Comparison of the concentrations of the antibiotic compound Daptomycin in serum, cartilage-, muscle and subcutaneous tissue after a preoperative intravenous administration (Klinische Studie zum Vergleich von Serum – und Gewebekonzentrationen in Subkutis, Muskel, Knorpel und Knochen des Antibiotikums Daptomycin nach präoperativer, intravenöser Applikation zur Infektionsprophylaxe bei orthopädischen Eingriffen) - Daptomycin-Concentration study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004990-24-DE

Enrollment

Registered

2007-12-20

Start date

2008-05-05

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Elective orthopedic surgery MedDRA version: 9.1 Level: PT Classification code 10042609 Term: Surgery

Interventions

Trade Name: Cubicin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: DAPTOMYCIN CAS Number: 103060533 Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Only patients which are planed for elektive surgery and who would in any case receive an antibiotic prophylaxis as a standard procedure - age 18 y and older -- Legally competent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -- Legally incompetent - Parallel participation in another interventional study which could interfere with this clinical trial and/or participation in another clinical study within the last 4 weeks - Infection prior to the surgery - Current treatment with antibiotics - Known or current abuse of drugs or alcohol - Person who is in a dependent relationship with the physician or may consent under duress -Patients with a total body weight of less than 55 kg Contraindications according to the SmPC: - Impaired renal function - Impaired liver function - Drugs with expected interference to the IMP (according to SmPC) Women: - Current or planned pregnancy; lactating patients - Women who do not use one of the following contraceptive methods: - condoms for women, diaphragm or loop each in combination with spermicids or - intrauterine device or - hormonal contraception in combination with a mechanic contraceptive method

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of the concentrations of Daptomycin in serum and tissue (cartilage, subcutaneous tissue, muscle) at different time intervals between 1 to 4 hours after the intravenous preoperative administration ;Secondary Objective: Effectiveness and tolerability (safety) of the prevention of infections by surveillance and documentation of the postoperative clinical course ;Primary end point(s): The concentrations of Daptomycin post surgery in serum and tissue determined by HPLC analysis, then plotted and evaluated in a descriptive manner.	—

Measure

Time frame

Main Objective: Comparison of the concentrations of Daptomycin in serum and tissue (cartilage, subcutaneous tissue, muscle) at different time intervals between 1 to 4 hours after the intravenous preoperative administration ;Secondary Objective: Effectiveness and tolerability (safety) of the prevention of infections by surveillance and documentation of the postoperative clinical course ;Primary end point(s): The concentrations of Daptomycin post surgery in serum and tissue determined by HPLC analysis, then plotted and evaluated in a descriptive manner.

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Countries

Germany

Outcome results

None listed

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