https://www.cidrap.umn.edu/news-perspective/2022/09/stewardship-resistance-scan-sep-23-2022
Stewardship / Resistance Scan for Sep 23, 2022
Fecal transplant therapy for C diff;
C diff risk in dialysis patients
Filed Under:
Antimicrobial Stewardship;
Clostridium difficile
FDA advisers approve fecal transplant treatment for recurrent C difficile
Swiss biopharmaceutical company Ferring Pharmaceuticals announced yesterday that the Food and Drug Administration's (FDA's) Vaccine and Related Biologic Products Advisory Committee (VRBPAC) voted in favor of the company's investigational fecal microbiota transplant (FMT)-based therapy.
According to a company press release, VRBPAC voted 13 to 4 that the data from the biologics license application were adequate to support the effectiveness of RBX2660 (Rebyota) to reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment, and 12 to 1 that the data were adequate to support safety of the microbiota-based live therapeutic treatment, which is delivered via an enema.
FMT therapy involves transplanting beneficial bacteria into the gut of a patient with recurrent CDI, which is traditionally treated with antibiotics. FMT has been found in several studies to be an effective treatment for recurrent CDI, and the most recent treatment guidelines from the Infectious Diseases Society of America recommend it for patients who've had several bouts of recurrent CDI and have not been cured by antibiotics.
Up to 35% of CDI cases recur after initial diagnosis, and patients who have recurrent CDI have a significantly higher risk of further infection.
"Today's advisory committee vote represents an important milestone in Ferring's ongoing efforts to address the unmet need for interventions that can reduce the incidence of recurrent C. difficile infection, which represents a significant health burden for patients," Mirjam Mol-Arts, MD, executive vice president and chief medical officer of Ferring Pharmaceuticals, said in the release.
RBX2660 would be the first FMT therapy approved by the FDA.
Sep 22 Ferring Pharmaceuticals press release
Hemodialysis patients have fourfold higher C diff risk, study finds
A systematic review and meta-analysis found that chronic kidney disease patients who require maintenance hemodialysis (MHD) have a significantly increased risk of CDI compared to those who don't require MHD, researchers reported today in Infection Control & Hospital Epidemiology.
To evaluate the burden of and potential risk factors for CDI in MHD patients, who are known to be at increased risk for CDI because of substantial antibiotic exposure and frequent hospitalizations, Brown University researchers reviewed 240 studies published prior to March 2022; 15 of these studies provided data on CDI rates among people requiring MHD, and 8 of them also provided CDI rates among people not requiring MHD.
The pooled prevalence of CDI among persons requiring MHD was 19.14%, compared with 5.16% among persons not requiring MHD (odds ratio [OR], 4.35; 95% confidence interval [CI], 2.07 to 9.16). The linear increase in CDI over time for both groups was significant, increasing an average of 31.97% annually from 1993 to 2017 (OR, 1.32; 95% CI, 1.1 to 1.58). The linear annual increase was similar among persons requiring and not requiring MHD (OR, 1.28; 95% CI, 1.13 to 1.45).
Risk factors specific to the MHD population included being 65 years of age or older, serum albumin levels of 3 grams per deciliter or lower, higher Charlson comorbidity index scores, HIV, and bloodstream infections. Mortality associated with CDI was double among people requiring MHD, and the case-fatality rate ranged from 13.2% to 68.8%.
"The substantially higher and rising rates of CDI among persons requiring MHD and associated higher morbidity and mortality compared to persons not requiring MHD both emphasize the importance of preventing C. difficile spread and CDI in this patient population," the authors wrote.
Sep 23 Infect Control Hosp Epidemiol study
Stewardship / Resistance Scan for Sep 23, 2022
Fecal transplant therapy for C diff;
C diff risk in dialysis patients
Filed Under:
Antimicrobial Stewardship;
Clostridium difficile
FDA advisers approve fecal transplant treatment for recurrent C difficile
Swiss biopharmaceutical company Ferring Pharmaceuticals announced yesterday that the Food and Drug Administration's (FDA's) Vaccine and Related Biologic Products Advisory Committee (VRBPAC) voted in favor of the company's investigational fecal microbiota transplant (FMT)-based therapy.
According to a company press release, VRBPAC voted 13 to 4 that the data from the biologics license application were adequate to support the effectiveness of RBX2660 (Rebyota) to reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment, and 12 to 1 that the data were adequate to support safety of the microbiota-based live therapeutic treatment, which is delivered via an enema.
FMT therapy involves transplanting beneficial bacteria into the gut of a patient with recurrent CDI, which is traditionally treated with antibiotics. FMT has been found in several studies to be an effective treatment for recurrent CDI, and the most recent treatment guidelines from the Infectious Diseases Society of America recommend it for patients who've had several bouts of recurrent CDI and have not been cured by antibiotics.
Up to 35% of CDI cases recur after initial diagnosis, and patients who have recurrent CDI have a significantly higher risk of further infection.
"Today's advisory committee vote represents an important milestone in Ferring's ongoing efforts to address the unmet need for interventions that can reduce the incidence of recurrent C. difficile infection, which represents a significant health burden for patients," Mirjam Mol-Arts, MD, executive vice president and chief medical officer of Ferring Pharmaceuticals, said in the release.
RBX2660 would be the first FMT therapy approved by the FDA.
Sep 22 Ferring Pharmaceuticals press release
Hemodialysis patients have fourfold higher C diff risk, study finds
A systematic review and meta-analysis found that chronic kidney disease patients who require maintenance hemodialysis (MHD) have a significantly increased risk of CDI compared to those who don't require MHD, researchers reported today in Infection Control & Hospital Epidemiology.
To evaluate the burden of and potential risk factors for CDI in MHD patients, who are known to be at increased risk for CDI because of substantial antibiotic exposure and frequent hospitalizations, Brown University researchers reviewed 240 studies published prior to March 2022; 15 of these studies provided data on CDI rates among people requiring MHD, and 8 of them also provided CDI rates among people not requiring MHD.
The pooled prevalence of CDI among persons requiring MHD was 19.14%, compared with 5.16% among persons not requiring MHD (odds ratio [OR], 4.35; 95% confidence interval [CI], 2.07 to 9.16). The linear increase in CDI over time for both groups was significant, increasing an average of 31.97% annually from 1993 to 2017 (OR, 1.32; 95% CI, 1.1 to 1.58). The linear annual increase was similar among persons requiring and not requiring MHD (OR, 1.28; 95% CI, 1.13 to 1.45).
Risk factors specific to the MHD population included being 65 years of age or older, serum albumin levels of 3 grams per deciliter or lower, higher Charlson comorbidity index scores, HIV, and bloodstream infections. Mortality associated with CDI was double among people requiring MHD, and the case-fatality rate ranged from 13.2% to 68.8%.
"The substantially higher and rising rates of CDI among persons requiring MHD and associated higher morbidity and mortality compared to persons not requiring MHD both emphasize the importance of preventing C. difficile spread and CDI in this patient population," the authors wrote.
Sep 23 Infect Control Hosp Epidemiol study