Shiloh
Editor, Senior Moderator
Source: https://www.cidrap.umn.edu/news-perspective/2020/10/news-scan-oct-29-2020
News Scan for Oct 29, 2020
Two E coli outbreaks; Phase 3 data for oral carbapenem; H5N8 avian flu in Netherlands
Filed Under:
E coli; Foodborne Disease; Antimicrobial Stewardship; Avian Influenza (Bird Flu)
Two E coli outbreaks with unknown causes total 44 cases, 1 death
Yesterday the Centers for Disease Control and Prevention (CDC) reported two separate Escherichia coli O157:H7 outbreaks in the United States. Neither has an identified source, and one has already proved deadly.
The first outbreak has had 21 cases reported from Jun 6 to Oct 5 across eight states, the most being in California (7) and Ohio (7). So far, there have been eight hospitalizations, including 1 case of hemolytic uremic syndrome (HUS), a type of kidney failure, and 1 death.
The patients range from 2 to 75 years of age, with a median of 24 years. While no common source has been identified, officials discovered an illness cluster spreading from a restaurant.
The other E coli outbreak has 23 cases thus far reported from Aug 17 through Oct across 12 states, with Kansas and North Dakota both having 4 cases, followed by California, Michigan, Missouri, Pennsylvania, and Wisconsin with 2 cases each. Ages range from 5 to 81 years, with a median of 21.
Of the 15 people with further information available, 10 needed hospitalization and 2 have or had HUS. All 13 people interviewed to date reported eating leafy greens, including iceberg lettuce (9), spinach (9), romaine lettuce (8), and mixed bag lettuce (6).
Both outbreaks' strains have been linked to separate romaine lettuce outbreaks in the past, the first having the same strain as a 2018 outbreak and the second having the same as one in 2019, but no conclusions can be made from this, the CDC says. The agency advises people to practice extra hygiene and caution when preparing and cooking food, to avoid unpasteurized products, and to wash hands after using the restroom, changing diapers, and interacting with animals.
Currently, the agency is conducting interviews with the ill, and the US Food and Drug Administration (FDA) is investigating food sources, samples, and trace-backs.
Oct 28 CDC outbreak investigation notice A
Oct 28 CDC outbreak investigation notice B
Promising phase 3 data for oral carbapenem presented at IDWeek
Data from a phase 3 trial presented last week at IDWeek 2020 by researchers from Spero Therapeutics show that oral tebipenem was comparable in safety and efficacy to intravenous (IV) ertapenem for treating complicated urinary tract infections (cUTIs) and acute pyelonephritis (AP).
In the double-blind phase 3 study, which was conducted at more than 100 hospitals in 15 countries, 1,372 hospitalized patients who had cUTIs or AP were randomized to receive either oral tebipenem pivoxil hydrobromide (TBP-PI-HBr) or IV ertapenem for 7 to 10 days. The primary end point was overall response (composite clinical cure and microbiologic eradication) at the test-of-cure visit on Day 19. The non-inferiority margin was -12.5%.
The results showed that oral TBP-PI-HBr met the primary objective of non-inferiority compared with IV ertapenem, with an overall response rate of 58.8% (264 of 449 patients) versus 61.6% (258/419) for IV ertapenem (treatment difference, -3.3%; 95% confidence interval [CI], -9.7% to 3.2%). Clinical cure rates were greater than 93% in both treatment groups, and microbiologic response rates for target uropathogens were comparable.
Treatment-emergent adverse events were observed in 25.7% of TBP-PI-HBr patients and 25.6% of IV ertapenem patients, and most were mild. Serious adverse events were infrequent in both groups (1.3% for TBP-PI-HBr patients vs 1.7% for IV ertapenem patients).
Spero Therapeutics said earlier this month that it plans to submit a new drug application for TBP-PI-HBr to the FDA in the second quarter of 2021. If approved, it would be the first oral carbapenem to receive approval in the United States.
Oct 24 IDWeek 2020 abstract
Oct 16 Spero Therapeutics press release
H5 avian flu detected at Netherlands broiler farm
The Dutch government today reported a highly pathogenic H5 avian flu outbreak at a broiler farm near the village of Altforst in Gelderland province in the east central part of the country.
No other poultry facilities are within a 1 km radius of the facility, and culling is underway among 35,700 birds at the farm. Sampling is being conducted in other poultry flocks in the greater area.
Last week, Dutch veterinary officials reported H5N8 in two mute swans found dead in Utrecht province. Over the past few months, Russia and Kazakhstan have reported a small but steady stream of H5N8 outbreaks, and the UK government has warned of the threat of the virus spreading from migratory birds to poultry.
Oct 29 Dutch government statement
News Scan for Oct 29, 2020
Two E coli outbreaks; Phase 3 data for oral carbapenem; H5N8 avian flu in Netherlands
Filed Under:
E coli; Foodborne Disease; Antimicrobial Stewardship; Avian Influenza (Bird Flu)
Two E coli outbreaks with unknown causes total 44 cases, 1 death
Yesterday the Centers for Disease Control and Prevention (CDC) reported two separate Escherichia coli O157:H7 outbreaks in the United States. Neither has an identified source, and one has already proved deadly.
The first outbreak has had 21 cases reported from Jun 6 to Oct 5 across eight states, the most being in California (7) and Ohio (7). So far, there have been eight hospitalizations, including 1 case of hemolytic uremic syndrome (HUS), a type of kidney failure, and 1 death.
The patients range from 2 to 75 years of age, with a median of 24 years. While no common source has been identified, officials discovered an illness cluster spreading from a restaurant.
The other E coli outbreak has 23 cases thus far reported from Aug 17 through Oct across 12 states, with Kansas and North Dakota both having 4 cases, followed by California, Michigan, Missouri, Pennsylvania, and Wisconsin with 2 cases each. Ages range from 5 to 81 years, with a median of 21.
Of the 15 people with further information available, 10 needed hospitalization and 2 have or had HUS. All 13 people interviewed to date reported eating leafy greens, including iceberg lettuce (9), spinach (9), romaine lettuce (8), and mixed bag lettuce (6).
Both outbreaks' strains have been linked to separate romaine lettuce outbreaks in the past, the first having the same strain as a 2018 outbreak and the second having the same as one in 2019, but no conclusions can be made from this, the CDC says. The agency advises people to practice extra hygiene and caution when preparing and cooking food, to avoid unpasteurized products, and to wash hands after using the restroom, changing diapers, and interacting with animals.
Currently, the agency is conducting interviews with the ill, and the US Food and Drug Administration (FDA) is investigating food sources, samples, and trace-backs.
Oct 28 CDC outbreak investigation notice A
Oct 28 CDC outbreak investigation notice B
Promising phase 3 data for oral carbapenem presented at IDWeek
Data from a phase 3 trial presented last week at IDWeek 2020 by researchers from Spero Therapeutics show that oral tebipenem was comparable in safety and efficacy to intravenous (IV) ertapenem for treating complicated urinary tract infections (cUTIs) and acute pyelonephritis (AP).
In the double-blind phase 3 study, which was conducted at more than 100 hospitals in 15 countries, 1,372 hospitalized patients who had cUTIs or AP were randomized to receive either oral tebipenem pivoxil hydrobromide (TBP-PI-HBr) or IV ertapenem for 7 to 10 days. The primary end point was overall response (composite clinical cure and microbiologic eradication) at the test-of-cure visit on Day 19. The non-inferiority margin was -12.5%.
The results showed that oral TBP-PI-HBr met the primary objective of non-inferiority compared with IV ertapenem, with an overall response rate of 58.8% (264 of 449 patients) versus 61.6% (258/419) for IV ertapenem (treatment difference, -3.3%; 95% confidence interval [CI], -9.7% to 3.2%). Clinical cure rates were greater than 93% in both treatment groups, and microbiologic response rates for target uropathogens were comparable.
Treatment-emergent adverse events were observed in 25.7% of TBP-PI-HBr patients and 25.6% of IV ertapenem patients, and most were mild. Serious adverse events were infrequent in both groups (1.3% for TBP-PI-HBr patients vs 1.7% for IV ertapenem patients).
Spero Therapeutics said earlier this month that it plans to submit a new drug application for TBP-PI-HBr to the FDA in the second quarter of 2021. If approved, it would be the first oral carbapenem to receive approval in the United States.
Oct 24 IDWeek 2020 abstract
Oct 16 Spero Therapeutics press release
H5 avian flu detected at Netherlands broiler farm
The Dutch government today reported a highly pathogenic H5 avian flu outbreak at a broiler farm near the village of Altforst in Gelderland province in the east central part of the country.
No other poultry facilities are within a 1 km radius of the facility, and culling is underway among 35,700 birds at the farm. Sampling is being conducted in other poultry flocks in the greater area.
Last week, Dutch veterinary officials reported H5N8 in two mute swans found dead in Utrecht province. Over the past few months, Russia and Kazakhstan have reported a small but steady stream of H5N8 outbreaks, and the UK government has warned of the threat of the virus spreading from migratory birds to poultry.
Oct 29 Dutch government statement