sons of DALVANCE to vancomycin/linezolid based on clinical success rates at these visits cannot be utilized to establish non-inferiority.
Table 8. Clinical Success Rates in ABSSSI Trials at Follow-Up (Day 26 to 30) DALVANCE
n/N (%) Vancomycin/Linezolid
n/N (%) Difference
(95%CI)3
Trial 1
ITT
241/288 (83.7%)
251/285 (88.1%)
-4.4% (-10.1, 1.4)
CE
212/226 (93.8%)
220/229 (96.1%)
-2.3% (-6.6, 2.0)
Trial 2
ITT
327/371 (88.1%)
311/368 (84.5%)
3.6% (-1.3, 8.7)
CE
283/294 (96.3%)
257/272 (94.5%)
1.8% (-1.8, 5.6)
1 There were 7 patients (as described in Table 6) who did not receive treatment and were counted as failures in the ITT analysis.
2 Patients who died, used non-study antibacterial therapy, or had an unplanned surgical intervention 72 hours after the start of therapy were classified as Clinical Failures.
3 The 95% CI is computed using the Miettinen and Nurminen approach, stratified by baseline fever status.
Table 9 shows outcomes in patients with an identified baseline pathogen, using pooled data from Trials 1 and 2 in the microbiological ITT (microITT) population. The outcomes shown in the table are clinical response rates at 48 to 72 hours and clinical success rates at follow-up (Day 26 to 30), as defined above.
Table 9. Outcomes by Baseline Pathogen (MicroITT) Early Clinical Response at 48-72 hours
Early Responder2 ≥ 20% reduction in lesion size Clinical Success at Day 26 to 30
Pathogen
DALVANCE
n/N (%)
Comparator
n/N (%)
DALVANCE
n/N (%)
Comparator
n/N (%)
DALVANCE
n/N (%)
Comparator
n/N (%)
Staphylococcus aureus
Methicillin-susceptible
Methicillin-resistant
206/257 (80.2)
134/167 (80.2)
72/90 (80.0)
219/256 (85.5)
163/189 (86.2)
56/67 (83.6)
239/257 (93.0)
156/167 (93.4)
83/90 (92.2)
232/256 (90.6)
173/189 (91.5)
59/67 (88.1)
217/257 (84.4)
142/167 (85.0)
75/90 (83.3)
229/256 (89.5)
171/189 (90.5)
57/67 (85.1)
Streptococcus agalactiae
6/12 (50.0)
11/14 (78.6)
10/12 (83.3)
10/14 (71.4)
10/12 (83.3)
11/14 (78.6)
Streptococcus pyogenes
28/37 (75.7)
24/36 (66.7)
32/37 (86.5)
27/36 (75.0)
33/37 (89.2)
32/36 (88.9)
Streptococcus anginosus group
18/22 (81.8)
23/ 25 (92.0)
21/22 (95.5)
25/25 (100.0)
21/22 (95.5)
23/25 (92.0)
1 There were 2 patients in the dalb |
