Tag Archives: c. diff.

C. diff. Infection and Sepsis Overview During a One Year Follow Up

Sepsis was a common Clostridioides difficile infection (C diff) complication throughout a 12-month follow-up period and was most commonly observed in the cohort of patients with 3 or more C diff infection recurrences, according to a paper published in SAGE Open Medicine.

Investigators from around New England conducted a retrospective analysis of more than 46,000 adult patients with C diff infection in order to evaluate the clinical complications of C diff in patients with index and recurrent cases. The investigators used the IQVIA PharMetrics Plus database to looks for patients aged 18-64 years with an index C diff episode that required inpatient stay or an outpatient visit, followed by a treatment for the infection. Treatments included vancomycin, fidaxomicin, metronidazole, rifaximin, or bezlotoxumab, or fecal microbiota transplant (FMT – though it was rare).

Each infection ended after a 14-day C diff-free period was observed, leaving recurrent C diff to be defined as further infection within an 8-week window for a period of 12 months.

To read the article in its entirety please click on the following link to be redirected:

https://www.hcplive.com/view/sepsis-among-common-c-diff-complications-during-one-year-follow-up-period

A total of 3129 patients (6.7%) experienced 1 recurrence, while 1% had 2 recurrences, and 0.3% had 3 or more recurrences. The study authors also noted that autoimmune diseases, such as ulcerative colitis, Crohn’s disease, type 1 diabetes, rheumatoid arthritis, and multiple sclerosis, were present in 18%, 23%, 24%, and nearly 40% of patients, respectively, in patients with 0, 1, 2, or 3 or more C diff infection recurrences.

Antibiotics were prescribed for three-quarters of all patients in all groups in the 6 months preceding the index C diff infection, the investigators found. Gastric acid-suppressing agents were prescribed in 28%, 33%, 39%, and 38%, respectively, in patients with 0, 1, 2, or 3 or more C diff infection recurrences, the study authors also noted.

Vancomycin was used to treat about a third of all index C diff infection patients, while metronidazole was used to treat a little more than half of the patients, the study authors wrote. Fidaxomicin was used to treat about 4% of patients. Vancomycin was the most commonly prescribed antibiotic used in recurrent C diff cases, with 55% of patients getting the antibiotic for the first recurrence, 56% getting it for their second recurrence, and 60% getting it for their third recurrence.

During the 12-month follow-up period, the investigators observed sepsis in 16%, 27%, 33%, and 43%, respectively, in patients with 0, 1, 2, or 3 or more C diff infection recurrences. No patient had more than 2 sepsis episodes during the 12-month follow-up period. Additionally, subtotal colectomy or diverting loop ileostomy was performed in 4%, 7%, 9%, and 10% of patients, respectively, in patients with 0, 1, 2, or 3 or more C diff infection recurrences.

“Our findings indicate that, among patients with more recurrent C diff infection, there was a parallel trend for higher rates of colectomy and sepsis,” the study authors wrote.

The study authors also said that patients with 3 or more recurrences also had the highest health care resource utilization and total, all-cause, direct medical costs of all the recurrence cohorts. Sepsis was highest among this group with the most recurrences, and the study authors hypothesized that this was due to having more opportunities to suffer from this type of adverse outcome.

“Reduction in recurrent C diff infection may be an important step to reduce the burden of serious clinical complications,” they concluded.

Sepsis Resources: 

https://www.global-sepsis-alliance.org/

https://www.sepsis.org/

 

Proton-Pump Inhibitors and Increased Risk of C. diff. Infections

 

 

 

 

 

Increased risk for Clostridium difficile (C diff) infection remained elevated for up to a year after the conclusion of treatment with proton-pump inhibitors (PPIs), according to a paper published in Clinical Infectious Diseases.

Malin Inghammar, PhD

Source and to read the article in its entirety please click on the following link to be redirected:

https://www.hcplive.com/view/elevated-risk-c-diff-proton-pump-inhibitor-use

Investigators from Copenhagen, Denmark used a nationwide cohort of adults with
a C diff infection in order to compare periods with and without exposure to PPIs. The adults were all treated between February 2010 and December 2013. The nationwide database included health information such as C diff testing, filled prescriptions, and patient characteristics. The investigators also accounted for the previous hospitalization in the previous 12 weeks in the patients, in addition to chronic disease, genetics, socioeconomic status, length of hospital stay, and antibiotic and corticosteroid use.

