Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334412
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2006-06-05
Brief Title:
COMBISTRAT AmBisome in Combination With Caspofungin for the Treatment of Invasive Aspergillosis
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
AmBisome in Combination With Caspofungin Versus AmBisome High Dose Regimen for the Treatment of Invasive Aspergillosis in Immunocompromized Patients Randomized Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Combination therapy of caspofungin and amphotericin B could be a useful treatment option in invasive fungal disease but before it can be routinely recommended carefully controlled and well-designed randomized clinical trials are needed
Detailed Description:
Efficacy and toxicity of caspofungin in combination with AmBisome as primary or salvage treatment of invasive aspergillosis has already been assessed in patients with hematologic malignancies Forty-eight patients with documented n23 or possible n25 Invasive Aspergillosis IA The majority of the patients 65 received the combination as salvage therapy for progressive IA despite 7 or more days of previous AmBisome monotherapy The overall response rate was 42 No significant toxic effects were seen Factors associated with failure at the end of therapy were documented IA P003 significant steroid use before the study P002 and duration of combination therapy for less than 14 days P001 The response rate in patients with progressive documented IA was low 18 Authors concluded that combination is a promising therapy for IA and was generally well tolerated35 Furthermore interaction of caspofungin and amphotericin B for clinical isolates of Aspergillus and Fusarium was assessed Antagonism was not observed for any of the isolates tested Caspofungin and amphotericin B were synergistic or synergistic to additive for at least half of the isolates studied36 Gentina et al evaluated in refractory IA iv antifungal therapies combining caspofungin 70 mg on D1 followed by 50 mgd with Vfend 200 mg bid or AmBisome 5 mgkgd Six leukaemia patients with refractory IA received combination including caspofungin with AmBisome n 4 or Vfend n 2 Combination therapies were started 8 days after initial IA diagnosis Duration of neutropenia after initiation of combination therapy ranged 4 to 25 days IA was classified as definite in 3 cases and probable in 3 cases All patients had pulmonary IA including one with disseminated IA cerebral thyroid ocular and pulmonary In all patients sequential CT-scans demonstrated improvement with a rapid reduction of the size of lesions Additional surgery was only required in 2 cases Improvement allowed administration of consolidation chemotherapy in 3 patients without recurrence of IA Median duration of combination therapy was 62 days range 42-107 No toxicity related to this combination antifungal therapy was observed37 The combination therapy of caspofungin and amphotericin or liposomal amphotericin was also assessed by Aliff et al in a retrospective evaluation of a group of 30 patients with amphotericin-resistant pulmonary aspergillosis and other invasive fungal infections Twenty-six patients had acute leukemia Diagnosis was based on clinical radiographic and when available microbiologic data Response to combination antifungal therapy was graded as either favorable or unfavorable Favorable responses included improvement of both clinical and radiographic signs of fungal pneumonia All other responses were graded as unfavorable Based on the EORTC criteria the IFIs were classified as proven in 6 patients probable in 4 patients and possible in 20 patients The median duration and dose of amphotericin monotherapy were 12 days range 4-65 days and 78 mgkg range 42-661 mgkgrespectively The median duration of combination therapy was 24 days range 3-74 days Eighteen patients 60 experienced a favorable antifungal response Twenty patients with acute leukemia received combination therapy for fungal pneumonias arising during intensive chemotherapy treatments Favorable responses were observed in 15 of these patients 75 and antifungal response did not depend on the response of the underlying leukemia Survival to hospital discharge was significantly better P 0001 in patients having a favorable response Authors concluded that the combination of caspofungin and amphotericin B can be administered safely to high-risk patients with hematologic malignancies38 Combination therapy could be a useful treatment option in invasive fungal disease but before it can be routinely recommended carefully controlled and well-designed randomized clinical trials are needed
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