Table 3.
Summary of non-FDA approved or real-world experience with Dalbavancin studies in adult patients
| Citation (year) | Study design | Infection(s) | Study population | Dose and duration | Treatment response | Adverse drug events |
|---|---|---|---|---|---|---|
| Raad et al. (2005) [12] | Phase 2 randomized, controlled, open label trial, 13 sites |
Catheter-related bloodstream infections 23% MSSA 20% MRSA 50% CoNS |
United States Initial treatment Excluded renal and liver dysfunction, immune suppression, complicated infections N = 26 (23 in mITT) |
1000 mg, 1 week later 500 mg | EOT mITT 20/23 (87%) vs. vancomycin 14/28 (50%) | Hypotension (21%), constipation (18%), diarrhea (21%), anemia (18%) |
| Rappo et al. (2018) [13] | Phase 2 randomized, open-label, comparator-controlled, parallel-group |
Osteomyelitis (first episode) 54% MSSA 6% MRSA 20% CoNS |
Ukraine Initial treatment DM (14% in Dalbavancin group vs. 50% SOC) No SUD N = 70 (67 included due to follow-up) |
1500 mg 2 doses, 1 week apart |
Clinical cure at day 42: 65/67 (97%) vs. 7/8 (88%) SOC | None related to dalbavancin, but 14.3% treatment emergent AE, anemia and bleeding |
| Tobudic et al. (2018) [15] | Case series |
Infective endocarditis: 16 native valve, 6 prosthetic valve, 5 cardiac device 29% S. aureus 26% Streptococcus 13% Enterococcus |
Austria Sequential treatment N = 31 (27 included, due to missing data) |
1000 mg loading, 500 mg maintenance weekly, Median duration 6 weeks (range 1–30 weeks) | Clinical and microbiologic success 6 months after completed therapy 25/27 (93%) |
1 patient with nausea 1 patient with 2.5-fold increase in creatinine |
| Bouza et al. (2019) [16] | Case series, 29 sites |
Mixed infections: PJI, ABSSSI, OM, IE most common 35% CoNS 23% MRSA 18% MSSA 18% Enterococcus |
Spain Both initial and sequential treatment immune suppressed (28%) DM 23% N = 69 |
1500 mg weekly × 2 or 1000 mg × 1 followed by 500 every week, median duration 3 weeks (range 1–24) |
Clinical success at 30 days after completion in 58/69 (84%) (92% for OM, 86% for IE and 75% CRBSI) No issues with follow-up or missing data reported |
2 patients with renal dysfunction; also rash, nausea |
| Wunsch et al. (2019) [17] | Case series, 3 sites |
Mixed infections: ABSSSI, PJI, OM, IE, CRBSI 33% CoNS 16% MSSA 8% MRSA |
Austria Both initial and sequential treatment N = 101 (7 excluded for follow-up or serious ADE) |
Variable, 1500 mg weekly or 1000 mg X1, followed by 500 mg every week, median 3 doses (range 1–32), regimens varied |
Clinical success at 90 days after completion was 84/94 (89%) (92% for IE, 85% for OM, 93% for PJI) |
3%, anaphylaxis, fatigue, vertigo |
| Brysom-Cohn et al. (2019) [18] | Case series |
S. aureus-related infections: IE, OM, bacteremia, septic arthritis 88% MRSA |
Unites States Both initial and sequential treatment PWID N = 32 (17 completed course, 22 where ultimately evaluable) |
Variable, 1500 mg or 1000 mg × 1, followed by 500 mg or 1000 mg every week, median duration 1 dose (range 1–5) |
Clinical success at 1 year follow-up 18/22 (81%) |
None reported |
| Morata et al. (2019) [19] | Case series, 30 sites |
Bone and joint infections 22% S. aureus 47% CoNS |
Spain Both initial and sequential treatment DM (16%) N = 64 (1 lost to follow-up) |
Variable 1500 mg or 1000 mg × 1, followed by 500 mg or 1000 mg every week, median of 5 doses (IQR 3–7) | Clinical success during or after treatment 45/63 (71%), highest when implant removed (76% vs. 65%) | 3 GI distress, 1 rash, 1 increase in creatinine, none stopped because of AE |
| Almangour et al. (2019) [20] | Case series, 3 sites |
Osteomyelitis MRSA 48% MSSA 39% |
Unites States Both initial and sequential treatment DM (32%) IVDU (32%) N = 34 (3 lost to follow-up) |
Variable 1500 mg or 1000 mg × 1 followed by 500 mg or 1000 mg every week, median 3 (range 1–14) | Clinical success at EOT was 28/31 (90%) | None reported |
EOT end of treatment, SOC standard of care, ADE adverse drug event, AE adverse event, MSSA methicillin susceptible S. aureus, MRSA methicillin-resistant S. aureus, CoNS coagulase negative S. aureus, mITT modified intention to treat, DM diabetes mellitus, SUD substance use disorder, AE adverse event, PJI prosthetic joint infection, ABSSSI acute bacterial skin and skin structure infection, OM osteomyelitis, IE infective endocarditis, CRBSI catheter-related bloodstream infection, IVDU intravenous drug use