Immunocompromised patients
Conditions
Interventions
None listed
Sponsors
Hamamatsu University School of Medicine Department of Hospital Pharmacy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who is over 20 years old and has been taking at least 14 days after starting taking itraconazole 2) Patients who judged that doctor can participate in this research 3) Patients who was able to obtain consent by signing the consent form by the person himself / herself to participate in this research 4) Patients who gained consent by consent form regarding use of the sample or information for research
Exclusion criteria
Exclusion criteria: exclusion criteria: (1) patients who were being co-treated with a strong inducer or inhibitor of CYPs, including macrolide antibiotics, rifampicin, and carbamazepine (2) patients who were receiving administration of cyclosporin A; (3) patients who were receiving ITZ oral solution except for before bedtime; (4) patients who were being co-treated with more than 1 g per day of sulfamethoxazole (5) patients who had severe bacterial or mycotic infections; (6) patients with hepatic dysfunction (serum total bilirubin > 2.0 mg/dL) before starting ITZ; (7) patients with more than 1.5 mg/dL of serum creatinine before staring ITZ; and (8) patients with poor adherence based on pharmacist interviews and medical records; (9) patients who judged that doctor is inappropriate ; (10) patients who did not obtain consent to participate in this research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The total blood concentration and free form blood concentration (including optical isomers) of ITZ and its metabolites (OH - ITZ, Keto - ITZ, ND - ITZ)2) Free form fraction of ITZ and its metabolites 3) Blood kinetics Parameter fluctuation factors (clinical laboratory values, glycoalbumin, diseases, concomitant medications, inflammatory markers, liver and kidney function markers) Study 1: Relationship between blood concentration and liver function marker (concentration of CYP3A active marker (4B hydroxylated cholesterol in the blood, 25 hydroxylated vitamin D3 in blood, miRNA-24b), drug metabolizing enzymes (CYP3A4, CYP3A5) Genetic polymorphism of drug transport carriers (OATP 1 B 1, OATP 1 B 3, ABCB 1, ABCC 2, ABCG 2, MATE 1, MATE 2), total bilirubin, coproporphyrin etc.) Study 2: Relationship between blood concentration and kidney function marker (creatinine, cystatin C, BUN, etc.) | — |
Countries
Japan
Contacts
Public ContactYumi Imoto
Hamamatsu University School of Medicine Department of Hospital Pharmacy
Outcome results
None listed