Single-dose Dalbavancin Research Articles

Single Intravenous Dose Dalbavancin Pathway for the Treatment of Acute Bacterial Skin and Skin Structure Infections: Considerations for Emergency Department Implementation and Cost Savings

BackgroundA pathway for the treatment of acute bacterial skin and skin structure infections (ABSSSI) with a single intravenous (IV) dose of dalbavancin was previously shown to reduce hospital admissions and shorten inpatient length of stay (LOS). ObjectivesTo describe pathway implementation at the emergency department (ED) and evaluate cost-effectiveness of a single-dose dalbavancin administered to ED patients who would otherwise be hospitalized to receive usual care with multidose IV antibiotics. MethodsThe dalbavancin pathway was previously implemented at 11 U.S. EDs (doi:10.1111/acem.14258). Patients with ABSSSI, without an unstable comorbidity or infection complication requiring complex management, were treated with a single dose of dalbavancin. At the emergency physicians’ discretion, patients were either discharged and received outpatient follow-up or were hospitalized for continued management. A decision analytic cost-effectiveness model was developed from the U.S. healthcare's perspective to evaluate costs associated with the dalbavancin pathway compared with inpatient usual care. Costs (2021 USD) were modeled over a 14-day horizon and included ED visits, drug costs, inpatient stay, and physician visits. One-way and probabilistic sensitivity analyses examined input parameter uncertainty. ResultsDriven largely by the per diem inpatient cost and LOS for usual care, the dalbavancin pathway was associated with savings of $5133.20 per patient and $1211.57 per hospitalization day avoided, compared with inpatient usual care. The results remained robust in sensitivity and scenario analyses. ConclusionThe new single-dose dalbavancin ED pathway for ABSSSI treatment, which was previously implemented at 11 U.S. EDs, offers robust cost savings compared to inpatient usual care.

Dalbavancin in catheter-related bloodstream infections: a pilot study.

Catheter-related bloodstream infections (CRBSI) represent a frequent complication of vascular catheterization, with high morbidity, mortality, and associated costs. Most infections are caused by Gram-positive bacteria; thus dalbavancin, a new long-acting lipoglicopeptide, may have a role in early patient discharge strategies optimizing treatment and reducing overall costs. In this small pilot feasibility study, we assessed the efficacy and safety of a "single step" treatment strategy combining dalbavancin administration (1500 mg IV single dose), catheter removal, and early discharge in adult patients admitted to medical wards in a three-year period. We enrolled sixteen patients with confirmed Gram-positive CRBSI, with a mean age of 68 years and relevant comorbidities (median Charlson Comorbidity index=7). The most frequent causative agents were staphylococci, with 25% of methicillin-resistant strains, and the majority of infected devices were short term central venous catheter (CVC) and peripherally inserted central catheter (PICC). Ten out of sixteen patients had been treated empirically before dalbavancin administration. The mean time from dalbavancin administration to discharge was 2 days; none of the patients had adverse drug-related reactions; at 30- and 90-day follow-up, no patients have been readmitted to the hospital due to bacteraemia recurrence. Our results indicate that single-dose dalbavancin is highly effective, well-tolerated, and cost-saving for Gram-positive CRBSI.

Cost-Consequence Analysis of Single-Dose Dalbavancin Versus Standard of Care for the Treatment of Acute Bacterial Skin and Skin Structure Infections in a Multisite Healthcare System.

Acute bacterial skin and skin structure infections (ABSSSIs) are common infectious diseases that cause a significant economic burden on the healthcare system. This study aimed to compare the cost-effectiveness of dalbavancin vs standard of care (SoC) in the treatment of ABSSSI in a community-based healthcare system. This was a retrospective study of adult patients with ABSSSI treated with dalbavancin or SoC during a 27-month period. Patients were matched based on age and body mass index. The primary outcome was average net cost of care to the healthcare system per patient, calculated as the difference between reimbursement payments and the total cost to provide care to the patient. The secondary outcome was proportion of cases successfully treated, defined as no ABSSSI-related readmission within 30 days after the initiation of treatment. Of the 418 matched patients, 209 received SoC and 209 received dalbavancin. The average total cost of care per patient was greater with dalbavancin vs SoC ($4770 vs $2709, P < .0001). The average reimbursement per patient was $3084 with dalbavancin vs $2633 SoC (P = .527). The net cost, calculated as revenue minus total cost, was $1685 with dalbavancin vs $75 with SoC (P = .013). The overall treatment success rate was 74% with dalbavancin vs 85% with SoC (P = .004). Dalbavancin was more costly than SoC for the treatment of ABSSSI, with a higher 30-day readmission rate. Dalbavancin does not offer an economic or efficacy advantage.

