Pneumonia Gram-Positive Bacterial Clinical Trial
Official title:
A Retrospective Study of Relationships Between Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections Treated With Teicoplanin
This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from February 2015 to August 2016.
1. Patients and protocol This was a retrospective study that all teicoplanin-treated adult
patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated
to Zhengzhou University from February 2015 to August 2016. Patients were included who
met the following criteria: (1) age≥18 years, (2) duration of teicoplanin therapy≥5
days, (3) written informed consent was obtained from each patients. Patients were
excluded who fulfilled any of the following criteria: (1) Patients who were allergy to
teicoplanin, (2) pregnant women, (3) patients with hematopoietic function, (4) patients
unable to evaluate efficacy and safety. This study was approved by the research ethics
committee of the Zhengzhou Central Hospital affiliated to Zhengzhou University.
2. Treatment regimen and groups According to CLcr and teicoplanin loading dose regimen, all
patients were divided into four groups. Group A (CLcr≥60mL/min) : Teicoplanin was
intravenously administered 3 times for moderate infections (skin, soft tissue and
respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or
severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by
maintenance dosing 400 mg/d. Group B (40 mL/min≤CLcr<60mL/min) : Teicoplanin was
intravenously administered 3 times at the loading dose of 400 mg at 12h intervals,
followed by maintenance dosing 400 mg/d. Group C (CLcr<40mL/min) : Teicoplanin was
intravenously administered 2 times at the loading dose of 400 mg at 12h intervals,
followed by maintenance dosing 200 mg/d. Group D (standard regimen) : Teicoplanin was
intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals,
followed by maintenance dosing 200 mg/d. The maintenance dosing was adjusted by Cmin and
CLcr in all groups. The target Cmin was set to 15~30 mg/L. If Cmin<15 mg/L or >30 mg/L,
the maintenance dosage was increased or decreased appropriately up to target Cmin range.
CLcr values for male and female were calculated based on the following equations,
respectively.
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