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Necrotizing Fasciitis Within 72 hours After Presentation with Skin and Skin Structure Infection
Urania Rappo1, H Bryant Nguyen2, Sailaja Puttagunta1,3
1Allergan PLC, Madison, New Jersey.
Introduction:
A small percentage of patients with skin infections later develop necrotizing fasciitis (NF). Diagnostic testing is needed to identify patients with skin infections at low risk of NF who could be discharged from the emergency department (ED) after antibiotic initiation. Elevated lactate has been associated with NF; existing estimates of the frequency of NF are based on retrospective reviews, and cases often lack testing for lactate. We present the incidence of patients with skin infections who developed NF and their baseline lactates.
Methods:
In four phase-3 trials, 2883 adults with complicated or acute bacterial skin and skin structure infections were randomized to dalbavancin or comparator, with early and late follow-up visits through Day 28. We prospectively collected baseline plasma lactates in one trial to assess an association with NF.
Results:
NF was diagnosed in 3/2883 patients (0.1%); all three survived. In the study with prospectively collected baseline lactates (n = 622), 15/622 (2.4%) had a lactate ≥4 millimoles per liter (mmol/L), including 3/622 (0.5%) with a lactate ≥7 mmol/L. NF was not seen in patients with a lactate <4 mmol/L; NF was seen in 1/15 (6.7%) with a lactate ≥4 mmol/L, including 1/3 (33.3%) with lactate ≥7 mmol/L.
Conclusions:
NF incidence within 72 hours of antibiotic initiation in patients with complicated or acute bacterial skin and skin structure infections was extremely low (0.1%) and occurred in 6.7% with a lactate ≥4 mmol/L. Lactate <4 mmol/L can be used to identify patients at low risk of NF who could be safely discharged from the ED after antibiotic initiation.
Insights
Necrotizing fasciitis (NF) is rare in skin infection patients, occurring in 0.1%. A baseline lactate level below 4 mmol/L can identify patients at low risk for NF, allowing safe emergency department discharge after antibiotic initiation.
Area of Science:
- Infectious Diseases
- Emergency Medicine
- Clinical Diagnostics
Background:
- Necrotizing fasciitis (NF) is a severe complication of skin infections.
- Accurate risk stratification is needed for patients with skin infections in the emergency department (ED).
- Elevated lactate levels are associated with NF, but data on incidence and baseline lactate levels are limited.
Purpose of the Study:
- To determine the incidence of NF in patients with skin infections.
- To assess the association between baseline lactate levels and the development of NF.
- To identify a reliable biomarker for safely discharging low-risk patients from the ED.
Main Methods:
- Analysis of data from four phase-3 clinical trials involving 2883 adults with skin infections treated with dalbavancin or comparator.
- Prospective collection of baseline plasma lactate levels in a subset of 622 patients.
- Evaluation of NF development based on baseline lactate concentrations (≥4 mmol/L and ≥7 mmol/L).
Main Results:
- The overall incidence of NF was 0.1% (3/2883 patients).
- In the prospectively studied cohort (n=622), 2.4% had lactate ≥4 mmol/L and 0.5% had lactate ≥7 mmol/L.
- NF did not occur in patients with lactate <4 mmol/L; however, 6.7% of patients with lactate ≥4 mmol/L developed NF.
Conclusions:
- The incidence of NF within 72 hours of antibiotic initiation for skin infections is very low (0.1%).
- A baseline lactate level <4 mmol/L is a strong indicator of low risk for developing NF.
- Lactate levels can aid in identifying patients with skin infections who are safe for discharge from the ED post-antibiotic initiation.
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