eia versus pcr for c.difficile 865
table 2. Outcomes of Patients With Hematologic Malignancy and EIA- Versus PCR-Positive Clos- tridium difficile Test Results
Outcomes
In-hospital mortalitya ICU transferb
Toxic megacolon Colectomy
C.difficile recurrence GVHD of the GI tract
Treatmentc None
Oral vancomycin
Days, median (IQR) Oral metronidazole Days, median (IQR)
Intravenous metronidazole Days, median (IQR)
Total Population, (n=182), No. (%)
33 (18) 45 (25) 2 (1) 4 (2)
21 (12) 11 (6)
4 (2) 118 (65)
15 (10–21) 107 (59)
10 (4–14) 49 (27)
6 (3–12)
versus-host disease; GI, gastrointestinal. aWithin 90 days. bWithin 30 days. cPatients may have received >1 antibiotic for treatment.
patients received treatment with oral vancomycin (59%). Two patients in the PCR(+)/EIA( −) group did not receive treat- ment; neither developed a measured adverse outcome.
discussion
We compared clinical characteristics and outcomes in patients with hematologic malignancy and an EIA- versus PCR-positive C. difficile test result after positive GDH screening. We have demonstrated that clinical characteristics and outcomes are similar in this cohort, whether results are positive by EIA or PCR. In addition, the results of our study highlight the significant morbidity and mortality of patients with C. difficile in this population, with high rates of ICU transfer and death. Particularly in a population characterized by high rates of
colonization with C. difficile,1,2 it is important to differentiate infection versus colonization. However, our results suggest that among patients with hematologic malignancy, the testing modality (ie, EIA vs PCR) cannot be used to reliably distinguish between C. difficile infection and colonization. Specifically, clinical factors typically associated with active or more severe infection9 were similar between the 2 groups. Complicating the appropriate diagnosis of CDI in this popu- lation, there was a high rate of use of laxative and stool soft- eners in the 72 hours prior to C. difficile testing in both groups. Clinical outcomes were also similar between hematologic
malignancy patients with PCR(+)/EIA(−) versus EIA(+) C. difficile test results. Morbidity and mortality were high, likely reflecting the overall complexity and severity of illness of
patients hospitalized with hematologic malignancy. However, those outcomes specific to CDI were also similar between both groups, with rates of recurrent CDI of 12% within 90 days and cases of toxic megacolon identified in the PCR(+)/EIA (−) group. Our results differ from studies of general medical patients
that have found those with toxin EIA(+) C. difficile results to have both a greater prevalence of CDI clinical characteristics and worse outcomes compared to those with PCR(+)/EIA(−) results.7,8 A prospective study without GDH screening found those with PCR(+)/EIA(−) results to have a lower prevalence of leukocytosis, fewer number of stools, and lower rates of adverse outcomes, including mortality and recurrent CDI.7 However, the 30-daymortality of 0.6%in the PCR(+)/EIA(−) group in this study compared to 15% in our study highlights the significant difference in study populations. Another recent study also demonstrated higher rates of leukocytosis, fever, and severe CDI as well as recurrent CDI with an EIA(+) result versus PCR(+)/EIA(−) result after GDH screening, but these results showed no difference in mortality between the groups.8 Notably, our study included only samples collected through routine clinical care and were tested via a multistage process, which included a C. difficile GDH screening test. While we compared EIA and PCR test results, these tests were conducted for patients who had had a positive GDH screen. In a multicenter study comparing clinical outcomes among general medical patients, GDH screening was shown to perform similarly to cytotoxigenic culture and had similar sensitivity to PCR.10 However, it is possible that our results
EIA Positive (n=81), No. (%)
18 (23) 23 (28) 0 (0) 1 (1) 7 (9) 6 (7)
0 (0) 57 (70)
15 (10–22) 43 (53)
8 (3–14) 21 (26) 6.5 (3.5–9.5)
PCR Positive (n=101), No. (%)
15 (15) 22 (22) 2 (2) 3 (3)
14 (14) 5 (5)
4 (4) 61 (60)
14 (10–21) 64 (63)
11 (6–15) 28 (28)
6 (3–15)
P Value .18
.30 .20 .42 .27 .48
.07 .16 .83 .16 .03 .79 .64
NOTE. EIA, enzyme immunoassay; PCR, polymerase chain reaction; ICU, intensive care unit; GVHD, graft-
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