Acute Bacterial Skin and Skin-Structure Infections, efficacy of Dalbavancin: a systematic review and meta-analysis

ABSTRACT Objectives To know the efficacy of different doses of dalbavancin in acute bacterial skin and skin-structure infections (ABSSSIs) and versus other antibiotics. Methods We performed a systematic review of dalbavancin efficacy for ABSSSIs. We selected 10 clinical trials from MEDLINE and Cochrane databases for qualitative review. Of these, five trials compared one or two doses of dalbavancin versus other antibiotics such as vancomycin or linezolid. Results Treatment outcomes with other antibiotics were not significantly different versus two doses of dalbavancin (OR 1.13; 95% CI 0.75–1.71; p = 0.55) or single dose dalbavancin (OR 0.98; 95% CI 0.19–5.17; p = 0.98). One dose versus two doses of dalbavancin did not show significant differences in any of the treatment groups. In contrast, the global microbiological assessment results indicated a favorable outcome for two doses of dalbavancin compared to the single dose of dalbavancin (OR 2.96; 95% CI 1.19–7.39; p = 0.02) in both methicillin-resistant and methicillin-susceptible Staphylococcus aureus. Conclusion Either single dose or two dose dalbavancin treatment is as clinically effective as other antibiotics such as vancomycin and linezolid for the treatment of ABSSSIs. Abbreviations ABSSI: acute bacterial skin and skin-structure infection; AUC: area under the concentration-time curve; CE: clinical evaluable; CI: confidence interval; EOT: end of treatment; ITT: intention-to-treat; LOS: length of stay; MIC: minimum inhibitory concentration; MIC90: minimum concentration to inhibit growth of 90% of isolates; MR: methicillin resistant; MRSA: methicillin-resistant Staphylococcus aureus; MS: methicillin susceptible; MSSA: methicillin-susceptible Staphylococcus aureus; OPAT: Outpatient Parenteral Antimicrobial Therapy; OR: odds ratio; PI: penicillin intermediate; PR: penicillin resistant; PS penicillin susceptible; SIRS: systemic inflammatory response syndrome; SSTI: skin and soft tissue infection; TOC: test of cure; VR: vancomycin resistant; VS: vancomycin susceptible.

Use of a telehealth follow-up system to facilitate treatment and discharge of emergency department patients with severe cellulitis.

Novel long-acting lipoglycopeptide antibiotics allow for the treatment and discharge of selected emergency department (ED) patients with cellulitis who require intravenous antibiotics. Telehealth systems have shown success in remote management of dermatologic conditions; we implemented a telehealth follow-up program for patients diagnosed with cellulitis in the ED, treated with single-dose dalbavancin, and discharged. This was a prospective, multi-center observational study. Patients were included based on clinical criteria and ability to complete follow-up using a smartphone and enroll in an online care portal. We examined the rate of successful telehealth follow-up at 24- and 72-hour intervals from discharge. We also examined the ED return rate within 14days, reviewed any visits to determine cause of return, and for admission. 55 patients were enrolled. 54/55 patients completed at least one telehealth follow up encounter (98.2%). 13 patients (23.6%) had a return ED visit within 14days; no patients required admission for worsening cellulitis. Patient engagement in the telehealth program decreased over time; there was an approximately 11% decrease in engagement between the 24 and 72-hour follow-up call, and a 15% decrease in engagement between the 24 and 72-hour image upload. Patients over 65 had a lower rate of image upload (31%) than younger patients (80.6%). A telehealth follow-up system for discharged emergency department patients with cellulitis demonstrated high rates of engagement. In these patients who -may have otherwise required admission for intravenous antibiotics, telehealth-facilitated outpatient management resulted in a low ED return rate and no inpatient admissions for cellulitis.

Single-dose dalbavancin and patient satisfaction in an outpatient setting in the treatment of acute bacterial skin and skin structure infections

Treatment of acute bacterial skin and skin structure infections (ABSSSIs) in the outpatient setting has potential advantages. We performed a subanalysis of outcomes for patients treated as outpatients versus inpatients with dalbavancin, a long-acting lipoglycopeptide, in a phase 3 clinical trial of ABSSSI. The study was a double-blind trial of patients with ABSSSI randomised to receive dalbavancin 1500 mg intravenously as a single dose or two doses (1000 mg followed by 500 mg a week later). The primary endpoint was ≥20% reduction in erythema at 48-72 h after the start of therapy. Patient satisfaction and preference for antibiotic treatment and care setting were measured using the 10-item Skin and Soft Tissue Infection (SSTI) questionnaire at Day 14. A total of 698 patients were randomised (386 treated as outpatients and 312 as inpatients). Outpatients were more likely to be younger and to have major abscess or traumatic wound infection; inpatients were more likely to have cellulitis as the type of ABSSSI, to meet SIRS criteria and to have elevated plasma lactate at baseline. Efficacy and safety outcomes at 48-72 h, Days 14 and 28 were similar between patients treated in the outpatient and inpatient setting with either the single-dose or two-dose regimen. Outpatients reported significantly greater convenience and satisfaction with antibiotic treatment and care setting compared with inpatients (P < 0.001). Single-dose dalbavancin is an effective treatment option for outpatients with ABSSSI and is associated with a high degree of patient treatment satisfaction and convenience.

