Pharmacokinetics of Tigecycline in Patients Receiving Continuous Renal Replacement Therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005617-39-DE

Enrollment

Registered

2013-12-17

Start date

2014-01-14

Completion date

Unknown

Last updated

2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical ICU patients with severe infection and renal replacement therapy

Interventions

Trade Name: Tygacil Product Name: Tygacil Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: TIGECYCLINE CAS Number: 220620-09-7 Concentration unit: mg milligram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Blood concentration 0, 1 h, 1,25 h, 1,5h, 1,75 h, 2 h, 4 h, 6 h, 8 h und 12 h after start of Tigecyclin-infusion during renal replacment therapy;Main Objective: The aim of the present study is to assess the pharmacokinetics of tigecycline in patients with acute renal failure receiving continuous veno-venous hemodialysis (CVVHD) with regional citrate anticoagulation or continuous veno-venous hemodiafiltration (CVVHDF) with conventional heparin-based anticoagulation. Particularly, the following parameters should be evaluated: •Area under the concentration-time curve from 0 to 12 h (AUC0-12) in 8 patients each receiving CVVHD (citrate anticoagulation) or CVVHDF (heparin anticoagulation and predilution), respectively. •Comparison of these AUC0-12 data with the values described in previous population kinetics. •Total elimination half-life of tigecycline under CVVHD and CVVHD All measurements will be taken under steady state conditions (on day 4 or later of intra-venous tigecycline treatment with an initial single dose of 100 mg iv and 50 mg iv b.i.d) after starting CVVHD or CVVHDF for at least 24 hours. ;Secondary Objective: Not applicable;Primary end point(s): AUC of tigecycline during renal replacement therapy in comparison to published pharamkokinetic data in healthy adults	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Blood concentration 0, 1 h, 1,25 h, 1,5h, 1,75 h, 2 h, 4 h, 6 h, 8 h und 12 h after start of Tigecyclin-infusion during renal replacment therapy;Main Objective: The aim of the present study is to assess the pharmacokinetics of tigecycline in patients with acute renal failure receiving continuous veno-venous hemodialysis (CVVHD) with regional citrate anticoagulation or continuous veno-venous hemodiafiltration (CVVHDF) with conventional heparin-based anticoagulation. Particularly, the following parameters should be evaluated: •Area under the concentration-time curve from 0 to 12 h (AUC0-12) in 8 patients each receiving CVVHD (citrate anticoagulation) or CVVHDF (heparin anticoagulation and predilution), respectively. •Comparison of these AUC0-12 data with the values described in previous population kinetics. •Total elimination half-life of tigecycline under CVVHD and CVVHD All measurements will be taken under steady state conditions (on day 4 or later of intra-venous tigecycline treatment with an initial single dose of 100 mg iv and 50 mg iv b.i.d) after starting CVVHD or CVVHDF for at least 24 hours. ;Secondary Objective: Not applicable;Primary end point(s): AUC of tigecycline during renal replacement therapy in comparison to published pharamkokinetic data in healthy adults

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Germany

Contacts

Public ContactDept of Anestheseiology

University Hospital Tuebingen

4970712986900

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026