Pharmacokinetics of ertapenem in patients with severe sepsis and intraabdominal infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015948-42-EE

Enrollment

Registered

2009-10-07

Start date

2009-10-28

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Severe sepsis caused by intraabdominal infection either peritonitis or pancreatitis

Interventions

Trade Name: Invanz Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: ERTAPENEM CAS Number: 153832-46-3 Current Sponsor code: 179 Other descriptive name: Invanz

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: adult aged 18-65 years severe sepsis, according to international criteria peritonitis and/or severe pancreatitis 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: renal dysfunction, defined as creatinine clearance less than 30 ml/min calculated using Cockroft-Gault formula morbidly obese patients with BMI over 35 kg/m2

Design outcomes

Primary

Measure	Time frame
Main Objective: To study penetration of ertapenem into abdominal cavity during severe sepsis caused by intrabdominal infection;Secondary Objective: To relate measured intraabdominal concentration to pharmacodynamic measure of antimicrobial efficiency: time over MIC.;Primary end point(s): concentration of ertapenem in abdominal cavity	—

Countries

Estonia

Outcome results

None listed

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