Table 4.
Summary of the Evidence Investigating the off-Label Use of Dalbavancin for the Treatment of Bone and Joint Infections
| Author, Year and Reference | Study Design | No. of Patients | Clinical Features | Prior Antibiotic and Duration | Antibiotic and Dosing | Isolates | Duration of Follow-Up | Outcome | Relapse Rate – Resistance Development | Safety (Overall Proportion of AEs) |
|---|---|---|---|---|---|---|---|---|---|---|
| Morata et al., 201954 | Retrospective cohort study, multicentric | 64 | 45 Implant-associated infection 19 Bone or joint infection |
100.0% | Dalbavancin LD 1000 mg (N= 50) – 1500 mg (N= 12) – 500 mg (N= 1) – 750 mg (N= 1) Single dose (N= 9) Followed by 500 mg/week (N= 54; median duration 5 weeks) Followed by 1500 mg biweekly (N= 1; four total doses) |
30 S. epidermidis 14 S. aureus 5 E. faecalis 4 E. faecium 3 C. striatum 3 Streptococcus spp. 2 S. lugdunensis 1 S. capitis 1 S. pneumoniae |
Latest medical visit | Clinical success or improvement: 97.7% (implant-associated infections) Clinical success or improvement: 89.5% (bone or joint infections) Mortality rate: 6.3% |
Relapse: 3.1% |
NA |
| Wunsch et al., 201933 | Retrospective cohort study, multicentric | 62 (101 overall patients included in the study) |
32 prosthetic joint infection 30 osteomyelitis OPAT 49% |
100.0% | Dalbavancin 1500 mg single dose or 1500 mg + 1500 mg or 1000 mg + 500 mg |
28 CoNS 14 MSSA 8 MRSA 7 Enterococcus spp. 5 Streptococcus spp. 4 P. acnes 21 Others |
90 days after the last dose of dalbavancin | Overall clinical success: 89% (93.6% bone and joint infections) 90-day mortality rate: 5% (3.2% bone and joint infections) Overall clinical failure: 5% (3.2% bone and joint infections) |
NA | 3% (overall) |
| Bai et al., 202038 | Retrospective cohort study, multicentric | 50 (82 overall patients included in the study) |
25 Osteomyelitis 17 Prosthetic joint infections 4 Spondylodiscitis 4 Septic arthritis OPAT 57.8% |
82.5% | Dalbavancin 1000 mg (LD) + 500 mg or 1500 mg single dose |
28 CoNS 24 MRSA 14 MSSA 6 E. faecalis 5 E. faecium 5 Others |
30–180 days | Clinical success at end of study: 89.7% (osteomyelitis – spondylodiscitis) 76.5% (prosthetic joint infections) 75.0% (septic arthritis) |
Relapse: 17.8% (overall in the study) |
7.0% |
| Dinh et al., 201934 | Retrospective cohort study, multicentric | 48 (75 overall patients included in the study |
OPAT 49.3% | 98.7% | Dalbavancin 1000–1500 mg single-dose or 1000 mg + 500 mg or 1000 mg + 1000 mg or 1500 mg/weekly up to > 4 doses |
32 CoNS 23 MSSA 14 MRSA 5 E. faecalis 5 Corynebacterium spp. Range median MIC 0.032–0.064 mg/L |
NA | Clinical cure: 76.1% (bone and joint infections) |
Relapse: 4% (overall) |
6.7% (not serious) |
| Tobudic et al., 201953 | Retrospective cohort study | 46 (72 overall patients included in the study) |
20 Osteomyelitis 14 Spondylodiscitis 8 Prosthetic joint infections 4 Acute septic arthritis |
81% | Dalbavancin 1000 mg LD + 500 mg weekly 1500 mg LD + 1000 mg biweekly 1500 mg day 1 + 1500 mg day 8 |
27 MSSA 11 Streptococcus spp. 6 MRSA 5 MSSE 3 MRSE 3 Enterococcus spp. |
6 months | Clinical cure: 56.5% (overall bone and joint infections) Osteomyelitis: 60% Spondylodiscitis: 50% Acute septic arthritis: 100% Prosthetic joint infections: 38% Clinical failure: 23.9% |
NA | 8.7% (rash N = 2; nausea N = 1; hyperglycaemia N = 1) |
