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Linezolid Better Tolerated, As Effective As Vancomycin In Treating Resistant Gram-positive Paediatric Infections

Linezolid treatment for resistant Gram-positive infections in hospitalised children is effective equally to vancomycin with fewer adverse effects, according to a recent report from the Baylor College of Medicine and Texas Children's Hospital, United States.

A recent increase in resistant paediatric infections has created a concern for treatment options. Linezolid, an oxazolidinone, has been shown to have in vitro bactericidal activity against pneumococci and bacteriostatic activity for staphylococci and enterococci, including methicillin- and vancomycin-resistant strains.

Investigators, led by Sheldon L. Kaplan, MD, performed a study to assess the clinical efficacy, safety and tolerability of linezolid versus vancomycin for known or suspected antibiotic-resistant Gram-positive infections in hospitalised children under 12 years of age.

The patients were randomised (2:1) to receive either intravenous linezolid 10 mg/kg every 8 hours (N=215, mean age=2.19 + 3.16 years) or intravenous vancomycin 10 to 15 mg/kg every 6 to 24 hours (N=101, mean age=2.94 + 3.13 years) for at least 3 days. After 3 days, patients older than 91 days receiving linezolid could be switched to oral linezolid suspension (10 mg/kg every 8 hours), and those in the vancomycin group could have treatment changed to an appropriate oral antibiotic agent. Treatment was continued for up to 28 days.

According to Dr. Kaplan, no significant differences were detected between the rates of clinical cure for the two treatments. In addition, the pathogen eradication rates were high for both treatments, and no significant differences were detected in the microbiologically evaluable population.

For patients who had received at least one dose of treatment, the cure rates were 79.1% and 74.1% for linezolid and vancomycin, respectively (P=0.36). In patients who received greater than 80% of the prescribed medication, the cure rates rose to 89.3% for linezolid and 84.5% for vancomycin (P=0.31).

Despite the similar efficacies, several benefits were detected for linezolid treatment compared to vancomycin. The mean duration of treatment was 1 day shorter for the linezolid (11.3 + 5.0 days) than vancomycin (12.2 + 6.4 days). Furthermore, drug-related adverse events were statistically more frequent in the vancomycin group (34.3%) than for linezolid treatment (18.8%; P=0.0026), resulting in a greater rate of study withdrawal (vancomycin, 6.1%; linezolid, 0.9%; P=0.0077).

"Empiric intravenous and oral linezolid [is] as effective as vancomycin with significantly fewer drug-related adverse events," the researchers conclude, adding that linezolid "may offer advantages as an alternative to vancomycin for infections in children."
Pediatr Infect Dis J, 2003;22:8:677-85. "Linezolid versus vancomycin for treatment of resistant Gram-positive infections in children"

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