Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2020/03/stewardship-resistance-scan-mar-02-2020
Stewardship / Resistance Scan for Mar 02, 2020
Antibiotics in non-severe infections; Combo antibiotic for resistant UTIs
Filed Under:
Antimicrobial Stewardship
[h=3]Study: Delaying antibiotics OK in mild to moderate bacterial infections[/h]
Withholding antibiotic therapy until diagnosis of bacterial infections (ie, 4 to 8 hours) seems acceptable in patients other than those who may have septic shock or bacterial meningitis and may be a sound antibiotic stewardship approach, according to a meta-analysis of 60 studies published in Clinical Microbiology and Infection.
European researchers explored the effect of time to antibiotic initiation on clinical outcomes in patients in emergency departments (EDs) who had bacterial infections of different severities and sources.
Initiating antibiotic treatment quickly—within 3 hours—is considered crucial in patients with severe bacterial infections such as septic shock and meningitis, but the researchers sought to better understand which patients could withstand delayed treatment in order to improve antibiotic stewardship. Many patients in the ED have common community-acquired infections caused by bacteria sensitive to narrow-spectrum antibiotics, the researchers wrote.
"We conclude that the literature supports prompt administration of effective antibiotics for septic shock and meningitis, but there is no clear evidence showing that a delayed start of therapy is associated with worse outcome for less severe infectious syndromes," the investigators said. "This approach promotes the use of ecologically favourable antibiotics in the ED, reducing the risks of side effects and selection of resistance."
The researchers, who found few studies in the literature on mild to moderate infections, called for stronger evidence from prospective clinical trials.
Feb 28 Clin Microbiol Infect abstract
[h=3]Combo antibiotic for resistant UTIs shows promise in phase 3 trial[/h]
French biopharmaceutical company Allecra Therapeutics announced last week that its investigational combination drug Exblifep met the US Food and Drug Administration and European Medicines Agency's pre-specified primary end point and demonstrated superiority over piperacillin-tazobactam in a phase 3 trial of patients who had complicated urinary tract infections (cUTIs).
The topline results from the phase 3 ALLIUM trial showed that the overall success of Exblifep in cUTI patients was 79.1%, compared with 58.9% for piperacillin-tazobactam. The primary end point in the randomized trial was a combination of clinical cure and microbiologic eradication. The drug was also well tolerated, with 4.3% of patients reporting adverse events, compared with 3.7% of piperacillin-tazobactam patients.
Exblifep is a combination of the novel beta-lactamase inhibitor enmetazobactam with the fourth-generation cephalosporin cefepime. It's intended for treatment of infections caused by multidrug-resistant strains of Enterobacteriaceae and Pseudomonas aeruginosa.
"The superiority demonstrated in the primary endpoint, at test of cure, combined with a comparable safety profile to that of well tolerated and widely used piperacillin-tazobactam support the potential use of cefepime-enmetazobactam as a new empiric and carbapenem- sparing treatment for multi-drug resistant Gram-negative infections," Allecra Chief Medical Officer Patrick Velicitat, MD, said in a company press release.
Feb 25 Allecra Therapeutics press release
Stewardship / Resistance Scan for Mar 02, 2020
Antibiotics in non-severe infections; Combo antibiotic for resistant UTIs
Filed Under:
Antimicrobial Stewardship
[h=3]Study: Delaying antibiotics OK in mild to moderate bacterial infections[/h]
Withholding antibiotic therapy until diagnosis of bacterial infections (ie, 4 to 8 hours) seems acceptable in patients other than those who may have septic shock or bacterial meningitis and may be a sound antibiotic stewardship approach, according to a meta-analysis of 60 studies published in Clinical Microbiology and Infection.
European researchers explored the effect of time to antibiotic initiation on clinical outcomes in patients in emergency departments (EDs) who had bacterial infections of different severities and sources.
Initiating antibiotic treatment quickly—within 3 hours—is considered crucial in patients with severe bacterial infections such as septic shock and meningitis, but the researchers sought to better understand which patients could withstand delayed treatment in order to improve antibiotic stewardship. Many patients in the ED have common community-acquired infections caused by bacteria sensitive to narrow-spectrum antibiotics, the researchers wrote.
"We conclude that the literature supports prompt administration of effective antibiotics for septic shock and meningitis, but there is no clear evidence showing that a delayed start of therapy is associated with worse outcome for less severe infectious syndromes," the investigators said. "This approach promotes the use of ecologically favourable antibiotics in the ED, reducing the risks of side effects and selection of resistance."
The researchers, who found few studies in the literature on mild to moderate infections, called for stronger evidence from prospective clinical trials.
Feb 28 Clin Microbiol Infect abstract
[h=3]Combo antibiotic for resistant UTIs shows promise in phase 3 trial[/h]
French biopharmaceutical company Allecra Therapeutics announced last week that its investigational combination drug Exblifep met the US Food and Drug Administration and European Medicines Agency's pre-specified primary end point and demonstrated superiority over piperacillin-tazobactam in a phase 3 trial of patients who had complicated urinary tract infections (cUTIs).
The topline results from the phase 3 ALLIUM trial showed that the overall success of Exblifep in cUTI patients was 79.1%, compared with 58.9% for piperacillin-tazobactam. The primary end point in the randomized trial was a combination of clinical cure and microbiologic eradication. The drug was also well tolerated, with 4.3% of patients reporting adverse events, compared with 3.7% of piperacillin-tazobactam patients.
Exblifep is a combination of the novel beta-lactamase inhibitor enmetazobactam with the fourth-generation cephalosporin cefepime. It's intended for treatment of infections caused by multidrug-resistant strains of Enterobacteriaceae and Pseudomonas aeruginosa.
"The superiority demonstrated in the primary endpoint, at test of cure, combined with a comparable safety profile to that of well tolerated and widely used piperacillin-tazobactam support the potential use of cefepime-enmetazobactam as a new empiric and carbapenem- sparing treatment for multi-drug resistant Gram-negative infections," Allecra Chief Medical Officer Patrick Velicitat, MD, said in a company press release.
Feb 25 Allecra Therapeutics press release