Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients

NCT03034174 | Completed

• 1 other identifier: KE-0254/258/2014
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Septic Shock; Antibiotic Resistant Infection; Critical Illness

Keywords

tigecycline; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Serum concentration of tigecycline

  Samples obtain from ICU patients 2, 4, 8 12 hours after each dose of tigecycline for 3 days.

  72 hours for each patient from the tigecycline treatment initiation.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

II Department of Anesthesia and Intensive Care, Medical University of Lublin

Lublin, 20-081, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients' arterial blood samples.

MeSH Terms

Conditions

Shock, Septic; Critical Illness

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Officials

• Mirosław Czuczwar, M.D. PhD.

  Medical University of Lublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: January 15, 2017
• Primary Completion: December 15, 2017
• Study Completion: October 10, 2018
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)