Analysis of relation between itraconazole blood concentration and body clinical dynamics,laboratory test values
- Conditions
- Immunocompromised patients
- Registration Number
- JPRN-UMIN000036201
- Lead Sponsor
- Hamamatsu University School of Medicine Department of Hospital Pharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.)
- Secondary Outcome Measures
Name Time Method