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Table 1 Participant demographics

From: Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial

Demographics

 

RBX2660 FAS population1 (n = 149)

Historical control, FAS population1 (n = 104)

Mean age [range]

65.1 [19–103]

67.8 [21–97]

Participants/patients ≥ 65, n (%)

87 (58)

64 (62)

Female, n (%)

95 (64)

71 (68)

Race, white, n (%)

136 (91)

40 (38)2

Mean total CDI episodes [range]3

3.9 [2–13]

2.9 [2–5]

Mean duration all CDI episodes [range]3

23 [1–420]

29 [2–380]

Enrollment diagnostics, n (%)3

 PCR

98 (66)

82 (83)

 Enzyme Immunoassay (EIA)

35 (23)

8 (8)

 Other4

16 (11)

9 (9)

Antibiotic at enrolling CDI episode, n (%)3

 Vancomycin

120 (81)

62 (63)

 Fidaxomicin

8 (5)

5 (5)

 Metronidazole

10 (7)

6 (6)

 Other5

11 (7)

26 (26)

Received two RBX2660 doses, n (%)

143 (96)

NA

Received only one RBX2660 dose, n (%)

6 (4)

NA

  1. 1Includes all RBX2660-treated participants and the enrolled historical control participants, less six screen failures
  2. 237 of the 104 Historical Control participants had race “Not Reported”
  3. 3Five historical control participants in the FAS (3 participants in evaluable population) had incomplete CDI history records and were not able to be categorized
  4. 4Category ‘other’ for diagnostics included medical record documentation as antigen, empirically tested, loop-mediated isothermal amplification (LAMP), molecular assay, nucleic acid amplification, toxin, toxin with PCR reflex, not reported, or unknown
  5. 5Category ‘other’ for Antibiotics included medical record documentation as any combination of vancomycin, fidaxomicin, metronidazole, rifampin, and rifaximin, as well as unknown and not reported
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BMC Infectious Diseases

ISSN: 1471-2334

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