2.1 | Study design
This was a single-center, non-blinded, RCT conducted over 36 months (June 1, 2017–June 1, 2020). Children aged between 1 to 144 months, requiring vancomycin therapy were considered regardless of sex, religion, or nationality. The two main conditions of subjects were considered in the experimental scheme: (1) Hospitalized patients over 1 month-old in ICU; (2) Serious infection caused by the gram-positive bacteria was suspected or confirmed by clinical symptoms, signs, laboratory tests, and having indications for the treatment with vancomycin. The exclusion criteria for this study included: (1) Known glycopeptide allergy; (2) Renal impairment before vancomycin treatment; (3) Infants receiving vancomycin or other glycopeptide administration such as norvancomycin, teicoplanin, linezolid, and rifampicin for more than 24 h, in the previous 72 h; (4) The drugs had a synergistic effect which affects the judgment of curative effect; (5) The combination of drugs with nephrotoxicity affecting the safety assessment; (6) Extracorporeal membrane oxygenation, continuous renal replacement therapy; or (7) The guardian refused to cooperate.
The study was approved by the Capital Institute of Pediatrics Research Ethics Committee (SHERLL2016090) and the registration number is ChiCTR2100043659 for the clinical trial registration.