Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics
Status:
Terminated
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
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 that are as mycologically effective as those provided after administering
the standard daily dose of 3 mg/kg/day. The new dosing regimen is anticipated to be equally
clinically effective compared with the standard AmBisome® regimen when given for the duration
of neutropenic fever in patients with ARNF. In addition, the degree and incidence of
nephrotoxicity are predicted to be lower with the 3 sequential dose regimen compared to daily
dosing with 3 mg/kg because of the lower cumulative dosage (20 mg/kg versus 42 mg/kg,
respectively), which is 1 contributing factor for the development of acute renal failure.
Furthermore, the lower cumulative dose may be a cost-effective strategy for the treatment of
patients with ARNF.
Phase:
Phase 4
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Amphotericin B Anti-Bacterial Agents Antibiotics, Antitubercular Liposomal amphotericin B