Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03034174
Recruitment Status : Unknown
Verified May 2017 by Michał Borys, Medical University of Lublin.
Recruitment status was:  Recruiting
First Posted : January 27, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Michał Borys, Medical University of Lublin

Brief Summary:
The objective of this study is to describe the pharmacokinetics of tigecycline in critically ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200 mg loading dose and 100 mg/12h).

Condition or disease
Septic Shock Antibiotic Resistant Infection Critical Illness

Detailed Description:

This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: tigecycline (200 mg every 12 hours intravenously), meropenem (2 grams every 8 hours intravenously).

Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline for 3 consecutive days. The standard arterial canula will be used to obtain samples.

In each case CVVHD will be started and continued for at least 3 days' period. 30 minutes after a collection each sample will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum tigecycline concentration will be measured with high performance liquid chromatography.

Each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients: an Observational, Prospective Study
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tigecycline

Group/Cohort
tigecycline

Each patient will receive: tigecycline (200 mg q 12 hours i.v.), meropenem (2 g q 8 hours i.v). In each case CVVHD will be started.

Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline for 3 consecutive days.




Primary Outcome Measures :
  1. Serum concentration of tigecycline [ Time Frame: 72 hours for each patient from the tigecycline treatment initiation. ]
    Samples obtain from ICU patients 2, 4, 8 12 hours after each dose of tigecycline for 3 days.


Biospecimen Retention:   Samples With DNA
Patients' arterial blood samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to ICU due to severer sepsis recognition. Both medical and surgical patients will be included. Any site of infection will be treated in the manner.

In each case CVVHD will be initiated and continued. Each patient will receive 200 mg tigecycline q 12h, 2 g meropenem q 8 h. Other treatment as required.

Criteria

Inclusion Criteria:

  • Patients who require ICU treatment due to severe sepsis
  • age 18-80 years
  • CVVHD treatment
  • an eligible consent obtained from the patient or his/her attendant

Exclusion Criteria:

  • allergy to tigecycline or meropenem
  • contraindication to CVVHD
  • lack of consent to participate in the study
  • age of patients below 18 or above 80 years

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): NCT03034174


Contacts
Layout table for location contacts
Contact: Michał A Borys, M.D., PhD. +48506350569 michalborys1@gmail.com
Contact: Paweł Piwowarczyk, M.D. +48511285352 piwowarczyk.pawel@gmail.com

Locations
Layout table for location information
Poland
II Department of Anesthesia and Intensive Care, Medical University of Lublin Recruiting
Lublin, Poland, 20-081
Contact: Michał A Borys, M.D., PhD.    +48506350569    michalborys1@gmail.com   
Contact: Paweł Piwowarczyk, M.D.    +48511285352    piwowarczyk.pawel@gmail.com   
Sponsors and Collaborators
Medical University of Lublin
Investigators
Layout table for investigator information
Principal Investigator: Mirosław Czuczwar, M.D. PhD. Medical University of Lublin

Layout table for additonal information
Responsible Party: Michał Borys, associate professor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03034174     History of Changes
Other Study ID Numbers: KE-0254/258/2014
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michał Borys, Medical University of Lublin:
tigecycline
pharmacokinetics

Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Shock, Septic
Disease Attributes
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Shock
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action