Ultimately, the study authors identified 3583 episodes of community-acquired C diff infection, of which 964 occurred during the current use of PPIs. This is an observation in the current literature, but what wasn’t understood was the full extent of the relationship due to missing data from randomized controlled trials, variability between studies, and insufficient adjustment for confounding.

“While a history of prior hospital admission, advanced age, and antibiotic use are well-known risk factors for C diff infection, the role of PPIs has remained controversial,” the study authors wrote.

The investigators defined new PPI use as a new prescription for individuals who had not used PPI in the prior 365 days. They split up the periods of 0-6 months and 6-12 months because in the first period, cessation was considered indeterminate use because of the possibility for intermittent use or drug exposure continuing beyond the use period. Exposure during the 6-12 month period was “unlikely.”

Of the infections that occurred with the use of PPIs, 324 occurred within 0-6 months after treatment conclusion. Additionally, 123 cases occurred between 6 and 12 months after treatment cessation.

The remainder of C diff infection cases occurred during time periods without use of PPIs, the investigators said.

Comparing the use of PPIs with nonuse, the study authors found that the adjusted estimate incidence rate ratio (IRR) was 2.03, they said. But the risk remained elevated in later time periods too: 1.54 for 0-6 months and 1.24 for 6-12 months.

“In conclusion, in this nationwide study in Denmark, we showed that exposure to PPIs was associated with a moderate increase in the risk of community-acquired C diff infection,” the study authors said while noting that the mechanism by which PPIs may increase the C diff infection risk remains unclear. “The increased risk was most prominent during current PPI use but also persisted after treatment discontinuation.”

One limitation the study authors provided for was that initial symptoms of C diff infection could have been misinterpreted and patients prescribed PPIs could not be excluded. But, they also admitted, “it is unlikely that this would lead to biased results because the symptoms of C diff infection (diarrhea) are distinct from the upper gastrointestinal symptoms that represent the most common indication for PPIs.”

MGB Biopharma Developing MGB-BP-3 a Treatment for CDI – Announces the Successful Completion of Its End-of-Phase 2 Meeting With the FDA

MGB Biopharmaa biopharmaceutical company developing MGB-BP-3, a novel antibacterial, for the treatment of Clostridioides difficile (CDI), today announces the successful completion of its End-of-Phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA), an important milestone for the company and its lead product.

The EOP2 Meeting is a formal step at which companies seek confirmation that their product is considered safe to proceed to broader clinical studies and to explore any additional studies that may be required before entering into Phase 3.

At the meeting, the US FDA confirmed that the design and the endpoints of our two prospective Phase 3 studies were appropriate. The Phase 3 studies, which are expected to recruit approximately 900 patients, will include the superiority of MGB-BP-3 against vancomycin in the critical measure of sustained clinical response as one of their endpoints.

Dr Miroslav Ravic, CEO of MGB Biopharma, said, “The successful completion of the End-of-Phase 2 meeting with the FDA marks the culmination of solid scientific and clinical endeavor by the Company. The positive Phase 2 data showed that MGB-BP-3 provides high rates of Sustained Cure from CDI, a devastating disease.  We are very pleased with the guidance received from the FDA on key elements of the Phase 3 program that will support the submission of a New Drug Application (NDA).

“The global pandemic caused by COVID-19 has highlighted the importance of being adequately prepared for infectious diseases. CDI’s ongoing high mortality reminds us that this is a disease with a significant unmet medical need for which new treatments are urgently required. MGB-BP-3, with its unique mode of action, is perfectly positioned to meet the need and provide confidence to patients and clinicians that more effective treatments are just round the corner.”

Professor Thomas Louie, clinical professor at the Cumming School of Medicine at the University of AlbertaCalgary (Canada) and Principal Investigator said, “I am most pleased to have contributed to the success of the Phase 2 clinical study of MGB-BP-3. There is a real need for new agents to address CDI and it is gratifying to see this agent progressing onto its next phase of the study. CDI represents a major burden to the Canadian and US healthcare systems. A novel antibiotic that is able to kill this deadly pathogen before it is able to sporulate offers hope to patients and their families who suffer the pain and misery caused by this disease.”

MGB Biopharma is considering strategic options for the business and has engaged JMP Securities as its exclusive financial advisor.

About MGB-BP-3

MGB-BP-3 is a novel antibiotic that belongs to the Minor Groove Binder group, discovered at the University of Strathclyde, with a unique rapid bactericidal activity against Clostridioides difficile (CDI), a feature shared by no other treatment available. A recently completed Phase 2 clinical study in 33 CDI patients using three sequential ascending doses of MGB-BP-3 showed a high initial average cure of 94% in all dosages, a high average sustained cure of 95% in the 2 lower dosages, and preservation of the gut microbiota with the lower dosages. There were correspondingly low recurrence rates of less than 5% for the first two doses. MGB-BP-3 was shown to be safe and well-tolerated with no serious adverse events in either of Phase 1 or 2 clinical studies.

CDI is a serious and life-threatening infection of the large intestine and is the most frequent cause of diarrhea in hospitals and care homes. In the US alone, there are almost half a million cases every year associated with around 30,000 deaths; three people die of uncontrolled CDI each hour. CDI has been recognized as an urgent threat pathogen by the Centers for Disease Control and Prevention (CDC) in the US and is a common consequence of antibiotic treatment in hospitalized patients.

About MGB Biopharma

MGB Biopharma is a clinical-stage company developing a novel class of anti-infectives. Its lead candidate, MGB-BP-3, is an antibacterial that is active against a broad range of important multi-resistant and susceptible Gram-positive pathogens. The Company is developing an oral formulation of MGB-BP-3 for the treatment of Clostridioides difficile Infection (CDI).

In addition to its C. difficile programme, MGB Biopharma has a pipeline of early preclinical compounds against Gram-positive, Gram-negative, anti-fungal, anti-viral and anti-parasitic pathogens.

MGB Biopharma acquired rights to the proprietary minor groove binder (MGB) platform, developed at the University of StrathclydeGlasgow, with exclusive worldwide licensing rights for all anti-infective fields. This platform provides an opportunity to develop various compounds with a completely new mode of action that are distinct from the antimicrobial drugs used in clinical practice today. As a result, many MGB-based drugs could have the potential to offer significant advantages over existing anti-infectives.

The Company, founded in 2010 and headquartered in Glasgow, Scotland, is backed by Scottish investors including Archangel Investors Limited, Barwell, TRICAPITAL, Syndicate Room, and the Scottish Investment Bank, Scottish Enterprise. The company also received significant support for its clinical programme from Innovate UK.

For more information, please visit www.mgb-biopharma.com

Air Fryer Chicken Recipe

Ingredients:

1 to 4 Chicken Breasts (skinless/boneless)

2 tsp Olive Oil

1/4 tsp Salt – as desired

1/4 tsp Pepper – as desired

1/4 tsp Garlic Powder 

To Prepare:

  1. Brush the chicken pieces with olive oil.
  2. Sprinkle one side with salt, pepper, as desired. Spices can be omitted or replaced with spices of choice.
  3. Place the breast in the air fryer basket seasoned side down. Then season the other side.
  4. Cook at 360° for 9 minutes (for 8 oz chicken breast). Then flip the chicken breast over and cook for another 9 minutes. Larger chicken breasts need more cook time, and smaller ones need less time. Always use a meat thermometer to check the internal temperature.
  5. Open the air fryer immediately so it doesn’t continue cooking in the heat.
  6. * Food Safety: Check the internal temperature by placing the instant-read meat thermometer in the thickest part of each piece of chicken. The temperature should read 158°-160° F. If it is below that, close the lid of the air fryer to let the chicken cook in the residual heat for a few minutes (2 to 4 additional minutes). Then check it again with the meat thermometer.
  7. Place chicken pieces on a plate and loosely cover with foil and let it rest for 5 minutes. It will continue to cook in the residual heat (and the juices will go back into the meat). Then after 5 minutes take the temperature again. The internal temperature should not be below 165° F.
  8. Serve immediately, or prepare left-over pieces of chicken to be placed in the refrigerator immediately to be served within two days. Left-over chicken pieces can also be prepared for other recipes (e.g. chicken soup, chicken salad, chicken and pasta).

Additional Cooking Notes:

Air Fryer Chicken Breast Cook Temp & Times
Turn chicken pieces over halfway through cook time
(Your model and size of the air fryer may vary from this slightly)

Please check your Air Fryer Manual for cooking time and instructions.

Average Cooking Temperature and Times:
6 oz chicken breast 360° for 15 minutes
8 oz chicken breast 360° for 18 minutes
10 oz chicken breast 360° for 20 minutes

When cooking multiple chicken breasts at once, use the average weight of the chicken pieces added together.