Invasive pulmonary aspergillosis. Invasive pulmonary aspergillosis
Conditions
Interventions
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 u
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSahar Yousefian
Shahid Beheshti University of Medical Sciences
Outcome results
None listed