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European Biopharmaceutical Review

Treatment Options for Clostridioides Difficile

While COVID-19 is dominating the infectious disease space, many do not realise that patients with COVID-19 infection are frequently co-infected with bacterial infections (e.g., sepsis, bacterial pneumonia, etc.) that can lead to hospitalisation and the need for antibiotic therapy. An immediate by-product of the COVID-19 pandemic has been an increase in antimicrobialresistant infections, including Clostridioides difficile. C diff is a pervasive public health concern in elderly, hospitalised patients, and residents of long-term care facilities (LTCFs) who have recently undergone antibiotic therapy.

Originally discovered in 1935, C diff was identified as the organism responsible for the majority of cases of antibioticassociated diarrhoea and life-threatening colitis (1). Today, with the development, widespread use, and poor prescribing practices of antibiotics over time, C diff infection rates have increased exponentially. C diff is now listed by the Centers for Disease Control and Prevention as being among the top five urgent antibiotic resistance threats in the US, with recent data reporting 223,900 infections and 12,800 deaths due to C diff in 2017 alone (2-3). Since the onset of the COVID-19 pandemic in 2019, it is estimated that approximately 72% of COVID-19 patients were treated with broad-spectrum antibiotics, mostly respiratory quinolones, to prevent bacterial co-infections. As such, the number of C diff infections, particularly recurrences, is expected to increase over time. Complicating factors include the overlap of gastrointestinal (GI) associated COVID-19 symptoms with those of C diff disease in co-infected patients, which can present diagnostic challenges resulting in under or misdiagnosis, leading to delayed initiation of appropriate treatment (4).

Common symptoms of C diff infection include profuse diarrhoea, abdominal pain, and fever, which can culminate and result in a life-threatening illness called toxic megacolon. Even mild-to-moderate symptoms can be debilitating and disruptive to daily life, as patients oftentimes report 10-20 bowel-only movements per day. Dehydration is another common but under-recognised sequela, as the patient is not able to consume enough fluids and electrolytes to offset the losses that occur due to these symptoms.

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Shelley McLendon, Vice President, Project Management, has more than 23 years of clinical research experience, 17 of which are tenured at ICON. Shelley provides executive leadership and oversight for ICONís clinical and project management teams in the implementation and execution of vaccine and infectious disease clinical development programmes. She also consults with small to mid-size biotechnology clients and large pharmaceutical companies providing strategic operational guidance and driving partnership development. Shelley is a key leader of ICONís COVID-19 taskforce: a cross-functional team of ICON executive leaders whose mission is to make a difference by advancing research in the fight against COVID-19.

Kelley Struble, DO, Medical Director, Medical Affairs, is an Infectious Disease Physician with more than 10 years in private practice and two years of clinical research experience. Kelley also has six years of experience in telemedicine and is currently practicing. She is a core member of ICONís vaccines and infectious disease operations team, providing medical expertise and guidance for commercial and government vaccine and infectious disease clinical development programmes, including protocol and clinical plan development. She also serves as lead medical monitor on ICON studies including a global COVID-19 vaccine mega trial recruiting 30,000 healthy participants. Kelley is a key member of ICONís COVID-19 Rapid Response Team and is on the frontline ensuring the safety of trial participants and advancing research in the fight against COVID-19.
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Shelley McLendon
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Kelley Struble
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