Voriconazole versus amphotericin B for empirical antifungal therapy in febrile neutropenia

Efficacy of voriconazole versus amphotericin B deoxycholate for empirical antifungal therapy in hematologic malignancy patients with febrile neutropenia: A randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190717001

Enrollment

Registered

2019-07-17

Start date

2019-07-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hematologic malignancies who developed chemotherapy&#45

Interventions

Voriconazole is given in normal dose. Other supportive cares are given according to on primary physicians.,Amphotericin B deoxycholate is given in normal dose. Other supportive cares are given accordi

Experimental Drug,Active Comparator Drug

Voriconazole,Amphotericin B deoxycholate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Clinical efficacy 28 days after treatment Fungal-free survival after treatment	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactMethee Chayakulkeeree

Faculty of Medicine Siriraj Hospital

methee.cha@mahidol.ac.th+66850632416

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026