Plasma concentration-over-time profile of the antibiotic temocillin in urinary tract infection patients with variable degrees of reduced kidney function

Plasma pharmacokinetics of temocillin in urinary tract infection patients with variable degrees of renal impairment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005741-32-BE

Enrollment

100

Registered

2021-12-09

Start date

2022-02-24

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

urinary tract infection, renal impairment

Interventions

Trade Name: Negaban Product Name: Negaban Product Code: BE467724, BE467733 Pharmaceutical Form: INN or Proposed INN: TEMOCILLIN CAS Number: 66148-78-5 Concentration unit: g gram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 years, informed consent, 4 day hospitalization for temocillin treatment of UTI 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Patient age < 18 years, ß-lactams or penicillin allergy, women of childbearing potential, Participation in another clinical study < 30 days before inclusion in the present study

Design outcomes

Primary

Measure	Time frame
Main Objective: Development of a new, PK/PD-optimized temocillin dose reduction scheme for the treatment of urinary tract infection in patients with renal impairment based on renal function;Secondary Objective: Compare and analyze treatment outcomes in individual patients based on PK/PD parameters;Primary end point(s): plasma samples after administration 4th dose of temocillin ;Timepoint(s) of evaluation of this end point: 0, 0.5, 1, 3, 4, 6, 8, 12, 24, 48 hours (final time-point depends on selected dose in dose reduction scheme based on renal function, e.g. 24h for 2g q24h regimen)	—

Measure

Time frame

Main Objective: Development of a new, PK/PD-optimized temocillin dose reduction scheme for the treatment of urinary tract infection in patients with renal impairment based on renal function;Secondary Objective: Compare and analyze treatment outcomes in individual patients based on PK/PD parameters;Primary end point(s): plasma samples after administration 4th dose of temocillin ;Timepoint(s) of evaluation of this end point: 0, 0.5, 1, 3, 4, 6, 8, 12, 24, 48 hours (final time-point depends on selected dose in dose reduction scheme based on renal function, e.g. 24h for 2g q24h regimen)

—

Secondary

Measure	Time frame
Secondary end point(s): minimal inhibitory concentration (MIC);Timepoint(s) of evaluation of this end point: at presentation, after treatment (if the causative pathogen was not eradicated by temocillin treatment)	—

Countries

Belgium

Contacts

Public ContactGuichet académique UCLouvain/CTC

UCLouvain

guichetacademiqueuclouvain-saintluc@uclouvain.be

Outcome results

None listed

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