Linezolid use in the treatment of vancomycin-resistant Enterococcus in paediatric patients
Abstract number: P1555
Deville J., Goldfarb J., Kaplan S., Equils O., Huang D., Ang J., Salazar J.
Objective: Vancomycin-resistant Enterococcus (VRE) is a difficult to treat pathogen in hospitalised paediatric patients. Our objective was to assess the efficacy and safety of linezolid (LZD) for treatment of VRE infections in paediatric patients.
Methods: Hospitalised children with VRE infection were enrolled in a multicentre, open-label, noncomparator study from 20022004, as an extension to the parent study of LZD vs vancomycin for treatment of resistant Gram-positive infections in children. Patients less than 11 y received LZD 10 mg/kg (up to 600 mg) every 8 h; all others received LZD 600 mg every 12 h. Intravenous (IV) treatment was required for the first 3 d, and then oral LZD could be used, at the discretion of the investigator. The primary efficacy measures were the patients' clinical outcomes at test of cure (TOC; 1228 d after treatment completion). Safety measures included reported adverse events (AE).
Results: Thirteen seriously ill children aged 4 m to 17 y (mean±SD: 7 y±6.4 y) were enrolled. Primary baseline infections were vascular associated bacteraemia (n = 4), bacteraemia of unknown source (n = 3), urinary tract infection (n = 3), skin and skin structure infection (SSI, n = 1), pyelonephritis (n = 1) and intra-abdominal abscess (n = 1). In 69% (9/13) of the patients, vancomycin-resistant (VR) E. faecium was isolated, 1 had VR E. faecalis, 1 had vancomycin-intermediate (VI) E. faecium and VI E. gallinarum, 2 had vancomycin-susceptible E. faecium, 1 also had E. gallinarum; however, no susceptibility testing was performed on the latter because of insufficient culture sample. Mean treatment duration of LZD was 17.1±7.2 d. At the TOC, the clinical cure rate was 8/12 (66.7%) for the intent-to-treat population (1 was withdrawn from the study per protocol exclusionary criteria) and 5/7 (71.4%) for the microbiologically evaluable group (culture-confirmed VRE infections). Three patients had drug-related AE (diarrhoea, anaemia, decreased cyclosporine level). One patient discontinued LZD due to AE (abdominal distention and pain, diarrhoea, and anaemia). Two patients died during the study but neither death was related to LZD (end-stage liver disease and end-stage renal disease waiting for a heart transplant). Changes in haematology and chemistry parameters were consistent with the underlying disease states and were largely transient.
Conclusion: LZD was effective and well tolerated in treating severely ill children with VRE infections.
|Session name:||Abstracts 20th European Congress of Clinical Microbiology and Infectious Diseases|
|Location:||Vienna, Austria, 10 - 13 April 2010|
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