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Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis

NCT05471063 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-07-22

No results posted yet for this study

Summary

To evaluate the efficacy and safety of ABCD in the treatment of cryptococcal meningitis in non-HIV patients at week 4, the end of induction therapy, week 10 and the end of consolidation therapy.

Conditions

  • Cryptococcal Meningitis

Interventions

DRUG

Amphotericin B Colloidal Dispersion

Amphotericin B Colloidal Dispersion 3.0-4.0 mg/kg/d (subject to adjustment, maximum dose not exceeding 6.0 mg/kg/d) . The course of induction therapy is at least four weeks.

DRUG

flucytosine

Flucytosine 100 mg/kg/d for induction therapy and consolidation therapy of cryptococcal meningitis. The course of induction therapy is at least four weeks, and consolidation therapy for at least 6 weeks.

DRUG

fluconazole

Fluconazole (400-600 mg/d) for consolidation therapy for at least 6 weeks.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Group Co., Ltd.

    collaborator UNKNOWN

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Taisheng Li, PhD · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2023-02-28
Completion
2023-04-30

Countries

  • China

Study Locations

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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 NCT05471063 on ClinicalTrials.gov