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

Pharmacokinetics of trimethoprim-sulfametrole in critically ill patients on continuous veno-venous haemofiltration

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003403-29-AT

Enrollment

Registered

2014-09-02

Start date

2014-09-26

Completion date

Unknown

Last updated

2020-11-23

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

Conditions

Life-threatening infection treated with trimethoprim-sulfametrole (Rokiprim) in critically ill patients on and off continuous veno-venous haemfiltration

Interventions

Trade Name: Rokiprim Product Name: Rokiprim Pharmaceutical Form: Solution for infusion INN or Proposed INN: SULFAMETROLE CAS Number: 32909-92-5 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Austria

Contacts

Public ContactRomuald Bellmann

Medical University Innsbruck

romuald.bellmann@i-med.ac.at004351250481389

Outcome results

None listed

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