Table 2

Study characteristics and clinical data reporting resolution outcomes of monoclonal antibodies and one FMT infusion from the included studies

Author, year of publicationStudy designStandard antibiotic therapyActoxumab+bezlotoxumabFMTBezlotoxumabActoxumab
Method of administration (CDI resolved/total patients)CDI resolved/total patientsCDI resolved/total patientsCDI resolved/total patientsCDI resolved/total patients
Van Nood et al, 201312 Open-label RCTVanocomycin 500 mg orally four times daily for 14 days (7/26).Vancomycin 500 mg orally four times daily for 4 days followed by FMT (13/16).
Cammarota et al, 20159 Open-label RCTVancomycin 125 mg orally four times daily for 10 days followed by 125–500 mg/day every 2–3 days for 3 weeks (5/19).Vacomycin 125 mg orallt four times daily for 3 days followed by FMT (13/20).
Hota et al, 201719 Open-label RCTVancomycin 125 mg orally four times daily for 14 days, then 125 mg orally two times daily for 7 days, then 125 mg orally daily for 7 days, then 125 mg orally every second day for 7 days, then 125 mg orally every third day for 7 days (7/12).Vancomycin 125 mg orally four times daily for 14 days followed by FMT after 48 hours (7/16).
Ng et al, 2017 (Abstract)21 Open-label RCTVancomycin 500 mg orally four times daily for 10 days (10/15).Vancomycin 500 mg orally four times daily followed by FMT (11/15).
Leav et al, 201020 Phase II double-blinded RCTStandard treatment course of vancomycin or metronidazole (14/17).Standard treatment course of vancomycin or metronidazole followed by a single dose of 10 mg/kg IV of actoxumab (24/29).
Lowy et al, 201015 Phase III double-blinded RCTStandard treatment course of vancomycin or metronidazole (74/99).Standard treatment course of vancomycin or metronidazole followed by a single dose 10 mg/kg IV of each actoxumab and bezlotoxumab (94/101).
Wilcox et al, 2017 (Modify 1)16 Phase III double-blinded RCTStandard treatment course of vancomycin, metronidazole or fidaxomicin for 10–14 days (286/395).Standard treatment course of vancomycin, metronidazole or fidaxomicin followed by a single dose 10 mg/kg IV of each actoxumab and bezlotoxumab (322/383).Standard treatment course of vancomycin, metronidazole or fidaxomicin followed by a single dose 10 mg/kg IV of bezlotoxumab (319/386).Standard treatment course of vancomycin, metronidazole or fidaxomicin followed by a single dose 10 mg/kg IV of actoxumab (172/232).
Wilcox et al 2017 (Modify 2)16 Phase III double-blinded RCTStandard treatment course of vancomycin, metronidazole or fidaxomicin for 10–14 days (281/378).Standard treatment course of vancomycin, metronidazole or fidaxomicin followed by a single dose 10 mg/kg IV of each actoxumab and bezlotoxumab (332/390).Standard treatment course of vancomycin, metronidazole or fidaxomicin followed by a single dose 10 mg/kg IV of bezlotoxumab (333/395).
  • CDI, Clostridium difficile infection; FMT, faecal microbiota transplantation; IV, intravenous; RCT, randomised controlled trial.