Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

Summary

Patients diagnosed to have mild-moderate CDI will be randomized to receive IM-01 egg-derived anti-C. difficile polyclonal antibodies in increasing dosages, twice daily, for a total of 10 - 14 days. Resolution of diarrhea and other symptoms and fecal test parameters will be used to assess clinical effectiveness of Immunotherapy with IM-01 antibodies. Patients will be followed for recurrence of CDI. Subjects who are assessed as non-respondents to IM-01 will be reassessed and treated with standard of care CDI antibiotics for 10 -14 days.

Timeline

Start

2019-10-04

Primary completion

2023-12-30

Completion

2024-03-30

Publications

• Results LITERATURE REFERENCES 1. Halsey J. Am. J. Health-Syst Pharm 65: 705-715, 2008. 2. Lessa, F.C et al. N.Eng.J.Med.372: 825-834, 2015. 3. Kee, V. R. Amer. J. Geriatric Pharmacotherapy. 10: 14-24, 2012 4. Centers for Disease Control and Prevention. Vital signs: Making healthcare safer. Stopping C. difficile infections. http:/www.cdc.gov/vitalsigns/Hai/StoppingC.difficile/. March, 2012 5. Comparison of the burdens of hospital-onset, healthcare facility-associated Clostridium difficile Infection and of healthcare-associated infection due to methicillin-resistant Staphylococcus aureus in community hospitals. Miller B.A. et al. Infect Control Hosp Epidemiol. 32:387-390, 2011. 6. (APIC) National Prevalence study for Clostridium difficile in US Healthcare Facilities. November 11, 2008. 7. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI). Bauer , M.P.; Kuijper, E.J. van Dissel, I.T;. Clin. Microbiol. Infect. 2009, 15: 1067-79. 8. Society for Healthcare Epidemiology of America; Infectious Disease Society of America Clinical Practice guidelines for Clostridium difficile infection in adults: 2010 updates by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Disease Society of America (IDSA). Cohen S.F.; Gerding, D.N.; Johnson, S; et al. Infect. Control Hosp. Epidemiol. 2010, 31: 431-55. 9. Treatment of First recurrence of Clostridium difficile Infection Fidaxomicin Versus Vancomycin. Cornely, O.A; Miller, M.A; Louie, T.J. et al. Clin. Infect. Dis. 2012, 55 (Suppl 2) S154-61. 10. Fidaxomycin versus Vancomycin for C. difficile infections. Louie, T.J; Miller, M.A.; Mullane. D.O et al. New Eng. J. Med. 2011, 364: 422031. 11. Consequence of Clostridium difficile infection: Understanding of healthcare burden. Bouza E. Clin. Microbiol. Infect. 18 (suppl 6) 5-12, Dec 2012. 12. Emergence and global spread of epidemic healthcare-associated Clostridium difficile. He M, Miyajima F, Roberts P et al. Nat. Genet. 45: 109-113, 2012. 13. PCR ribotyping and antimicrobial susceptibility testing of isolates of Clostridium difficile cultured from toxin-positive diarrheal stools of patients receiving medical care in Canadian hospitals: the Canadian Clostridium difficile Surveillance Study (CAN-DIFF) 2013-2015. Karlowsky J. A et al. Diag. Microbiol and Infect Dis. Vol 91. Pages 105-111, 2018 . 14. Antibodies for Treatment of Clostridium difficile Infections. Humphreys, D.P. and Wilcox, M.H. Clinical and Vaccine Immunology 21: 913-923, 2014. 15. Association between antibody response to toxin A and protection against recurrent C. difficile diarrhea. Kyne l et al. Lancet 357: 189-193, 2001. 16. IgG Antibody Response to Toxin A and Toxin B in patients with Clostridium difficile Infection. Wullt M et al. Clin. Vaccine Immunol. 19; 1552-54, 2012. Protocol CP-IM-01-2017A 10 July 2018 (Version 5) ________________________________________________________________________________________________________

Drugs

Indications