Suspected or confirmed Gram-positive infection in patients with haematological malignancy.
Conditions
Interventions
Trade Name: Targocid®
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
Tallaght Hospital, Dublin 24, Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Haematological malignancy; 18 years or above; treated with teicoplanin for at least 3 days; suitable intravenous or intra-arterial access; written informed consent obtained. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Consent not obtained; age <18 years; administered teicoplanin for <3 days; limited or no IV or intra-arterial access; receiving renal replacement therapy; admittance to the Intensive Care Unit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the pharmacokinetic parameters of teicoplanin in adult patients with haematological malignancy.;Secondary Objective: To identify important clinical factors affecting the pharmacokinetics of teicoplanin in patients with haematological malignancy. To compare free versus total teicoplanin concentrations and their correlation with clinical outcome (where available). To explore relationships between pharmacokinetic and pharmacodynamic parameters and clinical outcome (where available). To explore whether current dosages of teicoplanin achieve concentrations associated with positive clinical outcomes (where available). ;Primary end point(s): The primary endpoint is a description of the pharmacokinetic parameters of teicoplanin in adult patients with haematological malignancy, such AUC24, Cl, V and t1/2.;Timepoint(s) of evaluation of this end point: The time points for evaluation of this end point are during teicoplanin therapy and up to 48 hours after therapy is discontinued. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is a relationship between pharmacokinetic and pharmacodynamic parameters, such as AUC24/MIC, and the clinical outcome of therapy (where available).;Timepoint(s) of evaluation of this end point: The time points for evaluation of this end point is during teicoplanin therapy and up to 48 hours after therapy is discontinued. | — |
Countries
Ireland
Contacts
Public ContactTeicoplanin Trial Information
Tallaght Hospital, Dublin 24, Ireland
Outcome results
None listed