Independent Predictors of Persistent Diarrhea, Recurrence, or Death in the Intent-to-Treat Analysis
| Factor . | Univariate Model . | Multivariate Model . | ||
|---|---|---|---|---|
| . | HR (95% CI) . | P Value . | HR (95% CI) . | P Value . |
| Fidaxomicin vs vancomycin | 0.54 (.42–.68) | <.0001 | 0.48 (.37–.63) | <.0001 |
| Previous anti-CDI antibioticsa in the 24 hours before randomization (yes vs no) | ||||
| Failure/death 0–12 days | 3.11 (1.95–4.97) | <.0001 | 3.11 (1.75–5.52) | .0001 |
| Recurrence/death 13–40 days | 1.24 (.95–1.62) | .12 | 1.00 (.73–1.37) | .99 |
| het P = .001 | het P = .001 | |||
| Eosinophils (/0.1 × 109/L higher) | ||||
| Failure/death 0–12 days | 0.74 (.58–.94) | .01 | 0.74 (.60–.92) | .007 |
| Recurrence/death 13–40 days | 0.99 (.90–1.09) | .78 | 0.98 (.89–1.07) | .63 |
| het P = .03 | het P = .02 | |||
| Albumin (/5 g/dL higher) | ||||
| Failure/death 0–12 days | 0.56 (.46–.68) | <.0001 | 0.64 (.51–.79) | <.0001 |
| Recurrence/death 13–40 days | 0.83 (.75–.92) | .0003 | 0.87 (.78–.98) | .02 |
| het P = .0004 | het P = .01 | |||
| Previous CDI in last 3 months (yes vs no) | ||||
| Failure/death 0–12 days | 0.84 (.44–1.58) | .58 | 0.61 (.29–1.28) | .19 |
| Recurrence/death 13–40 days | 1.52 (1.11–2.09) | .009 | 1.68 (1.19–2.37) | .003 |
| het P = .10 | het P = .02 | |||
| Creatinine clearance (/10 mL/min higher) | 0.92 (.89–.94) | <.0001 | 0.96 (.93–1.00) | .05 |
| BUN (/1 mg/dL higher) | 1.06 (1.04–1.08) | <.0001 | 1.03 (1.00–1.06) | .04 |
| Factor . | Univariate Model . | Multivariate Model . | ||
|---|---|---|---|---|
| . | HR (95% CI) . | P Value . | HR (95% CI) . | P Value . |
| Fidaxomicin vs vancomycin | 0.54 (.42–.68) | <.0001 | 0.48 (.37–.63) | <.0001 |
| Previous anti-CDI antibioticsa in the 24 hours before randomization (yes vs no) | ||||
| Failure/death 0–12 days | 3.11 (1.95–4.97) | <.0001 | 3.11 (1.75–5.52) | .0001 |
| Recurrence/death 13–40 days | 1.24 (.95–1.62) | .12 | 1.00 (.73–1.37) | .99 |
| het P = .001 | het P = .001 | |||
| Eosinophils (/0.1 × 109/L higher) | ||||
| Failure/death 0–12 days | 0.74 (.58–.94) | .01 | 0.74 (.60–.92) | .007 |
| Recurrence/death 13–40 days | 0.99 (.90–1.09) | .78 | 0.98 (.89–1.07) | .63 |
| het P = .03 | het P = .02 | |||
| Albumin (/5 g/dL higher) | ||||
| Failure/death 0–12 days | 0.56 (.46–.68) | <.0001 | 0.64 (.51–.79) | <.0001 |
| Recurrence/death 13–40 days | 0.83 (.75–.92) | .0003 | 0.87 (.78–.98) | .02 |
| het P = .0004 | het P = .01 | |||
| Previous CDI in last 3 months (yes vs no) | ||||
| Failure/death 0–12 days | 0.84 (.44–1.58) | .58 | 0.61 (.29–1.28) | .19 |
| Recurrence/death 13–40 days | 1.52 (1.11–2.09) | .009 | 1.68 (1.19–2.37) | .003 |
| het P = .10 | het P = .02 | |||
| Creatinine clearance (/10 mL/min higher) | 0.92 (.89–.94) | <.0001 | 0.96 (.93–1.00) | .05 |
| BUN (/1 mg/dL higher) | 1.06 (1.04–1.08) | <.0001 | 1.03 (1.00–1.06) | .04 |
All models stratified by study (003 or 004). Multivariate model fitted on 994 complete cases. No additional effect of severity (P = .64); inpatient versus outpatient status (P = .65); age (P = .42); sex (P = .54); race (P = .43); metronidazole failure (P = .76); or alkaline phosphatase (P = .16), creatinine (P = .78), lactate dehydrogenase (P = .12), urate (P = .15), hemoglobin (P = .80), neutrophils (P = .13), lymphocyte (P = .93), white blood cell count (P = .25), calcium (P = .56), sodium (P = .91), potassium (P = .57), chloride (P = .82), and cholesterol levels (P = .64).
Abbreviations: BUN, blood urea nitrogen; CDI, Clostridium difficile infection; CI, confidence interval; het, heterogeneity; HR, hazard ratio; ITT, intent-to-treat.
a Anti-CDI antibiotics in this study were metronidazole and vancomycin.
