Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.

Infections During Organ Replacement Therapy Clinical Trial

Official title:

Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018939
• Other study ID #: DORIPENEM IN CVVH, MARS AND HD
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2013
• Last updated: March 27, 2014
• Start date: March 2010
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Suspected or proven bacterial infection requiring parenteral antibiotic therapy.

• Organ replacement therapy (MARS, CVVHDF or HD)

Exclusion Criteria:

• Known hypersensitivity to doripenem or other carbapenems, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.

• An expected survival of less than two days.

• Known pregnancy

• Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study

• Doripenem as monotherapy for resistent species or fungal infections.

• Other reasons opposing the study participation on the discretion of the investigators.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infections During Organ Replacement Therapy

Intervention

Other:
• Pharmacokinetic profiling
Pharmacokinetic samples are taken from each Patient receiving Doripenem in each arm. No other interventions are performed during this trial. Doripenem is not administered due to the trial.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of organ replacement therapy on area under curve of doripenem serum concentration	Pharmacokinetic samples are drawn from each patient during the trial. Analysis by HPLC will be conducted after the end of the trial.	day 15	No