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Table 2 Comparison of long acting lipoglycopeptide studies that included persons who use drugs

From: Oritavancin for the treatment of complicated gram-positive infection in persons who inject drugs

Citation, year, LAL(s) Patients Organisms Indications Number of doses Results Outcomes & Definitions
Stewart et al. 2017 [12]
ORI
Total: 10
▪ PWID: 4 (40%)
PWID only
▪ Males: 0
▪ Average age: 37 years (range 26–53)
PWID
▪ MSSA: 2
▪ GBS: 1
▪ Enterococci: 1
PWID
▪ GBS BSI + IE
E. faecalis BSI
▪ BSI + bone/joint
▪ BSI + psoas abscess
PWID
▪ 1 dose = 4/4
PWID (n = 4)
▪ Cure: 1/4
▪ Failure: 2/4
▪ LTFU: 1/4
Clinical cure: resolution of all clinical signs/symptoms of infection (afebrile, normalization of WBC/ESR), no additional infection-related hospital admissions, no additional antibiotic therapy required for the initial indication treated with ORI, infection clearance with sterile blood cultures where indicated.
Failure: worsening of current infection or new/recurrent signs or symptoms of infection requiring a change in antibiotics or additional antibiotic therapy.
Not clinically evaluable: patients who were LTFU.
ADRs: based on reporting by prescribing physician and follow-up with patients after administration (timeframe not specified).
Morrisette et al. 2019 [14]
DAL + ORI
Total: 56
▪ PWUD: 17 (30%)
PWUD only
▪ Males: 12 (71%)
▪ Average age: 34.5 years (SD + 10.9)
▪ DAL: 12 /17
▪ ORI: 4/17
▪ Both: 1/17
PWUD
▪ MSSA: 8 (47%)
▪ MRSA: 5 (29%)
E. faecalis: 1 (6%)
▪ VRE: 1 (6%)
▪ Other: 2 (12%)
(unknown or mixed)
PWUD
▪ ABSSSI: 6 (35%)
▪ OM: 6 (35%)
▪ IE: 3 (18%)
▪ Other: 2 (12%)
PWUD
▪ Median = 1 (IQR 1–2)
PWUD (n = 17)
▪ Success: 13/17 (77%)
▪ Failure: 1/17 (6%)
▪ Unknown: 3/17
1 patient counted as both a failure and success as they failed oritavancin but were subsequently cured with dalbavancin.
Clinical success: no further clinical or microbiological evidence of active infection (resolution of signs/symptoms related to bacterial infection and clearance of cultures if applicable) without need for further gram-positive therapy due to clinical worsening within 60 days of last dose of LAL.
Clinical failure: lack of clinical response, relapse with the primary infection within 60 days of last LAL dose, need for alternative gram-positive therapy due to clinical worsening during LAL therapy, or death.
ADRs: any potential ADR occurring during or within 7 days of LAL infusion.
Bork et al. 2019 [15]
DAL
Total: 28
▪ PWUD: 19 (68%)
▪ PWID: 16/19 (57%)
All patients
▪ Males: 26 (93%)
▪ Median age: 52 years (IQR 21.5)
All patients
▪ MRSA: 8 (29%)
▪ MSSA: 6 (21%)
▪ CoNS: 4 (14%)
▪ Mixed GP: 8 (29%)
▪ Unknown: 5 (18%)
All patients
▪ Bone: 13 (46%)
▪ Endovascular: 6 (21%)
▪ BSI: 4 (14%)
▪ Other: 5 (18%)
All patients
▪ Average = 3
▪ Site 1: 1.5
▪ Site 2: 5.5
Substance Abusers (n = 19)
▪ Success: 10/13 (77%)
▪ Failure: 3/13 (23%)
▪ LTFU: 6/19
Primary outcome: proportion of patients with 30 day clinical cure (30 days after planned DAL course).
Secondary outcomes: 90 day clinical cure; ADRs
Clinical cure: composite of resolution of clinical signs of infection (erythema, swelling, pain); afebrile; normalization of CRP/ESR/WBC; source control; resolution of radiographic signs of infection and/or microbiologic clearance of organisms. If readmitted for infection then considered failure.
Clinical failure: due to (1) death, (2) intolerance or AE, (3) lack of access to subsequent DAL, (4) lack of source control, (5) worsening signs of infection or relapse.
ADRs: anything likely to be associated w/ DAL based on specific ADE and temporal relationship with DAL (specific timeframe not provided).
Bryson-Cahn et al. 2019 [16]
DAL
Total: 32
▪ PWUD: 32 (100%)
▪ PWID: 28 (88%)
▪ Homeless: 15 (47%)
All patients (PWUD)
▪ Males: 23 (72%)
▪ Average age: 38 years (IQR 25–50)
PWUD
▪ MRSA: 28 (88%)
▪ In the IE group:
-MSSA = 2
-MRSA = 7
Other organisms not reported.
