Table 1.
Summary of the Evidence Comparing the off-Label Use of Dalbavancin for the Treatment of Gram-Positive Infections with Standard of Care
| Author, Year and Reference | Study Design | No. of Patients | Clinical Features | Dalbavancin | Comparator | Isolates | Duration of Follow-Up | Outcome | Relapse Rate – Resistance Development | Safety (Overall Proportion of AEs) |
|---|---|---|---|---|---|---|---|---|---|---|
| Rappo et al., 201928 | Randomized controlled trial, open-label | 80 | Concomitant bacteraemia: 5.7% vs 10.0% |
70 Osteomyelitis 1500 mg day 1 + 1500 mg day 8 |
10 Standard of care Vancomycin followed by Linezolid or Levofloxacin or Cefotaxime/Ceftriaxone |
38 MSSA 14 CoNS 9 Anaerobes 7 E. faecalis 4 MRSA 3 Streptococcus spp. 1 E. faecium 5 Others |
42 days 6 months 1 years |
Clinical cure at 42-day: 97% vs 88% Clinical cure at 6-months: 95% vs 88% Clinical cure at 1-year: 94% vs 88% |
Requirement for additional ABT in dalbavancin group in 1.5% of patients | 1.4% vs 0.0% |
| Raad et al., 200529 | Randomized controlled trial, multicentric, Phase 2 | 67 | ICU admission: 24.0% |
33 CR-BSI 1000 mg day 1 + 500 mg day 8 |
34 Vancomycin 1 g q12h for 14 days |
13 CoNS 6 MSSA 5 MRSA 2 E. faecalis |
14 days | Overall success rate: 87.0% (95% CI 73.2–100%) vs 50.0% (95% CI 31.5–68.5%) |
None | No difference between arms No serious AE in dalbavancin group |
| Veve et al., 202030 | Retrospective case-control study | 215 | ICU admission: 21.9% Vasopressor use: 8.4% |
70 49 osteoarticular infections 12 IE 9 other BSI 46% overall BSI 100% prior ABT |
145 (78 vancomycin 67 daptomycin) 53 osteoarticular infections 47 other BSI 45 IE 86% overall BSI |
173 MRSA 16 MSSA 8 CoNS 7 Streptococcus spp 6 E. faecalis |
90 days | 90-day IRR: 17% vs 28% (p = 0.12) 90-day mortality rate: 3% vs 3% (p = 1.00) Dalbavancin use was independently associated with lower IRR (OR: 0.10; 95% CI: 0.04–0.31) |
Relapse with dalbavancin: 6% |
3% vs 14% (p=0.013) |
Abbreviations: ABT, antibiotic therapy; AEs, adverse events; CI, confidence interval; CoNS, coagulase-negative Staphylococcus; CR-BSI, catheter-related bloodstream infections; ICU, intensive care unit; IE, infective endocarditis; IRR, infection-related readmission; MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus; OR, odds ratio.