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

Phase 1

• Conditions: pneumoniacomplicated urinary infectioncomplicated abdominal infectioncomplicated skin and soft tissue infectionacute bacterial meningitis; MedDRA version: 20.0Level: LLTClassification code 10049582Term: Soft tissue infection NOSSystem Organ Class: 100000004862; MedDRA version: 20.0Level: LLTClassification code 10040874Term: Skin infection NOSSystem Organ Class: 100000004862; MedDRA version: 20.0Level: LLTClassification code 10046576Term: Urinary tract infection, site not specifiedSystem Organ Class: 100000004862; MedDRA version: 22.1Level: LLTClassification code 10035725Term: Pneumonia NOSSystem Organ Class: 100000004862; MedDRA version: 20.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-000443-27-DE
• Lead Sponsor: Dept. of Anesthesiology and Intensive Care, Charité - Campus Benjamin Franklin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-19
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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