Status:
TERMINATED
Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics
Lead Sponsor:
Gilead Sciences
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Administration of a single high dose (10 mg/kg) of AmBisome® no later than 72 hours after ARNF onset followed by two 5 mg/kg doses on days 2 and 5 may provide sustained tissue levels of amphotericin B...
Detailed Description
This is a phase III, multicenter, randomized, open-label study. One center in the United Arab Emirates and 1 center in Turkey will participate in this trial and approximately 50 patients will be recru...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. Adult patients with hematologic malignancy undergoing chemotherapy for leukemia or lymphoma will be recruited into this study from 2 centers provided the following inclusion criteria are fulfilled:
- Male or female
- Age ≥ 18 years
- Neutropenia (\< 0.5 x 109 cells/L)
- Received empiric antibiotic treatment for 3 days for blood culture negative infection
- Persistent fever of ≥ 38°C
- No known IFI at baseline during this neutropenic episode. However, patients with "missed" evidence of IFI (features absent at randomization but evidence within 48 hours \[eg, positive chest computerized tomography (CT)\]) will complete the randomized treatment and kinetic measurements
- No antifungal prophylaxis or treatment in this hospital admission or for the past 30 days
- Baseline liver function tests ≤ 10 times the upper limit of normal and baseline creatinine ≤ 2 times the upper limit of normal
- No known hypersensitivity to amphotericin B or LAMB or any of its constituents, in particular known history of anaphylactic reaction to amphotericin B or LAMB or any of its constituents
- Females of childbearing potential (less than 2 years post menopausal) must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline
- Ability to comply with all study requirements
- Written informed consent
Exclusion
- Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- Evidence of proven, probably or possible invasive fungal infection
- Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for \>4 weeks preceding entry into study
- Prior systemic therapy greater or equal to 4 days with any polyene anti-fungal agent within 30 days of study enrollment
- Prior systemic therapy with non-polyenes (i.e., azole or echinochandin derivatives) for the current ARNF. (Prior systemic anti-fungal therapy with non-polyene derivatives for prophylaxis or as empiric therapy for febrile neutropenia is permissible.)
- Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug.
- Serum creatinine \> 2x upper limit of normal (ULN)
- Serum ALT or AST \> 5x ULN
- History of allergy or serious adverse reaction to any polyene anti-fungal agent.
- Patients who have a positive blood culture within 5 days before day 0 with a clinically significant organism isolated from the peripheral blood, who despite appropriate antibiotics have persistent positive cultures
- Pregnant or lactating women.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00421187
Start Date
March 1 2007
End Date
May 1 2008
Last Update
March 11 2011
Active Locations (1)
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1
Gilead Sciences
Athens, Greece, 167 77