Study of Tigecycline Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy(CRRT)

Critically Ill Clinical Trial

Official title:

Pharmacokinetics of Tigecycline in Critical Ill Patients Undergoing Continuous Renal Replacement Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02931526
• Other study ID #: LCYJ1
• Status: Recruiting
• Phase: N/A
• First received: September 19, 2016
• Last updated: October 10, 2016
• Start date: August 2016

Study information

• Verified date: July 2016
• Source: Zhujiang Hospital
• Contact: Wang Liqing, Doctor
• Phone: +86-02061643555
• Email: wliqing2014[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and examine whether the dosage needs adjustment.

The study will observe two groups of patients respectively and compare the difference between them. Patients who need to receive CRRT when treat with high-dose tigecycline will be collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected in Group non-CRRT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged 18-75 years,hospitalized ICU patients, male or female;

• having definitive diagnosis to treat with tigecycline for bacterial infection;

• receiving CRRT with renal insufficiency or not receiving CRRT with normal renal function.

Exclusion Criteria:

• Patients with Child-Pugh C cirrhosis;

• Allergic to tetracycline or tigecycline;

• Patients received CRRT for < 3 days or treated with tigecycline < 3 days;

• Patients who are pregnant.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Critical Illness
• Critically Ill

Intervention

Drug:
• Tigecycline
Patients who have the definitive diagnosis to treat with tigecycline for bacterial infection will be started on tigecycline with a loading dose 200mg IV followed by 100mg IV every 12h.

Locations

Country	Name	City	State
China	Zhujiang Hospital,Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tigecycline Steady State Plasma Concentrations	Steady State Plasma Concentration(Css) in blood	Day 1-3	Yes
Secondary	Peak Plasma Concentration(Cmax) of Tigecycline in blood		Day 1-3	Yes
Secondary	Trough Plasma Concentration(Cmin) of Tigecycline in blood		Day 1-3	Yes
Secondary	Area Under the Plasma Concentration versus Time Curve(AUC)		Day 1-3	Yes
Secondary	Minimal Inhibitory Concentration(MIC)		Day 1-3	Yes