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IRCT20151227025726N19 IRCT 2020-06-16 Shahid Beheshti University of Medical Sciences Therapeutic Drug Monitoring of Voriconazole Determination of Voriconazole Plasma Concentration by HPLC Technique and Evaluating Its Association with Clinical Outcome and Adverse Effects in Patients with Invasive Aspergillosis 2017-12-21 anticipated 24 Complete https://irct.ir/trial/48068 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Invasive pulmonary aspergillosis. Intervention group: Voriconazole was administered as a loading dose of 6 mg per Kg two times daily and maintenance dose of 4 mg per Kg two times daily. For each patient, plasma sample were collected under steady-state condition and analyzed using a validated high performance liquid chromatography method.. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six months after results publishing To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. Farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran How to obtain: Official letter to the researchers Comments:
public Sahar Yousefian
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
Tehran Iran (Islamic Republic of) 6153- 14155 +98 21 8820 0118 saahar26@yahoo.com Shahid Beheshti University of Medical Sciences scientific Farzaneh Dastan
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
Tehran Iran (Islamic Republic of) 6153- 14155 +98 21 8820 0118 fzh.dastan@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with the age of 18 years and older Patients who were initiated on oral or intravenous voriconazole for proven, probable, or possible invasive aspergillosis 18 years no limit Both History of allergy or severe reaction to azoles Aspergilloma or allergic bronchopulmonary aspergillosis Concomitant use of carbamazepine, efavirenz, rifampin, sirolimus or Ergot alkaloids Chronic invasive aspergillosis with duration of symptoms for more than 4 weeks Severe liver dysfunction (total bilirubin, , alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) more than 3 times the upper limit of normal) Receiving combination of antifungal therapy B44.0 Invasive pulmonary aspergillosis Treatment - Drugs Intervention group: Voriconazole was administered as a loading dose of 6 mg per Kg two times daily and maintenance dose of 4 mg per Kg two times daily. For each patient, plasma sample were collected under steady-state condition and analyzed using a validated high performance liquid chromatography method. Voriconazole plasma level. Timepoint: Minimum three days after voriconazole administration (at the time of steady-state). Method of measurement: High performance liquid chromatography. Evaluation of treatment success. Timepoint: 7 and 14 days after treatment and at end of the study. Method of measurement: The evaluation of treatment as partial or complete success was based on clinical (fever, signs and symptoms of infection, and inflammatory markers) and radiological (CT or MRI findings) improvement or eradication of the fungal pathogen. Evaluation of treatment failure. Timepoint: 7 and 14 days after treatment and at end of the study. Method of measurement: Failure to treatment was defined by persistent fungal infection after more than 14 days of treatment or by progressing fungal infection defined by clinical and radiological progression, persistently positive culture results, or death due to fungal infection after more than 7 days of treatment. Adverse drug reaction. Timepoint: Daily. Method of measurement: Observation and lab tests evaluation. Death. Timepoint: At end of the study. Method of measurement: Medical Record. Shahid Beheshti University of Medical Sciences Approved 2017-12-04 Ethics committee of School of Pharmacy, Nursing, and Midwifery; Shahid Beheshti University of Medica No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran Tehran Tehran Iran (Islamic Republic of)