: 10 Department of Pharmacy , Hospital Universitario "12 de Octubre" , Madrid , Spain
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Snippet	infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a... IntroductionClostridioides difficile infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with... Clostridioides difficile infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The... Introduction Clostridioides difficile infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with...
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SubjectTerms	Adult Anti-Bacterial Agents - therapeutic use Antibiotics Clinical trials Clostridium Infections - prevention & control Diarrhea Disease prevention Double-blind studies Drug dosages Hospitals Hospitals, University Humans Infections Infectious Diseases Informed consent Medical ethics Microbiota Secondary Prevention Structured Query Language-SQL Vancomycin - therapeutic use
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Title	Evaluation of the effectiveness and safety of oral vancomycin versus placebo in the prevention of recurrence of Clostridioides difficile infection in patients under systemic antibiotic therapy: a phase III, randomised, double-blind clinical trial
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