Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients
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|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
|Condition or disease|
|Septic Shock Antibiotic Resistant Infection Critical Illness|
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.
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|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|
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.
- 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
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
|Contact: Michał A Borys, M.D., PhD.||+email@example.com|
|Contact: Paweł Piwowarczyk, M.D.||+firstname.lastname@example.org|
|II Department of Anesthesia and Intensive Care, Medical University of Lublin||Recruiting|
|Lublin, Poland, 20-081|
|Contact: Michał A Borys, M.D., PhD. +48506350569 email@example.com|
|Contact: Paweł Piwowarczyk, M.D. +48511285352 firstname.lastname@example.org|
|Principal Investigator:||Mirosław Czuczwar, M.D. PhD.||Medical University of Lublin|