Bezlotoxumab (Zinplava)For Prevention of Recurrent C. Difficile Infection

MedicalResearch.com Interview with:
Richard Hengel, MD, FRCPC, FACP Atlanta ID Group
Richard Hengel, MD, FRCPC, FACP

Atlanta ID Group

MedicalResearch.com: What is the background for this study? How does Bezlotoxumab differ from other medications for recurrent C. difficile infections?

Response: Clostridium difficile infection (CDI) is now the most common hospital acquired infection in the United States, accounting for significant morbidity and mortality, not only in the US, but around the world. Despite standard antibiotic therapy targeting the Clostridium difficile bacterium directly, recurrent infection is common, occurring in a quarter to a third of patients, often frail individuals with other concurrent medical problems. These patients can have multiple recurrences leading to their progressive deterioration over time. Until recently, the only treatment for CDI included antibiotics. More recently, fecal microbiota transplant is a promising, but as yet, FDA unapproved therapy. Bezlotoximab is a new FDA approved treatment for recurrent Clostridium difficile infection (rCDI) that compliments standard antibiotics. Bezlotoxumab is a monoclonal antibody targeting toxin B produced by Clostridium difficile during CDI. In two large treatment trials, bezotoxumab, in addition to standard-of-care antibiotics, reduced the frequency of CDI recurrences from about 28% to about 18%. In this study, we set out to see if this new drug performed as well in actual clinical practice as it did in the published clinical trials.

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Hospital Onset Clostridium difficile Infections Increased With Electronic Sepsis Alerts

MedicalResearch.com Interview with:

Dr. Robert Hiensch MD Assistant Professor, Medicine, Pulmonary, Critical Care and Sleep Medicine Icahn School of Medicine at Mount Sinai

Dr. Hiensch

Dr. Robert Hiensch MD
Assistant Professor, Medicine, Pulmonary, Critical Care and Sleep Medicine
Icahn School of Medicine at Mount Sinai.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: New sepsis guidelines that recommend screening and early treatment for sepsis cases appear to have significant positive impacts on patient outcomes. Less research has been published on what potential side effects may result from these guidelines.

Antibiotics are a cornerstone of sepsis treatment and early antibiotic administration is strongly recommended.  We examined whether the introduction of an electronic based sepsis initiative changed antibiotic prescribing patterns at our hospital. Antibiotics, even when appropriate, contribute to hospital onset Clostridium difficile infections (HO CDIs).  While the authors do not dispute the importance of antibiotic administration in sepsis, it is valuable to know whether the sepsis initiative coincided with both increased antibiotic administration and HO CDIs.

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Clostridium difficile Infections In US Hospitals Doubled over Decade

Kelly R. Reveles, PharmD, PhD The University of Texas College of PharmacyMedicalResearch.com Interview with:
Kelly R. Reveles, PharmD, PhD
The University of Texas College of Pharmacy

Medical Research: What are the main findings of the study?

Dr. Reveles: Our study utilized data from the Centers for Disease Control and Prevention’s National Hospital Discharge Surveys. Patients were selected for this study if they were at least 18 years of age and had an International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for Clostridium difficile infection (CDI) (ICD-9-CM code 008.45). We found that Clostridium difficile infection incidence increased from 4.5 CDI discharges/1,000 total discharges in 2001 to 8.2 CDI discharges/1,000 total discharges in 2010. Mortality varied over the study period with peak mortality occurring in 2003 (8.7%) and the lowest rate occurring in 2009 (5.6%). Median hospital length of stay (LOS) was 8 days and remained stable over the study period. In summary, the incidence of Clostridium difficile infection in U.S. hospitals nearly doubled from 2001 to 2010, with little evidence of recent decline. Additionally, there does not appear to be a significant decline in mortality or hospital LOS among patients with Clostridium difficile infection.

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Decline in C. Difficile may be due to Decreased Antibiotic Exposure

MedicalResearch.com Interview with:
David W. Eyre, B.M., B.Ch.
Nuffield Department of Clinical Medicine
University of Oxford
National Institute for Health Research (NIHR) Oxford Biomedical Research Centre
John Radcliffe Hospital

MedicalResearch.com: What are the main findings of this study?

Dr. Eyre: All cases of Clostridium difficile in Oxfordshire were studied over 3 years. Isolates were characterized by whole genome sequencing and the data was linked to hospital databases allowing epidemiological relationships between patients at the level of the hospital ward, hospital specialty, and post code to be identified. For comparison, similar information was also available for all other patients with and without diarrhea.  Preliminary work on the genetic diversity of Clostridium difficile within individuals and between individuals within discrete outbreaks allowed reliable interpretation of transmission events using genomic data.

This allowed a complete reconstruction of the pattern of transmission between affected cases in Oxfordshire to be made.

The findings were:
1. Unexpectedly few cases (13%) appear to be acquired from direct ward based contact with other symptomatic cases (these have previously been thought to be the main source of infections, and the focus of prevention efforts). Another 6% were associated with other hospital contact and 3% had plausible community contacts.

2. In 13% of cases potential donors were identified gnomically but no contact, within hospitals or the community, were identified. This suggests that the existence of other modes of transmission of Clostridium difficile.

3. The sources of Clostridium difficile infections were highly genetically diverse, with 45% of cases having a genetically distinct origin – suggesting a diverse reservoir of disease, not previously appreciated

4. During the 3 years of the study the rate of Clostridium difficile in Oxfordshire fell.  Any improvement in infection control techniques would be expected to reduce the incidence of cases caused by within hospital transmission. Surprisingly, similar rates of fall occurred in both in secondary cases (considered to be acquired from hospital associated symptomatic cases) and for primary cases (cases not associated with transmission from symptomatic cases).
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