Voriconazole versus amphotericin B for empirical antifungal therapy in febrile neutropenia
- Conditions
- Patients with hematologic malignancies who developed chemotherapy-induced neutropenia and fever.Febrile neutropeniaVoriconazoleAmphotericin B DeoxycholateHematologic malignancyEmpirical antifungal therapy
- Registration Number
- TCTR20190717001
- Lead Sponsor
- Faculty of Medicine Siriraj Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 68
1. Adult age more than 18 years old with hematologic malignancy
2. Admit at medicine and hemato-oncological ward
3. Developed febrile neutropenia as definition of IDSA 2010
4. The febrile neutropenia patient who still have fever after received antimicrobial therapy at least 4 days
1. Received empirical antifungal therapy more than 24 hours.
2. Confirm diagnosis of invasive fungal disease
3. Received empirical antifungal therapy such as posaconazole; which level of posaconazole more than 0.7 microgram/ml, or currently take voriconazole.
4. History of voriconazole allergy or amphotericin B deoxycholate allergy
5. Renal insufficiency
6. Liver impairment
7. NPO patient
8. Septic shock or sepsis related hypotension required vasopressor
9. Suspectation of death in 72 hours
10. Pregnancy and lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical efficacy 28 days after treatment Fungal-free survival after treatment
- Secondary Outcome Measures
Name Time Method Adverse drug reaction 28 day after treatment 1. Cr rising, 2. elevated of liver enzyme, 3. no nausea and vomitting,Clinical response On the duration of drug admisnistration time to resolution of fever,Clinical efficacy On the duration of drug admisnistration no evidence of breakthrough fungal infection,Lenght of stay Untill study end Duration of the in - patient admission,Clinical efficacy Untill study end 90-day mortality rate