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

NCT02931526 | Unknown DMC

• 1 other identifier: LCYJ1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Infection; Critically Ill

Keywords

Tigecycline; Continuous Renal Replacement Therapy; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Tigecycline Steady State Plasma Concentrations

  Steady State Plasma Concentration(Css) in blood

  Day 1-3

Secondary Outcomes (4)

• Peak Plasma Concentration(Cmax) of Tigecycline in blood

  Day 1-3

• Trough Plasma Concentration(Cmin) of Tigecycline in blood

  Day 1-3

• Area Under the Plasma Concentration versus Time Curve(AUC)

  Day 1-3

• Minimal Inhibitory Concentration(MIC)

  Day 1-3

Study Arms (2)

Group CRRT

Patients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT

Drug: Tigecycline

Group non-CRRT

Patients who need to treat with tigecycline for bacterial infection, have normal renal function in ICU and have no need to treat with CRRT

Drug: Tigecycline

Interventions

Tigecycline DRUG

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.

Also known as: Tygacil

Group CRRT; Group non-CRRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized Intensive Care Unit(ICU) patients in Zhujiang Hospital, in need of treatment with antiinfectives

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

Related Publications (1)

• Zhao HH, Tang WJ, Yang YX, Cen ZR, Wang LQ. PK/PD study of tigecycline in severely infected patients with continuous renal replacement therapy. Int J Clin Pharmacol Ther. 2020 Oct;58(10):531-538. doi: 10.5414/CP203669.

  PMID: 32716292 DERIVED

Biospecimen

Retention: NONE RETAINED

Whole blood, serum, urine, effluent fluid from dialysis machine

MeSH Terms

Conditions

Bacterial Infections; Critical Illness

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Wang Liqing, Doctor

  Zhujiang Hospital,Southern Medical Unversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Liqing, Doctor

CONTACT

+86-02061643555; wliqing2014@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: October 13, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Last Updated: October 13, 2016

Record last verified: 2016-07

Locations

CN (1)