Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group A 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. |
Device: other antibacterial agents，breathing machine
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents. Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
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| Group B 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. |
Device: other antibacterial agents，breathing machine
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents. Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
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| Group C 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. |
Device: other antibacterial agents，breathing machine
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents. Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
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| Group 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. |
Device: other antibacterial agents，breathing machine
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents. Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
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Outcome Measures
Primary Outcome Measures
- Serum teicoplanin trough concentrations [0.5 hour before teicoplanin administration on the fourth day]
Teicoplanin trough samples were taken immediately 30 minutes before teicoplanin administration on the fourth day. Blood samples for 2-3 mL were collected in blood-collection tubes without any additives and centrifuged at 3500 rpm for 10min. Serum teicoplanin trough concentrations (Cmin) were determined by a high-performance liquid chromatography method as previously described. The detections were completed in Translational Medicine Center of Zhengzhou Central Hospital affiliated to Zhengzhou University.
Secondary Outcome Measures
- White blood cell count (WBC) [2 years]
It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
- C-reaction protein (CRP) [2 years]
It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
- Asparttate aminotransferase (AST) [2 years]
It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
- Alanine aminotransferase (ALT) [2 years]
It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
- Serum creatinine (Scr) [2 years]
It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
- CLcr [2 years]
It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age≥18 years
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duration of teicoplanin therapy≥5 days
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written informed consent was obtained from each patients
Exclusion Criteria:
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Patients who were allergy to teicoplanin
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pregnant women
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patients with hematopoietic function
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patients unable to evaluate efficacy and safety
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- People's Hospital of Zhengzhou University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LZhou