Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infection in Patients With Obesity or Diabetes: A Subgroup Analysis of Pooled Phase 3 Clinical Trials.
Open Forum Infect Dis
; 10(6): ofad256, 2023 Jun.
Article
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| MEDLINE
| ID: mdl-37305839
ABSTRACT
Background:
We assessed the efficacy and safety of dalbavancin, a long-acting lipoglycopeptide with activity against Gram-positive pathogens, for treatment of acute bacterial skin and skin structure infections (ABSSSI) in patients with high body mass index (BMI) and/or diabetes.Methods:
Data from two phase 3 trials of dalbavancin (1000â mg intravenous [IV], day 1; 500â mg IV, day 8) versus comparator and one phase 3b trial of single-dose (1500â mg IV, day 1) versus 2-dose (1000â mg IV, day 1; 500â mg IV, day 8) dalbavancin in adults with ABSSSI were pooled and summarized separately by baseline BMI and diabetes status. Clinical success at 48 to 72â hours (≥20% reduction in lesion size), end of treatment ([EOT] day 14), and day 28 was evaluated in the intent-to-treat (ITT) and microbiological ITT (microITT) populations. Safety data were reported in patients who received ≥1 dose of study drug.Results:
In the dalbavancin ITT population (BMI, n = 2001; diabetes, n = 2010), at 48 to 72â hours (and EOT) clinical success was achieved in 89.3% (EOT, 90.9%) of patients with normal BMI and 78.9% to 87.6% (EOT, 91.0% to 95.2%) of patients with elevated BMI. Clinical success after dalbavancin treatment was achieved in 82.4% (EOT, 90.8%) of patients with diabetes and 86.0% (EOT, 91.6%) of patients without diabetes. Similar trends were observed for infections due to methicillin-resistant Staphylococcus aureus or methicillin-susceptible S aureus (microITT population).Conclusions:
Dalbavancin is effective, with sustained clinical success rates in patients with obesity or diabetes, with a similar safety profile across patient groups.
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MEDLINE
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Open Forum Infect Dis
Año:
2023
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Article