Clinical trial NCT03229135: Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia Gram-Positive Bacterial
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The clinical data of 113 patients who were suffered with severe Gram-positive infection and treated with teicoplanin from February 2015 to August 2016 were retrospectively analyzed.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age≥18 years
* duration of teicoplanin therapy≥5 days
* written informed consent was obtained from each patients

Exclusion Criteria:

* Patients who were allergy to teicoplanin
* pregnant women
* patients with hematopoietic function
* patients unable to evaluate efficacy and safety

Primary outcomes:
measure: Serum teicoplanin trough concentrations
timeFrame: 0.5 hour before teicoplanin administration on the fourth day
Secondary outcomes:
measure: White blood cell count (WBC)
timeFrame: 2 years
measure: C-reaction protein (CRP)
timeFrame: 2 years
measure: Asparttate aminotransferase (AST)
timeFrame: 2 years
measure: Alanine aminotransferase (ALT)
timeFrame: 2 years
measure: Serum creatinine (Scr)
timeFrame: 2 years
measure: CLcr
timeFrame: 2 years
Other outcomes:
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