Log in
Enquire now
‌

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

OverviewStructured DataIssuesContributors

Contents

clinicaltrials.gov/study/NCT00421187
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT004211870
Health Conditions in Trial
‌
Febrile neutropenia
0
Trial Recruitment Size
200
Trial Sponsor
Gilead Sciences
Gilead Sciences
0
Clinical Trial Start Date
2007
0
Primary Completion Date
2008
0
Study Completion Date
2008
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 40
Participating Facility
Gilead Sciences
Gilead Sciences
0
Official Name
Phase III Study of 3 Sequential Doses (10 mg/kg, 5 mg/kg, and 5 mg/kg) vs 3 mg/kg/Day of AmBisome® in the Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics0
Last Updated
March 11, 2011
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Liposomal amphotericin B (AmBisome®)0
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.

Timeline

No Timeline data yet.

Further Resources

Title
Author
Link
Type
Date
No Further Resources data yet.

References

Find more entities like Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics

Use the Golden Query Tool to find similar entities by any field in the Knowledge Graph, including industry, location, and more.
Open Query Tool
Access by API
Golden Query Tool
Golden logo

Company

  • Home
  • Press & Media
  • Blog
  • Careers
  • WE'RE HIRING

Products

  • Knowledge Graph
  • Query Tool
  • Data Requests
  • Knowledge Storage
  • API
  • Pricing
  • Enterprise
  • ChatGPT Plugin

Legal

  • Terms of Service
  • Enterprise Terms of Service
  • Privacy Policy

Help

  • Help center
  • API Documentation
  • Contact Us
By using this site, you agree to our Terms of Service.