Treatment of acute bacterial skin and skin structure infection with single-dose dalbavancin in persons who inject drugs.

BackgroundPersons who inject drugs (PWID) are at increased risk of acute bacterial skin and skin structure infections (ABSSSIs), a growing healthcare concern. Multiple medical, social, and economic issues, including adherence and comorbidities, complicate the medical care of the PWID population, adversely affecting patient outcomes.MethodsWe assessed demographics and outcomes for the PWID population in a double-blind trial of 698 patients randomized to dalbavancin 1500 mg as a single intravenous (IV) infusion or as a 2-dose regimen (1000 mg IV on day 1; 500 mg IV on day 8) for ABSSSI. The primary endpoint was ≥20% reduction in erythema at 48–72 hours in the intent-to-treat population; clinical status was also assessed at days 14 and 28.ResultsThere were 212/698 (30.4%) patients with a history of injection drug use in this clinical trial. Dalbavancin efficacy was similar between the single- and 2-dose therapy groups in the PWID and non-PWID populations at all timepoints. Dalbavancin was well tolerated in the PWID population, with similar rates of adverse events as the non-PWID population.ConclusionDalbavancin as a single-dose or 2-dose regimen had similar efficacy for the treatment of ABSSSI at all timepoints in the PWID and non-PWID populations. A single 30-minute IV infusion would eliminate the need for indwelling IV access. The convenience of a single dose supervised in a health setting may also optimize treatment adherence in the PWID population.

Pharmacist-Directed Use of Dalbavancin in Acute Bacterial Skin and Skin Structure Infections to Reduce Hospital Length of Stay

BackgroundAcute bacterial skin and skin structure infections (ABSSSI) are a rapidly increasing cause of hospitalization. Prolonged length of stay (LOS) increases the cost burden to health systems due to administration of parenteral antimicrobials. Dalbavancin is a lipoglycopeptide providing a full course of therapy with one dose and is indicated for the treatment of patients with ABSSSI and presents a unique opportunity for cost avoidance by decreasing inpatient LOS and shifting care to the outpatient setting. This study evaluated the practice of a pharmacist-directed model for discharging hospitalized patients with ABSSSI to receive intravenous dalbavancin at a hospital outpatient infusion center.MethodsA quasi-experimental investigation of an ongoing, prospective process with open enrollment for patients discharged to receive single-dose dalbavancin therapy between March 2016 and March 2017. To be eligible, adult patients must have been admitted with an ABSSSI based upon inclusion and exclusion via International Classification of Diseases codes. Subjects were compared with a cohort of patients from March 2015 through March 2016 (comparator group) meeting the same criteria for inclusion and exclusion. The primary outcome is hospital LOS and secondary outcomes are cost-savings associated with a reduced LOS and hospital readmission within 30 days of discharge.ResultsFifty-three patients were identified who received dalbavancin during the enrollment period, and 44 were included in the study. In the comparator group 1191 patients were identified of which 945 were included in the study. Hospital LOS (4.3 vs. 8.0, P < 0.001) and total direct cost per case ($7,863 vs. $2,989, P < 0.001) were statistically significantly decreased for the dalbavancin group compared with the comparator group. Readmission rates at 30 days were similar between the dalbavancin and comparator groups (11.4% vs. 8.6%, P = 0.34).ConclusionPatients discharged to an outpatient infusion center to receive dalbavancin had a decreased LOS and total direct cost per case in relation to the comparator group of standard of care. No statistically significant difference in readmission rates was observed. Early goal-directed discharge for the treatment of patients with ABSSSI is a safe and effective way to decrease LOS.Disclosures B. Jones, Allergan: Speaker’s Bureau, Speaker honorarium

Single-Dose Dalbavancin: A Review in Acute Bacterial Skin and Skin Structure Infections.

Intravenous dalbavancin (Dalvance®, Xydalba®), first approved as a two-dose regimen for the treatment of acute bacterial skin and skin structure infections (ABSSSI), has now been additionally approved as a single-dose regimen. This narrative review discusses the pharmacological properties of intravenous dalbavancin and its clinical efficacy and tolerability as a single-dose regimen in the treatment of adult patients with ABSSSI. Single-dose dalbavancin is an effective and generally well tolerated treatment option for adults with ABSSSI, with noninferior efficacy to the two-dose dalbavancin regimen with regard to early clinical response (at 48-72h) and low rates of adverse events. Clinical success rates at days 14 and 28 also did not significantly differ between the single- and two-dose dalbavancin regimens; neither did clinical success rates at day 14 when analysed by baseline pathogen. It has a broad spectrum of activity against common ABSSSI-related pathogens, and a favourable pharmacokinetic profile allowing for the convenience of single-dose administration. Thus, dalbavancin presents a promising alternative to conventional antibacterials for the treatment of ABSSSI in adult patients.