Temocillin use in intensive care units: A Pharmacokinetic study of 6g per day in conventional administration vs. continuous infusion

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003223-20-BE

Enrollment

Registered

2007-07-06

Start date

2007-08-01

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Patients will be eligible for participation in the study if they : 1. are hospitalized in an intensive care unit 2. have an abdominal or a pulmonary infection MedDRA version: 9.1 Level: PT Classification code 10056519 Term: Abdominal infection MedDRA version: 9.1 Level: LLT Classification code 10052110 Term: Bronchopulmonary infection

Interventions

Trade Name: Negaban Pharmaceutical Form: Powder for injection* INN or Proposed INN: TEMOCILLIN CAS Number: 66148785 Concentration unit: g gram(s) Concentration type: range Concentration number: 1-2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients will be eligible for participation in the study if they : 1. are hospitalized in an intensive care unit 2. have an abdominal or a pulmonary infection 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients will not be eligible to participate in the study if they: 1. are confirmed or suspected infected by a bacteria non-susceptible to Temocillin 2. are allergic to Temocillin or any other penicillin 3. are pregnant women or lactating 4. have participated in an investigational drug study within 4 weeks

Design outcomes

Primary

Measure	Time frame
Main Objective: This study is therefore aimed at determining the pharmacokinetic parameters of temocillin in ICU patients receiving 6g per day by continuous infusion (6g/24h) compared to conventional administration (3×2g). These parameters will be measured in the serum and in different body fluids. In parallel, we will monitor the safety and clinical efficacy of this dosing regimen.;Secondary Objective: ;Primary end point(s): To determin the pharmacokinetic parameters of temocillin in ICU patients receiving 6g per day by continuous infusion (6g/24h) compared to conventional administration (3×2g).	—

Measure

Time frame

Main Objective: This study is therefore aimed at determining the pharmacokinetic parameters of temocillin in ICU patients receiving 6g per day by continuous infusion (6g/24h) compared to conventional administration (3×2g). These parameters will be measured in the serum and in different body fluids. In parallel, we will monitor the safety and clinical efficacy of this dosing regimen.;Secondary Objective: ;Primary end point(s): To determin the pharmacokinetic parameters of temocillin in ICU patients receiving 6g per day by continuous infusion (6g/24h) compared to conventional administration (3×2g).

—

Countries

Belgium

Outcome results

None listed

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