Therapeutic Drug Monitoring of Voriconazole

Phase 2

Conditions: Invasive pulmonary aspergillosis.
Invasive pulmonary aspergillosis
B44.0

Registration Number: IRCT20151227025726N19

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	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.

Secondary Outcome Measures

Name	Time	Method
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.