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

NCT03229135 | Completed DMC FDA Device

• 1 other identifier: LZhou
• Study Type: observational
• Target: 113
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia Gram-Positive Bacterial

Outcome Measures

Primary Outcomes (1)

• Serum teicoplanin trough concentrations

  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.

  0.5 hour before teicoplanin administration on the fourth day

Secondary Outcomes (6)

• White blood cell count (WBC)

  2 years

• C-reaction protein (CRP)

  2 years

• Asparttate aminotransferase (AST)

  2 years

• Alanine aminotransferase (ALT)

  2 years

• Serum creatinine (Scr)

  2 years

Study Arms (4)

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

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

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

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

Interventions

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.

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• People's Hospital of Zhengzhou University: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 25, 2017
• Study Start: February 1, 2015
• Primary Completion: August 20, 2016
• Study Completion: October 30, 2016
• Last Updated: July 25, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share