Independent Predictors of Persistent Diarrhea, Recurrence, or Death in the Intent-to-Treat Analysis
| Factor . | Univariate Model . | Multivariate Model . | ||
|---|---|---|---|---|
| . | HR (95% CI) . | P Value . | HR (95% CI) . | P Value . |
| Fidaxomicin vs vancomycin | 0.54 (.42–.68) | <.0001 | 0.48 (.37–.63) | <.0001 |
| Previous anti-CDI antibioticsa in the 24 hours before randomization (yes vs no) | ||||
| Failure/death 0–12 days | 3.11 (1.95–4.97) | <.0001 | 3.11 (1.75–5.52) | .0001 |
| Recurrence/death 13–40 days | 1.24 (.95–1.62) | .12 | 1.00 (.73–1.37) | .99 |
| het P = .001 | het P = .001 | |||
| Eosinophils (/0.1 × 109/L higher) | ||||
| Failure/death 0–12 days | 0.74 (.58–.94) | .01 | 0.74 (.60–.92) | .007 |
| Recurrence/death 13–40 days | 0.99 (.90–1.09) | .78 | 0.98 (.89–1.07) | .63 |
| het P = .03 | het P = .02 | |||
| Albumin (/5 g/dL higher) | ||||
| Failure/death 0–12 days | 0.56 (.46–.68) | <.0001 | 0.64 (.51–.79) | <.0001 |
| Recurrence/death 13–40 days | 0.83 (.75–.92) | .0003 | 0.87 (.78–.98) | .02 |
| het P = .0004 | het P = .01 | |||
| Previous CDI in last 3 months (yes vs no) | ||||
| Failure/death 0–12 days | 0.84 (.44–1.58) | .58 | 0.61 (.29–1.28) | .19 |
| Recurrence/death 13–40 days | 1.52 (1.11–2.09) | .009 | 1.68 (1.19–2.37) | .003 |
| het P = .10 | het P = .02 | |||
| Creatinine clearance (/10 mL/min higher) | 0.92 (.89–.94) | <.0001 | 0.96 (.93–1.00) | .05 |
| BUN (/1 mg/dL higher) | 1.06 (1.04–1.08) | <.0001 | 1.03 (1.00–1.06) | .04 |
| Factor . | Univariate Model . | Multivariate Model . | ||
|---|---|---|---|---|
| . | HR (95% CI) . | P Value . | HR (95% CI) . | P Value . |
| Fidaxomicin vs vancomycin | 0.54 (.42–.68) | <.0001 | 0.48 (.37–.63) | <.0001 |
| Previous anti-CDI antibioticsa in the 24 hours before randomization (yes vs no) | ||||
| Failure/death 0–12 days | 3.11 (1.95–4.97) | <.0001 | 3.11 (1.75–5.52) | .0001 |
| Recurrence/death 13–40 days | 1.24 (.95–1.62) | .12 | 1.00 (.73–1.37) | .99 |
| het P = .001 | het P = .001 | |||
| Eosinophils (/0.1 × 109/L higher) | ||||
| Failure/death 0–12 days | 0.74 (.58–.94) | .01 | 0.74 (.60–.92) | .007 |
| Recurrence/death 13–40 days | 0.99 (.90–1.09) | .78 | 0.98 (.89–1.07) | .63 |
| het P = .03 | het P = .02 | |||
| Albumin (/5 g/dL higher) | ||||
| Failure/death 0–12 days | 0.56 (.46–.68) | <.0001 | 0.64 (.51–.79) | <.0001 |
| Recurrence/death 13–40 days | 0.83 (.75–.92) | .0003 | 0.87 (.78–.98) | .02 |
| het P = .0004 | het P = .01 | |||
| Previous CDI in last 3 months (yes vs no) | ||||
| Failure/death 0–12 days | 0.84 (.44–1.58) | .58 | 0.61 (.29–1.28) | .19 |
| Recurrence/death 13–40 days | 1.52 (1.11–2.09) | .009 | 1.68 (1.19–2.37) | .003 |
| het P = .10 | het P = .02 | |||
| Creatinine clearance (/10 mL/min higher) | 0.92 (.89–.94) | <.0001 | 0.96 (.93–1.00) | .05 |
| BUN (/1 mg/dL higher) | 1.06 (1.04–1.08) | <.0001 | 1.03 (1.00–1.06) | .04 |
All models stratified by study (003 or 004). Multivariate model fitted on 994 complete cases. No additional effect of severity (P = .64); inpatient versus outpatient status (P = .65); age (P = .42); sex (P = .54); race (P = .43); metronidazole failure (P = .76); or alkaline phosphatase (P = .16), creatinine (P = .78), lactate dehydrogenase (P = .12), urate (P = .15), hemoglobin (P = .80), neutrophils (P = .13), lymphocyte (P = .93), white blood cell count (P = .25), calcium (P = .56), sodium (P = .91), potassium (P = .57), chloride (P = .82), and cholesterol levels (P = .64).
Abbreviations: BUN, blood urea nitrogen; CDI, Clostridium difficile infection; CI, confidence interval; het, heterogeneity; HR, hazard ratio; ITT, intent-to-treat.
a Anti-CDI antibiotics in this study were metronidazole and vancomycin.
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