Concentrations of antibiotics in the lung in mechanically ventilated critically ill patients: example meropenem

Determination of the penetration of antibiotics into epithelial lining fluid during continuous infusion in mechanically ventilated ICU patients: example meropenem

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000443-27-DE

Enrollment

Registered

2012-03-19

Start date

2012-06-12

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

pneumonia complicated urinary infection complicated abdominal infection complicated skin and soft tissue infection acute bacterial meningitis MedDRA version: 20.0 Level: LLT Classification code 10049582 Term: Soft tissue infection NOS System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10040874 Term: Skin infection NOS System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10046576 Term: Urinary tract infection, site not specified

Interventions

Trade Name: Meronem 1000 mg Pharmaceutical Form: Powder for infusion INN or Proposed INN: MEROPENEM CAS Number: 96036-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age 18 years or more - mechanical ventilation via a endotracheal tube or cannula - continuous infusion of an IMP prescribed by the attending physician due to suspected or proven infection - informed consent by the patient or the legal representative 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - simultaneous participation in another clinical trial - renal replacement therapy - contraindications against bronchoscopy (e.g. coagulopathy, extremely compromised pulmonary gas exchange) - hypersensitivity to meropenem or to other carbapenems - severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to other betalactam antibiotics (e.g. penicillins, cephalosporins)

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of penetration of IMPs into the epithelial lining fluid in intensive care unit patients;Secondary Objective: Exploratory analysis of patient specific characteristics as covariates of IMP penetration into epithelial lining fluid;Primary end point(s): Concentration of the IMPs in plasma and epithelial lining fluid, determination of the penetration.;Timepoint(s) of evaluation of this end point: 20 patients evaluable	—

Measure

Time frame

Main Objective: Determination of penetration of IMPs into the epithelial lining fluid in intensive care unit patients;Secondary Objective: Exploratory analysis of patient specific characteristics as covariates of IMP penetration into epithelial lining fluid;Primary end point(s): Concentration of the IMPs in plasma and epithelial lining fluid, determination of the penetration.;Timepoint(s) of evaluation of this end point: 20 patients evaluable

—

Secondary

Measure	Time frame
Secondary end point(s): correlation of the penetration of the IMPs into epithelial lining fluid with routine patient characteristics (e.g. age, weight, height, renal function markers, underlying disease);Timepoint(s) of evaluation of this end point: 20 patients evaluable	—

Countries

Germany

Contacts

Public Contacthead office

Dept. of Anesthesiology and Intensive Care, Charité - Campus Benjamin Franklin

martin.kees@charite.de00493084452731

Outcome results

None listed

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