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Completed

NCT Number: NCT03229135

Loading Regimen,Serum Trough Concentrations,Efficacy and Safety in Pneumonia Patients With Gram-positive Infections

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

other antibacterial agents,breathing machine

Device

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.

Primary outcomes

  1. Serum teicoplanin trough concentrations

    Time frame: 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 outcomes

  1. White blood cell count (WBC)

    Time frame: 2 years

    It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.

  2. C-reaction protein (CRP)

    Time frame: 2 years

    It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.

  3. Asparttate aminotransferase (AST)

    Time frame: 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.

  4. Alanine aminotransferase (ALT)

    Time frame: 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.

  5. Serum creatinine (Scr)

    Time frame: 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.

  6. CLcr

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

People's Hospital of Zhengzhou University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 25, 2017
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.