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Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics

NCT00421187 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-03-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Liposomal amphotericin B (AmBisome®)

DRUG

Liposomal amphotericin B (AmBisome®)

Sponsors & Collaborators

Principal Investigators

  • Lazaros Poughias, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-04-30
Completion
2008-05-31

Countries

  • Greece

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00421187 on ClinicalTrials.gov