CClinicalTrials.gg
Sign In
Status unknownNCT02931526Updated Oct 13, 2016

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

An observational study in Bacterial Infection and Critically Ill, sponsored by Zhujiang Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-13.

Sponsored by Zhujiang Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bacterial Infection
  • Critically Ill

Keywords

  • Tigecycline
  • Continuous Renal Replacement Therapy
  • Pharmacokinetics
03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's planned enrollment of 20 is below the median of 200 across 229 observational studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • 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

  • DrugTigecycline

    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

06

What researchers measure

Primary outcomes

  1. Tigecycline Steady State Plasma Concentrations

    Steady State Plasma Concentration(Css) in blood

    Time frame: Day 1-3

Secondary outcomes

  1. Peak Plasma Concentration(Cmax) of Tigecycline in blood

    Time frame: Day 1-3

  2. Trough Plasma Concentration(Cmin) of Tigecycline in blood

    Time frame: Day 1-3

  3. Area Under the Plasma Concentration versus Time Curve(AUC)

    Time frame: Day 1-3

  4. Minimal Inhibitory Concentration(MIC)

    Time frame: Day 1-3

07

Study locations

1 of 1 sites recruiting
  • Zhujiang Hospital,Southern Medical University
    Guangzhou, Guangdong 510282, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32716292 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02931526
Lead sponsor
Zhujiang Hospital
Responsible party
Sponsor
First posted
Oct 13, 2016
Start date
Aug 2016
Primary completion
Aug 2017 (estimated)
Last update
Oct 13, 2016

Study contacts

Wang Liqing, Doctor
Contact
wliqing2014@163.com
+86-02061643555
Wang Liqing, Doctor
principal investigator · Zhujiang Hospital,Southern Medical Unversity

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Bacterial Infections→

Other studies from this sponsor

Zhujiang Hospital

Start the discussion