Pharmacokinetics of Tigecycline in Patients Receiving Continuous Renal Replacement Therapy

Phase 1

• Conditions: Surgical ICU patients with severe infection and renal replacement therapy; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-005617-39-DE
• Lead Sponsor: niversity Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-17
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

* Male and female patients
* Indication for Tigecycline therapy based on suspected/diagnosed infection
* Patients with acute renal failure and renal replacement therapy (CVVHD of CVVHDF)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

* Pregnant women
* breastfeeding mother
* Age > 75 years
* liver failure
* Comedication with warfarin
* Known allergies to antibiotics of the tetracycline group

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified