Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421187
Status:
TERMINATED
Last Update Posted:
2011-03-11
First Post:
2007-01-08
Brief Title:
Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Phase III Study of 3 Sequential Doses 10 mgkg 5 mgkg and 5 mgkg vs 3 mgkgDay of AmBisome in the Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics
Status:
TERMINATED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit subjects in the Turkey site
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Administration of a single high dose 10 mgkg of AmBisome no later than 72 hours after ARNF onset followed by two 5 mgkg 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 mgkgday 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 mgkg because of the lower cumulative dosage 20 mgkg versus 42 mgkg 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
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 recruited
Patients will be adults with hematological malignancies undergoing chemotherapy for leukemia or lymphoma These patients will be treated with AmBisome until resolution of fever and neutropenia or for a maximum of 14 days
Patients will be randomized to receive AmBisome 10 mgkg on treatment day 0 followed by 5 mgkg on days 2 and 5 or AmBisome 3 mgkgday for 14 days Study medication will be administered during the period of ARNF until resolution of fever and neutropenia andor a minimum of 14 days At the end of the 14-day trial period each patient will be classified as having responded or not responded to the treatment according to the criteria for response given below
Patients will be examined daily for evidence of drug toxicity or intolerance and for the development of an IFI Vital signs will be recorded every 6 hours if the patient is stable or more frequently if there is evidence of clinical deterioration In the event of a clinical IFI ie development of a halo sign or positive fungal blood cultures the patient will be withdrawn from the study classified as treatment failure and receive antifungal treatment with either caspofungin or voriconazole Daily clinical observations will ensure rapid detection of such an event in accordance with standard IDSA guidelines4 Patients who show clinical deterioration ie increasing dyspnea hypotension but exhibit no definite evidence of an IFI may also be classified as treatment failures Patients with evidence of biochemical andor clinical drug toxicity will be withdrawn from the study and appropriate management will be given
For patients who remain febrile after 14 days but who are otherwise stable and have no discernable cause for the fever continuation of treatment with AmBisome 3 mgkgday or treatment with another antifungal drug treatment antibiotic or discontinuation of antimicrobial therapy will be undertaken at the discretion of the investigator Patients who meet these criteria will have a thorough diagnostic evaluation to investigate the cause of their fever
Patients will be adults with hematological malignancies undergoing chemotherapy for leukemia or lymphoma These patients will be treated with AmBisome until resolution of fever and neutropenia or for a maximum of 14 days
Patients will be randomized to receive AmBisome 10 mgkg on treatment day 0 followed by 5 mgkg on days 2 and 5 or AmBisome 3 mgkgday for 14 days Study medication will be administered during the period of ARNF until resolution of fever and neutropenia andor a minimum of 14 days At the end of the 14-day trial period each patient will be classified as having responded or not responded to the treatment according to the criteria for response given below
Patients will be examined daily for evidence of drug toxicity or intolerance and for the development of an IFI Vital signs will be recorded every 6 hours if the patient is stable or more frequently if there is evidence of clinical deterioration In the event of a clinical IFI ie development of a halo sign or positive fungal blood cultures the patient will be withdrawn from the study classified as treatment failure and receive antifungal treatment with either caspofungin or voriconazole Daily clinical observations will ensure rapid detection of such an event in accordance with standard IDSA guidelines4 Patients who show clinical deterioration ie increasing dyspnea hypotension but exhibit no definite evidence of an IFI may also be classified as treatment failures Patients with evidence of biochemical andor clinical drug toxicity will be withdrawn from the study and appropriate management will be given
For patients who remain febrile after 14 days but who are otherwise stable and have no discernable cause for the fever continuation of treatment with AmBisome 3 mgkgday or treatment with another antifungal drug treatment antibiotic or discontinuation of antimicrobial therapy will be undertaken at the discretion of the investigator Patients who meet these criteria will have a thorough diagnostic evaluation to investigate the cause of their fever
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None