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.