PWUD
▪ IE: 9
▪ BSI: 14
- Joint: 2
- Epidural abscess: 3
- Thrombophlebitis: 2
▪ Bone: 7
- Spine: 3
- Extremity: 4
▪ Joint: 2
(without BSI)
PWUD
▪ 1 dose = 22
▪ 2 doses = 7
▪ 3 doses = 2
▪ 5 doses = 1
PWUD (n = 32)
▪ Success: 18/32 (56%)
▪ Failure: 4/32 (13%)
▪ LTFU: 10/32 (31%)
▪ Completed therapy: 17/32 (53%)
Clinical response: patient had a follow-up visit within 1 year at HMC or a neighboring hospital, linked through a common EMR, without evidence for an ongoing or relapsed infection, regardless of whether they completed the intended course of therapy.
LTFU: patient did not have a subsequent encounter to evaluate their infection at either the ID clinic or another institution linked via EMR within 1 year.
All-cause readmission: hospital readmission within 30 days from previous discharge.
ADRs: not defined/reported.
Brownell et al. 2020 [13]
ORI
Total:
▪ 75 safety analysis
▪ 73 efficacy analysis
▪ PWID: 10 (13.3%)
All patients:
▪ MSSA: 23 (31.5%)
▪ MRSA: 13 (17.8%)
▪ CoNS: 4 (5.8%)
▪ VRE: 4 (5.8%)
All patients:
ABSSSI: 25
Diabetic foot infection: 3
IE: 4
Line infection: 2
Other: 5
OM/Septic arthritis: 10
Pneumonia: 5
Prosthetic device infection: 3
Sepsis: 5
Surgical wound infection: 12
PWID: numbers not reported
OM, IE, Prosthetic device infection, Surgical wound infection
All patients:
1–32
All patients: n = 73
Cure: 34/73 (46.6%)
Improvement: 34/73 (46.6%)
Failure: 5/73 (6.8%)
PWID (n = 10)
Cure or improvement: 7/10 (70%)
Clinical outcomes were reviewed within 28 days of the end of therapy. Safety outcomes were reviewed out to 30 days after ORI.
Clinical cure: resolution of signs and symptoms of infection without the need for further treatment after the completion of ORI
Clinical improvement: recovery from infectious signs and symptoms with the need for subsequent gram-positive therapy after the completion of the ORI
Clinical failure: progression of infectious signs and symptoms and need for alternative gram-positive therapy during the ORI course
Ahiskali et al. 2020
ORI
Total = 24
▪ PWUD: 24 (100%)
▪ PWID: 24 (100%)
▪ Homeless: 16 (67%)
All patients (PWUD)
▪ Males: 16 (70%)
▪ Average age: 41 years (range 22–64)
PWUD
▪ MRSA: 14 (58%)
▪ MSSA: 8 (33%)
▪ Streptococci: 2
▪ Unknown: 1
PWUD
▪ Bone/Joint: 14
- Bone: 9
Spine: 5/9
- Joint: 5
▪ BSI: 12
▪ IE: 2
Patients may be counted in multiple categories.
PWUD
▪ 1 dose = 13
▪ 2 doses = 7
▪ 3 doses = 1
▪ 4 doses = 1
▪ 6 doses = 2
PWUD (n = 24)
▪ Success: 19/24 (79%)
- I/C = 5
▪ Failure: 3/24 (13%)
- I/F = 1
▪ LTFU: 2/24 (8%)
▪ Completed therapy:  19/24 (79%)
▪ Outcomes were reviewed out to 60 days after the final ORI infusion.
Clinical cure: resolution of signs and symptoms of infection (fever, WBC, ESR) without need for additional antimicrobial therapy following completion of ORI (excluding long term suppressive antibiotics for retained hardware).
Failure: progression of infection and need for alternative therapy.
Incomplete cure/failure: incomplete adherence to therapy.
LTFU: no notes or data available in EMR after final ORI dose.
ADRs: collected up to 6 weeks from last dose or until LTFU.
  1. Abbreviations: ABSSSI acute bacterial skin and skin structure infection, BSI bloodstream infection, CC clinical cure, CoNS coagulase-negative staphylococci, DAL dalbavancin, EMR electronic medical record, ESR erythrocyte sedimentation rate, GBS Group B Streptococcus, GP gram-positive, HW hardware, IE infective endocarditis, I/C incomplete adherence with cure, I/F incomplete adherence with failure, , IQR interquartile range, LTFU lost to follow-up, MSSA methicillin-susceptible Staphylococcus aureus, MRSA methicillin-resistant Staphylococcus aureus, OM osteomyelitis, ORI oritavancin, PWID persons who inject drugs, PWUD persons who use drugs, VRE vancomycin-resistant Enterococcus faecium, WBC white blood cell count