| Bouza et al., 201837 | Retrospective cohort study, multicentric | 33 | 20 Prosthetic joint infection 12 Osteomyelitis 1 Septic arthritis OPAT 73.9% |
97.1% (median 18 days) |
Dalbavancin 1500 mg single dose or 1000 mg (LD) + 500 mg |
16 CoNS 6 MRSA 4 MSSA 3 Enterococcus spp. 4 Others |
NA | Clinical success: 84.8% |
Relapse: 6.1% |
13.0% (2.9% serious) |
| Almangour et al., 201955 | Retrospective cohort study, multicentric | 31 | 31 Osteomyelitis Bacteraemic 32.3% |
84% (median 20 days) |
Dalbavancin 1500 mg + 1500 mg or 1000 mg LD + 500 mg weekly for up to 13 weeks or 1500 mg LD + 500 mg weekly for up to 3 weeks or 1000 mg x 2 followed by 500 mg weekly or 1500 mg single dose |
15 MRSA 12 MSSA 2 mixed gram-positive 1 CoNS 1 NA |
3 months after the completion of the antibiotic course | Clinical success: 90.3% |
Relapse: 3.2% |
None |
| Buzon Martin et al., 201957 | Retrospective cohort study | 16 | All prosthetic joint infections (8 total hip and 8 total knee arthroplasty infections) |
NA | Dalbavancin LD 1500 mg + 500 mg day 8 and then 500 mg biweekly or LD 1000 mg + 500–1000 mg/week |
7 CoNS 4 MRSA 4 E. faecium 4 E. faecalis |
503 days (median) |
Clinical success: 75% Clinical failure: 12.5% Mortality rate: 6.3% |
Relapse: 12.5% |
12.5% (not-serious; leukopenia N= 1; rash N= 1) |
| Bork et al., 201941 | Retrospective cohort study, multicentric | 15 (28 overall patients included in the study) |
13 Osteomyelitis 1 Prosthetic joint infection 1 Septic arthritis OPAT 100% |
100.0% (median 13.5 days) |
NA | 8 MRSA 6 MSSA 4 CoNS 8 Other 5 NA |
30–90 days | Overall clinical success: 71% (Bone and joint infection 50% at 30-day) |
NA | 10.7% (overall) |
| Almangour et al., 202056 | Retrospective matched-cohort study | 11 | 11 Osteomyelitis | No prior antibiotic treatment for >7 days | Dalbavancin 1500 mg day 1 + 1500 mg day 8 or 1000 mg LD + 500 mg weekly for 4–13 weeks vs Daptomycin or Vancomycin or Cefazolin |
6 MRSA 5 MSSA |
90 days | 90-day clinical cure: 100% (dalbavancin) vs 72.7% (SOC) [p = 0.062] |
None | None |
| Bryson-Cahn et al., 201935 | Retrospective cohort study | 10 | 7 Osteomyelitis 3 Septic arthritis OPAT 100.0% All drug injection users |
100.0% (range 1–29 days) |
Dalbavancin 1000 mg single dose or 1000 mg + 500 mg |
13 S. aureus | 30 days | Clinical cure: 60.0% (30.0% clinical failure; 10.0% lost to follow-up) |
NA | None |
| Nunez-Nunez et al., 201840 | Prospective observational | 10 (19 overall patients included in the study) |
6 Osteomyelitis 4 Implanted prosthetic device infection |
100% | Dalbavancin 1500 mg single dose or 1500 mg + 1500 mg or 1000 mg + 500 mg |
7 MRSA 6 CoNS 5 MSSA 1 E. faecalis 1 E. faecium |
90 days | Clinical success: 100.0% |
Relapse: 0.0% |
4.5% (not serious; overall) |
| Vazquez Deida et al., 202036 | Retrospective observational case series | 6 | 5 Osteomyelitis 1 Joint infection |
100.0% (range 28–35 days) |
1500 mg single dose | 3 MRSA 2 MSSA 1 GAS 1 MRSE |
90 days | Clinical success: 83.3% (16.7% clinical failure) |
Relapse: 0.0% |
7.0% (overall) |
| Durante-Mangoni et al., 20208 | Case report | 1 | Osteomyelitis with psoas abscess | Daptomycin + Rifampicin for 21 days and then Teicoplanin + Rifampicin for 7 days | Dalbavancin 1000 mg (day 1/8) + 500 mg/weekly for 6 weeks | Methicillin-resistant Staphylococcus haemolyticus | 9 months | Clinical success: 100.0% |
Relapse: 0.0% |
None |
