Blood concentrations of the antibiotic trimethoprim-sulfametrole in critically ill patients on continuous renal replacement therapy

Phase 1

• Conditions: ife-threatening infection treated with trimethoprim-sulfametrole (Rokiprim) in critically ill patients on and off continuous veno-venous haemfiltration; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-003403-29-AT
• Lead Sponsor: Innsbruck Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-02
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Indication for treatment with TMP-SMT. In patients with renal impairment requiring CVVH, the benefit of TMP-SMT must outweigh the potential nephrotoxicity of TMP-SMT.
Approximately normal renal function (plasma creatinine concentration < 1.5 mg/dl) or renal failure requiring continuous veno-venous haemofiltration (CVVH)
Indication for arterial or venous line
Age above 18 years

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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Age below 18 years
Lacking indication or contraindication for treatment with TMP-SMP
Renal impairment (plasma creatinine = 1.5 mg/dl) not requiring CVVH
Pregnancy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Potential effects of continuous veno-venous haemofiltration on single and multiple dose pharmacokinetics of sulfametrole and trimethoprim will be assessed. ;Secondary Objective: Assessment of haemofilter clearance (CLHF) of TMP and SMT;Primary end point(s): Plasma pharmacokinetics TMP and SMT (peak levels [Cmax], trough levels [Cmin], area under the concentration time curve [AUC], half-live [t1/2], volume of distribution [Vd] and clearance [CL]) on and off haemofiltration;Timepoint(s) of evaluation of this end point: Study day 1 and study day 3 or later

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Haemofilter clearance (CLHF) of TMP and SMT;Timepoint(s) of evaluation of this end point: Study day 1 and study day 3 or later