Determination of antibiotic concentrations in interstitial space fluid of muscle and subcutis in septic patients including a pilot phase

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012985

Enrollment

Registered

2018-12-20

Start date

2014-06-21

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

A41.8

Interventions

Group 1: Determination of pharmacokinetics of moxifloxacin in interstitial space fluid of muscle and subcutis by microdialysis in septic patients

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >= 18 years, severe sepsis or septic shock as diagnosed according to the criteria of ACCP/SCCM within 24 hours

Exclusion criteria

Exclusion criteria: Age < 18 years

Design outcomes

Primary

Measure	Time frame
Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2) in the microdialysate and plasma after single dose and at steady state on day 1, 3 and 5	—

Secondary

Measure	Time frame
1) Relationship subject condition and therapeutic measures and pharmacokinetic parameters 2) Protein binding throughout the study 3) AUCtissue/AUCplasma ratio 4) PK/PD parameters: ratio of area under the concentration vs. time curve from 0 to 24 hours (AUC0-24)/MIC; Cmax/MIC 5) Survival (also on days 1, 3 and 5)	—

Countries

Germany

Contacts

Public ContactHartmuth Nowak

Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum Knappschaftskrankenhaus Bochum

hartmuth.nowak@kk-bochum.de0234/299-3001

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 21, 2026