Why participation in an international clinical trial platform matters during a pandemic? Launching REMAP-CAP in Japan

REMAP-CAP, a randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia, is an international clinical trial that is rapidly expanding its scope and scale in response to the COVID-19 pandemic. Japan is now joining REMAP-CAP with endorsement from Japanese academic societies. Commitment to REMAP-CAP can significantly contribute to population health through timely identification of optimal COVID-19 therapeutics. Additionally, it will promote the establishment of a national and global network of clinical trials to tackle future pandemics of emerging and re-emerging infectious diseases, in collaboration with multiple stakeholders, including front-line healthcare workers, governmental agencies, regulatory authorities, and academic societies.

Home parenteral nutrition with an omega-3 fatty acid enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): Study protocol for a randomized, controlled, multicenter, international clinical trial

Background Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenous lipid emulsions (ILEs) are an essential component of HPN providing energy and essential fatty acids, but can become a risk factor for intestinal failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited.Methods The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem / Lipoplus ® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin ® MCT/LCT / Medialipide ® 20%, B. Braun Melsungen AG) for a projected period of eight weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of safety and tolerability as well as the efficacy of the ILEs.Discussion Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The aim of the HOME study is to demonstrate that the n-3 PUFA enriched ILE is safe and well tolerated especially with regard to liver function in patients requiring HPN. The study will provide data from a considerable number of CIF patients and thus contribute to broaden the present evidence on the use of ILEs in HPN.

Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial

Background Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenously administered lipid emulsions (ILEs) are an essential component of HPN, providing energy and essential fatty acids, but can become a risk factor for intestinal-failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited. Methods/design The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG) for a projected period of 8 weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of the safety and tolerability as well as the efficacy of the ILEs. Discussion Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN. Trial registration ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.

Home parenteral nutrition with an omega-3 fatty acid enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): Study protocol for a randomized, controlled, multicenter, international clinical trial

Background Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenous lipid emulsions (ILEs) are an essential component of HPN providing energy and essential fatty acids, but can become a risk factor for intestinal failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited.Methods The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem / Lipoplus ® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin ® MCT/LCT / Medialipide ® 20%, B. Braun Melsungen AG) for a projected period of eight weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of safety and tolerability as well as the efficacy of the ILEs.Discussion Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The aim of the HOME study is to demonstrate that the n-3 PUFA enriched ILE is safe and well tolerated especially with regard to liver function in patients requiring HPN. The study will provide data from a considerable number of CIF patients and thus contribute to broaden the present evidence on the use of ILEs in HPN.Trial registrationClinicalTrials.gov, NCT03282955, registered on September 14, 2017