| Variable . | BEZ(n = 38) . | SoC(n = 56) . | P value . |
|---|---|---|---|
| Zar score, median (IQR) | 0 (0–1) | 1 (0–2) | .08 |
| Complicated infection, n (%) | |||
| ICU admission | 1 (3) | 12 (21) | .01 |
| Ileus | 1 (3) | 2 (4) | .99 |
| Toxic megacolon | 0 | 0 | .99 |
| Shock | 1 (3) | 6 (11) | .20 |
| Pseudomembranous colitis | 1 (3) | 1 (2) | .99 |
| Surgical intervention for CDI episode, n (%) | 0 | 0 | .99 |
| Index CDI episode treatment, n (%)a | |||
| Vancomycin | 33 (87) | 48 (86) | .99 |
| Fidaxomicin | 13 (34) | 6 (11) | .01 |
| Metronidazole | 4 (11) | 26 (46) | < .01 |
| Combination (> 1 treatments above) | 5 (13) | 22 (39) | .01 |
| Duration of CDI treatment, median (IQR) | 27 (15–57) | 17 (14–31) | .03 |
| Extended CDI treatment (> 14 days), n (%) | 28 (74) | 29 (52) | .05 |
| Tapering treatment regimen, n (%) | 22 (58) | 13 (23) | < .01 |
| Prophylaxis, n (%) | 8 (21) | 4 (7) | .06 |
| Adjunctive CDI therapies, n (%) | |||
| Probiotics | 2 (5) | 2 (4) | .99 |
| Rifaximin | 0 | 0 | .99 |
| Toxin-binding agent | 0 | 0 | .99 |
| Intravenous Immunoglobulin | 0 | 0 | .99 |
| Fecal Microbiota Transplant | 4 (11) | 5 (9) | .99 |
| Risk factors for recurrence, n (%) | |||
| Immunocompromised | 38 (100) | 56 (100) | .99 |
| Age ≥ 65 years | 10 (26) | 12 (21) | .58 |
| Concomitant antibiotic use after CDI episode | 27 (71) | 36 (64) | .66 |
| Proton pump inhibitor use | 15 (40) | 34 (61) | .04 |
| Proteinuria | 17 (45) | 31 (55) | .31 |
| Severe CDI (Zar > 2) | 5 (13) | 18 (32) | .04 |
| Prior CDI | 30 (79) | 29 (52) | .01 |
| Number of risk factors for recurrence, median (IQR) | 4 (3–5) | 4 (3–4) | .36 |
| Variable . | BEZ(n = 38) . | SoC(n = 56) . | P value . |
|---|---|---|---|
| Zar score, median (IQR) | 0 (0–1) | 1 (0–2) | .08 |
| Complicated infection, n (%) | |||
| ICU admission | 1 (3) | 12 (21) | .01 |
| Ileus | 1 (3) | 2 (4) | .99 |
| Toxic megacolon | 0 | 0 | .99 |
| Shock | 1 (3) | 6 (11) | .20 |
| Pseudomembranous colitis | 1 (3) | 1 (2) | .99 |
| Surgical intervention for CDI episode, n (%) | 0 | 0 | .99 |
| Index CDI episode treatment, n (%)a | |||
| Vancomycin | 33 (87) | 48 (86) | .99 |
| Fidaxomicin | 13 (34) | 6 (11) | .01 |
| Metronidazole | 4 (11) | 26 (46) | < .01 |
| Combination (> 1 treatments above) | 5 (13) | 22 (39) | .01 |
| Duration of CDI treatment, median (IQR) | 27 (15–57) | 17 (14–31) | .03 |
| Extended CDI treatment (> 14 days), n (%) | 28 (74) | 29 (52) | .05 |
| Tapering treatment regimen, n (%) | 22 (58) | 13 (23) | < .01 |
| Prophylaxis, n (%) | 8 (21) | 4 (7) | .06 |
| Adjunctive CDI therapies, n (%) | |||
| Probiotics | 2 (5) | 2 (4) | .99 |
| Rifaximin | 0 | 0 | .99 |
| Toxin-binding agent | 0 | 0 | .99 |
| Intravenous Immunoglobulin | 0 | 0 | .99 |
| Fecal Microbiota Transplant | 4 (11) | 5 (9) | .99 |
| Risk factors for recurrence, n (%) | |||
| Immunocompromised | 38 (100) | 56 (100) | .99 |
| Age ≥ 65 years | 10 (26) | 12 (21) | .58 |
| Concomitant antibiotic use after CDI episode | 27 (71) | 36 (64) | .66 |
| Proton pump inhibitor use | 15 (40) | 34 (61) | .04 |
| Proteinuria | 17 (45) | 31 (55) | .31 |
| Severe CDI (Zar > 2) | 5 (13) | 18 (32) | .04 |
| Prior CDI | 30 (79) | 29 (52) | .01 |
| Number of risk factors for recurrence, median (IQR) | 4 (3–5) | 4 (3–4) | .36 |
Data are presented as No. (%) unless otherwise indicated. IQR represents values in the 25th to 75th percentile.
