A pilot study to assess bacterial and toxin reduction in patients with Clostridium difficile infection given fidaxomicin or vancomycin

Thabit, Abrar K.; Alam, M. Jahangir; Khaleduzzaman, Mohammed; Garey, Kevin W.; Nicolau, David P.

doi:10.1186/s12941-016-0140-6

Annals of Clinical Microbiology and Antimicrobials

Table 3 C. difficile toxin A and B concentrations based on clinical outcomes

From: A pilot study to assess bacterial and toxin reduction in patients with Clostridium difficile infection given fidaxomicin or vancomycin

Period	Outcome measure	Therapy	Baseline	Mid-point	End-of-therapy	Follow-up
End of therapy	Cured	Fidaxomicin	A: 40.2 ± 39.8 (50 %); n = 3/6 B: 48.8 ± 28.8 (100 %); 6/6	A: 0.7 ± 1 (0.2 %); n = 1/6 B: 5.2 ± 10.8 (0.2 %); n = 1/6	A: 0.3 ± 0 (0 %); 0/6 B: 0.3 ± 0 (0 %); 0/6	N/A
	Cured	Vancomycin	A: 28.2 ± 36.6 (100 %); n = 3/3 B: 26.9 ± 37.6 (33.3 %); n = 1/3	A: 0.3 ± 0 (0 %); n = 0/3 B: 0.8 ± 0.7 (33.3 %); n = 1/3	A: 19.1 ± 26.6 (33.3 %); n = 1/3 B: 26.9 ± 37.6 (33.3 %); n = 1/3	N/A
	Failed	Fidaxomicin^a	N/A	N/A	N/A	N/A
	Failed	Vancomycin	A: 25.5 ± 21.5 (100 %); n = 2/2 B: 40.2 ± 56.3 (50 %); n = 1/2	A: 0.3 ± 0 (0 %); n = 0/2 B: 6.4 ± 3.3 (100 %); n = 2/2	N/A	N/A
Follow-up	Sustained cure	Fidaxomicin	A: 20.2 ± 34.5 (25 %); n = 1/4 B: 33.3 ± 22.9 (100 %); n = 4/4	A: 0.3 ± 0 (0 %); n = 0/4 B: 0.3 ± 0 (0 %); n = 0/4	A: 0.3 ± 0 (0 %); n = 0/4 B: 0.3 ± 0 (0 %); n = 0/4	A: 0.3 ± 0 (0 %); n = 0/4 B: 0.3 ± 0 (0 %); n = 0/4
	Sustained cure	Vancomycin^b	A: 2.2 (100 %); n = 1/1 B: 0.3 (0 %); n = 0/1	A: 0.3 (0 %); n = 0/1 B: 0.3 (0 %); n = 0/1	A: 0.3 (0 %); n = 0/1 B: 0.3 (0 %); n = 0/1	A: 0.3 (0 %); n = 0/1 B: 0.3 (0 %); n = 0/1
	CDI recurrence	Fidaxomicin	A: 80 ± 0 (100 %); n = 2/2 B: 80 ± 0 (100 %); n = 2/2	A: 1.6 ± 1.3 (50 %); n = 1/2 B: 15 ± 14.5 (50 %); n = 1/2	A: 0.3 ± 0 (0 %); n = 0/2 B: 0.3 ± 0 (0 %); n = 0/2	A: 0.3 ± 0 (0 %); n = 0/2 B: 14.2 ± 8.5 (100 %); n = 2/2
	CDI recurrence	Vancomycin^b	A: 2.5 (100 %); n = 1/1 B: 0.3 (0 %); n = 0/1	A: 0.3 (0 %); n = 0/1 B: 1.7 (100 %); n = 1/1	A: 56.7 (100 %); n = 1/1 B: 80 (100 %); n = 1/1	A: 70.8 (100 %); n = 1/1 B: 50.4 (100 %); n = 1/1

Values represent mean ± standard deviation (proportion of patients with a detectable toxin concentration)
The lower and upper limits of detection were 0.3 and 80 ng/mL, respectively, for both toxin A and B
CDI Clostridium difficile infection, N/A not applicable
^aNone of fidaxomicin patients failed therapy at the end of the 10-day treatment course
^bIn the vancomycin group, one patient experienced sustained cure while one developed CDI recurrence, thus standard deviation is not reported

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ISSN: 1476-0711

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