Table 4:
Clinical Effectiveness
Outcomes | Solithromycin | Comparator | ||
---|---|---|---|---|
All ages | n/N (%) | 95% CI | n/N (%) | 95% CI |
Clinical improvement1 | 40/62 (64.5) | 51%, 76% | 17/21 (81.0) | 58%, 95% |
Early clinical response2 | 34/51 (66.7) | 52%, 79% | 7/15 (46.7) | 21%, 73% |
Clinical cure3 | 36/60 (60.0) | 47%, 72% | 13/19 (68.4) | 43%, 87% |
2 months – 5 years | ||||
Clinical improvement1 | 5/10 (50.0) | 19%, 81% | 2/3 (66.7) | 9%, 99% |
Early clinical response2 | 4/9 (44.4) | 14%, 79% | 1/5 (20.0) | 1%, 72% |
Clinical cure3 | 4/9 (44.4) | 14%, 79% | 3/4 (75.0) | 19%, 99% |
6-17 years | ||||
Clinical improvement1 | 35/52 (67.3) | 53%, 80% | 15/18 (83.3) | 59%, 96% |
Early clinical response2 | 30/42 (71.4) | 55%, 84% | 6/10 (60.0) | 26%, 88% |
Clinical cure3 | 32/51 (62.7) | 48%, 76% | 10/15 (66.7) | 38%, 88% |
assessed on last day of treatment (+48 hours) and defined as an improvement in at least one CABP presenting sign or symptom with no deterioration in any sign or symptom of CABP, no development of new sign or symptom of CABP, and no requirement for additional or alternative antimicrobial therapy
assessed on days 2-4 and defined similarly to clinical improvement
assessed on day 16 post-randomization (± 4 days) and defined resolution of all presenting CABP signs and symptoms and no requirement for an additional antibiotic, CI – confidence intervals