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Measurement of antabiotic concentration i subcutis and blood in patients receiving ECMO treatment

Concentration of Meropenem in Plasma and Subcutis in Patients on ECMO Treatment - CONECT

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-000218-23-DK
Enrollment
Unknown
Registered
2015-03-03
Start date
2015-03-26
Completion date
Unknown
Last updated
2016-10-31

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

Conditions

Infections related to ECMO-hospitalisation MedDRA version: 17.1 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Meropenem Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: MEROPENEM CAS Number: 96036-03-2 Other descriptive name: MEROPENEM Concentr

Sponsors

Aarhus University Hospital, Skejby
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Signed informed consent - Age = 18 - In treatment with meropenem - Ongoing ECMO-treatment, =65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: - Allergy to meropenem - pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: The objective og this trial is to asses the penetration og meropenem into subcutis using the pharmacokinetic tool microdialysis. The primary endpoint is the time above the minimal inhibitory concentration (T>MIC). Secondary endpoints are standard pharmacokinetic parameters.;Secondary Objective: Not applicable;Primary end point(s): Time above the minimal inhibitory concentration (T>MIC) during a dosage interval (8 hours) in respectively plasma and subcutis.;Timepoint(s) of evaluation of this end point: At the end of the study

Secondary

MeasureTime frame
Secondary end point(s): Secondary endpoints are standard pharmacokinetic parameters (eg. half-life, Cmax, AUC, Tmax and Vd);Timepoint(s) of evaluation of this end point: At the end of the study

Countries

Denmark

Contacts

Public ContactPelle Hanberg

Aarhus University Hospital

pellehanberg@hotmail.com004528744852

Outcome results

None listed

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