Ahluwalia B, Magnusson MK, Ohman L Mucosal immune system of the gastrointestinal tract: maintaining balance between the good and the bad. Scand J Gastroenterol. 2017 Nov;52(11):1185-1193. doi: 10.1080/00365521.2017.1349173. Epub 2017 Jul 12.
Johnson S, Lavergne V, Skinner AM, Gonzales-Luna AJ, Garey KW, Kelly CP, Wilcox MH Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044. doi: 10.1093/cid/ciab549.
Kyne L, Warny M, Qamar A, Kelly CP Association between antibody response to toxin A and protection against recurrent Clostridium difficile diarrhoea. Lancet. 2001 Jan 20;357(9251):189-93. doi: 10.1016/S0140-6736(00)03592-3.
Kyne L, Warny M, Qamar A, Kelly CP Asymptomatic carriage of Clostridium difficile and serum levels of IgG antibody against toxin A. N Engl J Med. 2000 Feb 10;342(6):390-7. doi: 10.1056/NEJM200002103420604.
Lawson PA, Citron DM, Tyrrell KL, Finegold SM Reclassification of Clostridium difficile as Clostridioides difficile (Hall and O'Toole 1935) Prevot 1938. Anaerobe. 2016 Aug;40:95-9. doi: 10.1016/j.anaerobe.2016.06.008. Epub 2016 Jun 28.
Meza-Torres J, Auria E, Dupuy B, Tremblay YDN Wolf in Sheep's Clothing: Clostridioides difficile Biofilm as a Reservoir for Recurrent Infections. Microorganisms. 2021 Sep 10;9(9):1922. doi: 10.3390/microorganisms9091922.
Saha S, Yadav D, Pardi R, Patel R, Khanna S, Pardi D Kinetics of polymerase chain reaction positivity in patients with Clostridioides difficile infection. Therap Adv Gastroenterol. 2021 Oct 8;14:17562848211050443. doi: 10.1177/17562848211050443. eCollection 2021.
Sethi AK, Al-Nassir WN, Nerandzic MM, Bobulsky GS, Donskey CJ Persistence of skin contamination and environmental shedding of Clostridium difficile during and after treatment of C. difficile infection. Infect Control Hosp Epidemiol. 2010 Jan;31(1):21-7. doi: 10.1086/649016.
Watt M, Dinh A, Le Monnier A, Tilleul P Cost-effectiveness analysis on the use of fidaxomicin and vancomycin to treat Clostridium difficile infection in France. J Med Econ. 2017 Jul;20(7):678-686. doi: 10.1080/13696998.2017.1302946. Epub 2017 Mar 16.
Wenisch C, Parschalk B, Hasenhundl M, Hirschl AM, Graninger W Comparison of vancomycin, teicoplanin, metronidazole, and fusidic acid for the treatment of Clostridium difficile-associated diarrhea. Clin Infect Dis. 1996 May;22(5):813-8. doi: 10.1093/clinids/22.5.813. Erratum In: Clin Infect Dis 1996 Aug;23(2):423.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.