"Investigation of Caspofungin Plasma Concentration and Pharmacokinetic for the Improvement of the Antifungal Therapy in Patients of Surgical Intensive Care Unit" - CASPO-PK-Intensiv

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001146-13-DE

Enrollment

Registered

2006-03-31

Start date

2006-05-18

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

hospitalised patients

Interventions

Trade Name: Cancidas 50 mg Product Name: Cancidas 50 mg Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Caspofungin Diacetat CAS Number: 179463-17-3 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > 18 years Patients of intensive care unit with proven or probable invasive fungal infections caused by candida or aspergillus species who are treated with Caspofungin as a regular treatment during hospitalisation. Precautions, special warnings, interactions containing in the "Fachinformation" (SPC) have to be followed. Decision for dosage and dose adjustment because of insufficient activity, adverse effect, interactions, organ dysfunctions or body weight should only be made after benefit-risk-estimation. concomitant application of Ciclosporin A, Tacrolimus or Rifampicin and close monitoring of drug levels and liver functions. Voluntarily signed informed consent after full explanation of the study to the patients. 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: Kinetic: Hypersensitivity against Caspofunginacetate or other constituents Patients with severe liver dysfunction concomitant application of Ciclosporin A, Tacrolimus or Rifampicin without close monitoring of drug levels and liver functions. Patients who get Caspofungin less than 10 days. women In case of contraindications containing in the "Fachinformation" (SPC).

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of the plasma concentration and the pharmakokinetic variables of patients of intensive care unit to improve the antifungal therapy.;Secondary Objective: Influence of organ dysfunctions and diseases on the plasma concentration and the pharmakokinetic of patients of intensive care unit.;Primary end point(s): Trough concentration (Ctrough), peak concentration (Cpeak) Area under the plasma concentration time curve (AUCtotal) maximal plasma concentrations (Cmax), time of Cmax	—

Measure

Time frame

Main Objective: Determination of the plasma concentration and the pharmakokinetic variables of patients of intensive care unit to improve the antifungal therapy.;Secondary Objective: Influence of organ dysfunctions and diseases on the plasma concentration and the pharmakokinetic of patients of intensive care unit.;Primary end point(s): Trough concentration (Ctrough), peak concentration (Cpeak) Area under the plasma concentration time curve (AUCtotal) maximal plasma concentrations (Cmax), time of Cmax

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Countries

Germany

Outcome results

None listed

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