Abbreviations: CDI, Clostridioides difficile Infection; BEZ, bezlotoxumab; IQR, interquartile range; SoC, standard of care.
aPatients may have received more than one agent, either sequentially or concomitantly (combination).
| Variable . | BEZ(n = 38) . | SoC(n = 56) . | P value . |
|---|---|---|---|
| Zar score, median (IQR) | 0 (0–1) | 1 (0–2) | .08 |
| Complicated infection, n (%) | |||
| ICU admission | 1 (3) | 12 (21) | .01 |
| Ileus | 1 (3) | 2 (4) | .99 |
| Toxic megacolon | 0 | 0 | .99 |
| Shock | 1 (3) | 6 (11) | .20 |
| Pseudomembranous colitis | 1 (3) | 1 (2) | .99 |
| Surgical intervention for CDI episode, n (%) | 0 | 0 | .99 |
| Index CDI episode treatment, n (%)a | |||
| Vancomycin | 33 (87) | 48 (86) | .99 |
| Fidaxomicin | 13 (34) | 6 (11) | .01 |
| Metronidazole | 4 (11) | 26 (46) | < .01 |
| Combination (> 1 treatments above) | 5 (13) | 22 (39) | .01 |
| Duration of CDI treatment, median (IQR) | 27 (15–57) | 17 (14–31) | .03 |
| Extended CDI treatment (> 14 days), n (%) | 28 (74) | 29 (52) | .05 |
| Tapering treatment regimen, n (%) | 22 (58) | 13 (23) | < .01 |
| Prophylaxis, n (%) | 8 (21) | 4 (7) | .06 |
| Adjunctive CDI therapies, n (%) | |||
| Probiotics | 2 (5) | 2 (4) | .99 |
| Rifaximin | 0 | 0 | .99 |
| Toxin-binding agent | 0 | 0 | .99 |
| Intravenous Immunoglobulin | 0 | 0 | .99 |
| Fecal Microbiota Transplant | 4 (11) | 5 (9) | .99 |
| Risk factors for recurrence, n (%) | |||
| Immunocompromised | 38 (100) | 56 (100) | .99 |
| Age ≥ 65 years | 10 (26) | 12 (21) | .58 |
| Concomitant antibiotic use after CDI episode | 27 (71) | 36 (64) | .66 |
| Proton pump inhibitor use | 15 (40) | 34 (61) | .04 |
| Proteinuria | 17 (45) | 31 (55) | .31 |
| Severe CDI (Zar > 2) | 5 (13) | 18 (32) | .04 |
| Prior CDI | 30 (79) | 29 (52) | .01 |
| Number of risk factors for recurrence, median (IQR) | 4 (3–5) | 4 (3–4) | .36 |
| Variable . | BEZ(n = 38) . | SoC(n = 56) . | P value . |
|---|---|---|---|
| Zar score, median (IQR) | 0 (0–1) | 1 (0–2) | .08 |
| Complicated infection, n (%) | |||
| ICU admission | 1 (3) | 12 (21) | .01 |
| Ileus | 1 (3) | 2 (4) | .99 |
| Toxic megacolon | 0 | 0 | .99 |
| Shock | 1 (3) | 6 (11) | .20 |
| Pseudomembranous colitis | 1 (3) | 1 (2) | .99 |
| Surgical intervention for CDI episode, n (%) | 0 | 0 | .99 |
| Index CDI episode treatment, n (%)a | |||
| Vancomycin | 33 (87) | 48 (86) | .99 |
| Fidaxomicin | 13 (34) | 6 (11) | .01 |
| Metronidazole | 4 (11) | 26 (46) | < .01 |
| Combination (> 1 treatments above) | 5 (13) | 22 (39) | .01 |
| Duration of CDI treatment, median (IQR) | 27 (15–57) | 17 (14–31) | .03 |
| Extended CDI treatment (> 14 days), n (%) | 28 (74) | 29 (52) | .05 |
| Tapering treatment regimen, n (%) | 22 (58) | 13 (23) | < .01 |
| Prophylaxis, n (%) | 8 (21) | 4 (7) | .06 |
| Adjunctive CDI therapies, n (%) | |||
| Probiotics | 2 (5) | 2 (4) | .99 |
| Rifaximin | 0 | 0 | .99 |
| Toxin-binding agent | 0 | 0 | .99 |
| Intravenous Immunoglobulin | 0 | 0 | .99 |
| Fecal Microbiota Transplant | 4 (11) | 5 (9) | .99 |
| Risk factors for recurrence, n (%) | |||
| Immunocompromised | 38 (100) | 56 (100) | .99 |
| Age ≥ 65 years | 10 (26) | 12 (21) | .58 |
| Concomitant antibiotic use after CDI episode | 27 (71) | 36 (64) | .66 |
| Proton pump inhibitor use | 15 (40) | 34 (61) | .04 |
| Proteinuria | 17 (45) | 31 (55) | .31 |
| Severe CDI (Zar > 2) | 5 (13) | 18 (32) | .04 |
| Prior CDI | 30 (79) | 29 (52) | .01 |
| Number of risk factors for recurrence, median (IQR) | 4 (3–5) | 4 (3–4) | .36 |
Data are presented as No. (%) unless otherwise indicated. IQR represents values in the 25th to 75th percentile.
Abbreviations: CDI, Clostridioides difficile Infection; BEZ, bezlotoxumab; IQR, interquartile range; SoC, standard of care.
aPatients may have received more than one agent, either sequentially or concomitantly (combination).
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