Critically ill patients with systemic fungal infection.
Conditions
Interventions
Trade Name: Abelcet 5 mg/ml Concentrate for Suspension for Infusion
Pharmaceutical Form:
Trade Name: AmBisome 50 mg lyophilisate for solution for infusion
Pharmaceutical Form: Powder for solution f
Sponsors
Intensive Care Unit, The Adelaide and Meath Hospital Incorporating the National Children's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients admitted to the ICU and who are in receipt of Abelcet or Ambisome as part of their ICU treatment. Patients over 18 years old 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: Patient under 18 years old, patient/relative refusal, analyst (research investigator) refusal on the basis of patient carrying known serious infectious disease e.g. Hepatitis B or HIV. Children under 16 Adults with learning disabilities Adults who have a terminal illness Those who could be considered to be vulnerable or have a particularly dependent relationship with the investigator, e.g. medical students Women of child bearing age will be included, all will have a pregnancy test and pregnant women will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate pharmacokinetic parameters of Amphotericin B in critically ill patients undergoing continuous veno-venous haemodiafiltration (CVVHDF) and identify any difference between pharmacokinetic parameters in patients on CVVHDF and not on CVVHDF.;Secondary Objective: ;Primary end point(s): Determination of Vd and Cl from the AUC and Cmax of Amphotericin B, as either Abelcet or Ambisome, in critically ill patients. These values are to be determined from the measured Amphotericin B concentrations in the blood samples taken for the purpose of the study. Evaluation of this pharmacokinetic data to determine whether the CVVHDF, as used in the study population, affects these parameters. | — |
Countries
Ireland
Outcome results
None listed