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Source: https://www.cidrap.umn.edu/news-pers...an-jun-05-2020
Stewardship / Resistance Scan for Jun 05, 2020
Combination antibiotic for hospital pneumonia; AMR surveillance network
Filed Under:
Antimicrobial Stewardship
FDA approves combo antibiotic for hospital-acquired, ventilator-associated pneumonia
Pharmaceutical company Merck announced today that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application for the antibacterial combination drug Recarbrio to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by gram-negative pathogens.
Recarbrio is a combination of the antibiotic imipenem-cilastatin and the beta-lactamase inhibitor relebactam. It was approved by the FDA in July 2019 to treat patients who have complicated urinary tract infections and intra-abdominal infections with no alternative treatment options.
The additional indication in HABP/VABP is based on the results of a phase 3 clinical trial—RESTORE-IMI—that compared outcomes in 535 HABP/VABP patients treated with either 1.25 grams of Recarbrio or 4.5 grams of piperacillin/tazobactam administered intravenously every 6 to 7 hours for 7 to 14 days. Recarbrio met the primary and key secondary endpoints in the trial, showing non-inferiority to piperacillin/tazobactam in 28-day all-cause mortality and clinical response at early follow-up.
"At a time of great public health concern about the need for new treatments to meet the evolving challenges posed by Gram-negative bacteria, we are proud to continue bringing new therapeutic options to health care practitioners in an effort to help them overcome the challenges in patient care,” Nicholas Kartsonis, MD, senior vice president of clinical research, infectious diseases and vaccines at Merck Research Laboratories, said in a company press release.
The company cautions that to reduce the development of antibiotic-resistant bacteria and maintain the effectiveness of the drug, Recarbrio should only be used to treat infections caused by susceptible bacteria.
Jun 5 Merck press release
New global antimicrobial resistance surveillance network launches
The International Society for Infectious Diseases and the Program for Monitoring Emerging Diseases (ProMED) yesterday announced a new global antimicrobial resistance (AMR) surveillance network, according to a ProMED-mail post.
The ProMED-AMR surveillance network will collect new information on antibiotic-resistant pathogens using digital disease detection methods and non-traditional sources, and a global team of AMR experts will vet, analyze, and comment on that information. The network will also produce and disseminate reports on trends, new cases, and clusters of AMR to an international audience in real time.
"The primary goal of ProMED-AMR is to build global public health capacity to rapidly detect and validate the occurrence of antimicrobial resistant pathogens in animals, humans, and the environment to help prevent further AMR expansion," ProMED-mail editor Larry Madoff, MD, said in the post. "ProMED-AMR will engage the international infectious diseases community in a forum for the exchange of ideas, information, and commentary relating to AMR and increase the knowledge base of effective and safe medicines to prevent and treat infectious diseases."
ProMED-AMR will be led by Matt Levison, MD, ProMED associate editor and an infectious disease specialist.
Jun 5 ProMed-mail post
Stewardship / Resistance Scan for Jun 05, 2020
Combination antibiotic for hospital pneumonia; AMR surveillance network
Filed Under:
Antimicrobial Stewardship
FDA approves combo antibiotic for hospital-acquired, ventilator-associated pneumonia
Pharmaceutical company Merck announced today that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application for the antibacterial combination drug Recarbrio to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by gram-negative pathogens.
Recarbrio is a combination of the antibiotic imipenem-cilastatin and the beta-lactamase inhibitor relebactam. It was approved by the FDA in July 2019 to treat patients who have complicated urinary tract infections and intra-abdominal infections with no alternative treatment options.
The additional indication in HABP/VABP is based on the results of a phase 3 clinical trial—RESTORE-IMI—that compared outcomes in 535 HABP/VABP patients treated with either 1.25 grams of Recarbrio or 4.5 grams of piperacillin/tazobactam administered intravenously every 6 to 7 hours for 7 to 14 days. Recarbrio met the primary and key secondary endpoints in the trial, showing non-inferiority to piperacillin/tazobactam in 28-day all-cause mortality and clinical response at early follow-up.
"At a time of great public health concern about the need for new treatments to meet the evolving challenges posed by Gram-negative bacteria, we are proud to continue bringing new therapeutic options to health care practitioners in an effort to help them overcome the challenges in patient care,” Nicholas Kartsonis, MD, senior vice president of clinical research, infectious diseases and vaccines at Merck Research Laboratories, said in a company press release.
The company cautions that to reduce the development of antibiotic-resistant bacteria and maintain the effectiveness of the drug, Recarbrio should only be used to treat infections caused by susceptible bacteria.
Jun 5 Merck press release
New global antimicrobial resistance surveillance network launches
The International Society for Infectious Diseases and the Program for Monitoring Emerging Diseases (ProMED) yesterday announced a new global antimicrobial resistance (AMR) surveillance network, according to a ProMED-mail post.
The ProMED-AMR surveillance network will collect new information on antibiotic-resistant pathogens using digital disease detection methods and non-traditional sources, and a global team of AMR experts will vet, analyze, and comment on that information. The network will also produce and disseminate reports on trends, new cases, and clusters of AMR to an international audience in real time.
"The primary goal of ProMED-AMR is to build global public health capacity to rapidly detect and validate the occurrence of antimicrobial resistant pathogens in animals, humans, and the environment to help prevent further AMR expansion," ProMED-mail editor Larry Madoff, MD, said in the post. "ProMED-AMR will engage the international infectious diseases community in a forum for the exchange of ideas, information, and commentary relating to AMR and increase the knowledge base of effective and safe medicines to prevent and treat infectious diseases."
ProMED-AMR will be led by Matt Levison, MD, ProMED associate editor and an infectious disease specialist.
Jun 5 ProMed-mail post