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Daptomycin concentration in drainage fluid and blood samples of ICU patients

Daptomycin concentration in drainage fluid and blood samples of ICU patients - Dapto

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-000125-36-DE
Enrollment
10
Registered
2016-03-21
Start date
2016-08-02
Completion date
Unknown
Last updated
2021-07-26

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

Conditions

Intensive Care Patients after Surgery treated with Daptomycin and wound draingae

Interventions

Trade Name: Cubicin Product Name: Cubicin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: DAPTOMYCIN CAS Number: 103060-53-3 Concentration unit: mg milligram(s) Concentratio

Sponsors

University Hospital Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: * Patients = 18 /=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Schwangerschaft (Ausschluss per routinemäßigem Schwangerschaftstest bei weiblichen Notfallpatientinnen 85 years * documented allergy to daptomycin * acute rhabdomyolysis (increase in Kreatinphosphokinase and Laktatdehydrogenase > fivefold of upper limit: Kreatinphosphokinase >950U/l, Laktatdehydrogenase >1250 U/l) * patients dependent on sponsor, manufactor or principle investigator or their relatives

Design outcomes

Primary

MeasureTime frame
Main Objective: Pharmakokinetics of Daptomycin in intensive care patients with wound drainage after surgery;Secondary Objective: Incidence of gram-positive infection; LOS ICU LOS Hospital;Primary end point(s): Pharmakokinetic of daptomycin in blood; elimination of daptomycin n drainage;Timepoint(s) of evaluation of this end point: Postoperative day 1-3

Secondary

MeasureTime frame
Secondary end point(s): LOS ICU and hospital;Timepoint(s) of evaluation of this end point: Release of ICU and relase of hospital

Countries

Germany

Contacts

Public ContactIntensive Care Unit 39

University Hospital Tübingen

helene.haeberle@med.uni-tuebingen.de+49070712986724

Outcome results

None listed

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