Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178627
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-21
First Post:
2023-12-04
Brief Title:
Amphotericin B for Non-HIV Cryptococcal Meningitis Patients
Sponsor:
Huashan Hospital
Organization:
Huashan Hospital
Study Overview
Official Title:
A Multi-center Prospective Randomized Trial of Amphotericin B in the Initial Antifungal Therapy for Non-HIV Cryptococcal Meningitis Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
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:
ABNCM
Brief Summary:
Cryptococcus neoformans and C gatti are important causes of central nervous system CNS infections with significant mortality remaining a great public health challenge worldwide Commonly seen as an opportunistic infection in adults with HIVAIDS cryptococcal meningitis CM accounts for 15 of HIV-related mortality globally 1 In addition a growing number of non-HIV CM patients have been observed in recent years with fatality approaching 30 in some areas 23 It occurs in both those with natural or iatrogenic immunosuppression as well as the apparently immunocompetent individuals Approximately 65-70 of non-HIV CM patients were without any predisposing factors particularly in the East Asia 45 With the increasing number of hematopoietic stem cell transplantation solid organ transplantation recipients and administration of immunosuppressive and corticosteroids agents this illness will assume even greater public health significance
Current Infectious Disease Society of America IDSA guideline suggest the use of combination antifungal therapy normal dose amphotericin 07-1mgkgday combined with flucytosine for a minimum of 4 weeks followed by fluconazole 600-800 mgday for a minimum of 10 weeks in total for HIV patients 6 However for non-HIV and immunocompetent patients the treatment remains controversial IDSA guideline recommended that the treatment of non-HIV patients could refer to the treatment of HIV patients That is amphotericin B combined with flucytosine is still administered in the induction period However as amphotericin B have nonspecific effect on ergosterol it has strong side effects hepatorenal toxicity electrolyte disorder anemia ventricular fibrillation etc Therefore the dose of amphotericin B may not be appropriate for Asian patients due to the different drug metabolism and pharmacokinetic In the prospective studies of Bennett7 and Dismuke8 low dose amphotericin B 03 mgkgd combined with flucytosine achieved response rates of 66 and 85 at 6 weeks respectively A similar conclusion was also extracted from a large multicenter retrospective study that low dose amphotericin B lt07 mgkgd combined with flucytosine for a minimum of 2 weeks followed by fluconazole could achieve a response rate of 84 indicating that the efficacy of low dose amphotericin B lt 07 mgkgd may be equivalent with normal dose in non-HIV patients Therefore we plan to conduct a prospective multicenter open-label randomized controlled study to compare the efficacy and safety of normal dose amphotericin B 07 mgkg d and low dose amphotericin B 05 mgkgd in the initial antifungal treatment for non-HIV cryptococcal meningitis patients
Current Infectious Disease Society of America IDSA guideline suggest the use of combination antifungal therapy normal dose amphotericin 07-1mgkgday combined with flucytosine for a minimum of 4 weeks followed by fluconazole 600-800 mgday for a minimum of 10 weeks in total for HIV patients 6 However for non-HIV and immunocompetent patients the treatment remains controversial IDSA guideline recommended that the treatment of non-HIV patients could refer to the treatment of HIV patients That is amphotericin B combined with flucytosine is still administered in the induction period However as amphotericin B have nonspecific effect on ergosterol it has strong side effects hepatorenal toxicity electrolyte disorder anemia ventricular fibrillation etc Therefore the dose of amphotericin B may not be appropriate for Asian patients due to the different drug metabolism and pharmacokinetic In the prospective studies of Bennett7 and Dismuke8 low dose amphotericin B 03 mgkgd combined with flucytosine achieved response rates of 66 and 85 at 6 weeks respectively A similar conclusion was also extracted from a large multicenter retrospective study that low dose amphotericin B lt07 mgkgd combined with flucytosine for a minimum of 2 weeks followed by fluconazole could achieve a response rate of 84 indicating that the efficacy of low dose amphotericin B lt 07 mgkgd may be equivalent with normal dose in non-HIV patients Therefore we plan to conduct a prospective multicenter open-label randomized controlled study to compare the efficacy and safety of normal dose amphotericin B 07 mgkg d and low dose amphotericin B 05 mgkgd in the initial antifungal treatment for non-HIV cryptococcal meningitis patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None