| Molina Collada et al., 201763 | Case report | 1 | Septic arthritis in a native knee | Linezolid for 7 days and then Teicoplanin (duration not reported) | Dalbavancin 1500 mg single dose |
Corynebacterium striatum Dalbavancin MIC <0.125 mg/L |
6 months | Clinical success: 100.0% |
Relapse: 0.0% |
None |
| Azamgarhi et al., 201958 | Case report | 1 | Infected massive endoprosthetic replacement of the hip | Vancomycin + Ceftriaxone + Amikacin for 5 days | Dalbavancin 1500 mg for two doses |
MRSE Dalbavancin MIC <0.047 mg/L |
16 months | Clinical success: 100.0% |
Relapse: 0.0% |
None |
| Trujillano Ruiz et al., 201964 | Case report | 1 | Prosthetic infection of the hip | Vancomycin and then ciprofloxacin + rifampicin for 4 months, and then + Linezolid for 4 weeks | Dalbavancin 1000 mg LD + 500 mg/week for 3 weeks |
MRSE | 1 month | Clinical success: 100.0% |
Relapse: 0.0% |
None |
| Barbero Allende et al., 202165 | Case report | 1 | Femoral osteomyelitis after surgical intervention for osteosarcoma | Minocycline for 2 years | Dalbavancin 1500 mg every 4 weeks as long-term suppressive threapy |
MRSE | 2 years | Clinical success: 100.0% |
Relapse: 0.0% |
None |
| Loupa et al., 202059 | Case report | 1 | Diabetic foot osteomyelitis | Daptomycin + Tigecycline | Dalbavancin 1500 mg single dose at discharge and then linezolid for two weeks and tedizolid for one week 1500 mg second dose one month after the first |
E. faecium | 18 months | Clinical success: 100.0% |
Relapse: 0.0% |
None |
| Carrion Madronal et al., 202060 | Case report | 1 | Prosthetic infection of the hip | Vancomycin for two weeks, then linezolid for two weeks | Dalbavancin LD 1000 mg + 500 mg weekly for 7 weeks in combination with linezolid |
MRSE | 16 weeks | Clinical success: 100.0% |
Relapse: 0.0% |
None |
| Vates et al., 201861 | Case report | 1 | Spondylodiscitis D12-L1+ paravertebral abscess + ileo-femoral bypass vascular infection | Daptomycin + rifampicin for one month, then vancomycin | Dalbavancin LD 750 mg + 375 mg weekly for 7 weeks |
MRSA | NA | Clinical success: 100.0% |
Relapse: 0.0% |
None |
| Almangour et al., 201762 | Case report | 1 | Native vertebral osteomyelitis with bacteraemia | Vancomycin and then daptomycin for a total of 12 weeks | Dalbavancin 1000 mg/week for 2 weeks + 500 mg/week for additional 6 weeks | MRSA | 3 months | Clinical success: 0.0% |
Relapse: 100.0% (MRSA bacteraemia) |
None |
| Ramirez-Hidalgo et al., 201866 | Case report | 1 | Prosthetic knee infection | Daptomycin for 10 days | Dalbavancin LD 1000 mg weeks + 500 mg/week for 3 weeks | MRSE Dalbavancin MIC <0.047 mg/L |
9 months | Clinical success: 100.0% |
Relapse: 0.0% |
None |
| Alvarez-Otero et al., 201967 | Case report | 1 | Acromioclavicular arthritis associated with bacteraemic multiple pyomyositis and subcutaneous abscesses | Cloxacillin + Clindamycin for 5 weeks | Dalbavancin 1500 mg + 1500 mg one month later |
MSSA | NA | Clinical success: 100.0% |
Relapse: 0.0% |
None |
Abbreviations: AEs, adverse events; CoNS, coagulase-negative Staphylococcus; GAS, group A Streptococcus; LD, loading dose; MRSE, methicillin-resistant Staphylococcus epidermidis; MSSE, methicillin-susceptible Staphylococcus epidermidis; MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus; NA, not available; OPAT, outpatient parenteral antimicrobial therapy; SOC, standard-of-care.