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

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ClinicalTrials.gov Identifier: NCT02931526
Recruitment Status : Unknown
Verified July 2016 by Zhujiang Hospital.
Recruitment status was:  Recruiting
First Posted : October 13, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

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.


Condition or disease Intervention/treatment
Bacterial Infection Critically Ill Drug: Tigecycline

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pharmacokinetics of Tigecycline in Critical Ill Patients Undergoing Continuous Renal Replacement Therapy
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tigecycline

Group/Cohort Intervention/treatment
Group CRRT
Patients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT
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.
Other Name: Tygacil

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
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.
Other Name: Tygacil




Primary Outcome Measures :
  1. Tigecycline Steady State Plasma Concentrations [ Time Frame: Day 1-3 ]
    Steady State Plasma Concentration(Css) in blood


Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   None Retained
Whole blood, serum, urine, effluent fluid from dialysis machine


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931526


Contacts
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Contact: Wang Liqing, Doctor +86-02061643555 wliqing2014@163.com

Locations
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China, Guangdong
Zhujiang Hospital,Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Wang Liqing, doctor    +86-02061643555    wliqing2014@163.com   
Sponsors and Collaborators
Zhujiang Hospital
Investigators
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Principal Investigator: Wang Liqing, Doctor Zhujiang Hospital,Southern Medical Unversity

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Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT02931526     History of Changes
Other Study ID Numbers: LCYJ1
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: July 2016

Keywords provided by Zhujiang Hospital:
Tigecycline
Continuous Renal Replacement Therapy
Pharmacokinetics

Additional relevant MeSH terms:
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Critical Illness
Bacterial Infections
Disease Attributes
Pathologic Processes
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action