AmB Dose for Cryptococcal Meningitis | NCT04140461

Studies
AmB Dose for Cryptococcal Meningitis

NCT04140461

Sponsor

Shanghai Public Health Clinical Center

Status

Unknown status

Last Update Posted

Oct 29, 2019Actual

Enrollment

40Estimated

Phase

Phase 3

Conditions

Cryptococcal Meningitis
HIV Infections

Interventions

Amphotericin B
Flucytosine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2020Estimated

Primary Completion Date

Mar 30, 2022Estimated

Completion Date

Apr 30, 2022Estimated

First Submitted Date

Oct 24, 2019

First Submission Date that Met QC Criteria

Oct 24, 2019

First Posted Date

Oct 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2019

Last Update Posted Date

Oct 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Chen, Assistant of the department, Shanghai Public Health Clinical CenterPrincipal Investigator

Lead Sponsor

Shanghai Public Health Clinical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients.

Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trial	Experimental	Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks	Drug: Amphotericin B Drug: Flucytosine
Control	Active Comparator	Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks	Drug: Amphotericin B Drug: Flucytosine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amphotericin B	Drug	The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.	Control Trial

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects died at weeks 48	Mortality in intent to treat population	48 weeks after randomization

Secondary Outcomes

Measure	Description	Time Frame
Number of subjects with CSF culture positive for Cryptococcus at weeks 2	Antifungal Activity	2 weeks after randomization
Number of subjects with disability at weeks 48	Disability rate in intent to treat population

Other Outcomes

Measure	Description	Time Frame
Treatment-Emergent Adverse Events	All the adverse events occurred after randomization	12 weeks after randomization

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed HIV infection
Naive to antiretroviral therapy
Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
Agree to participate the study

Exclusion Criteria:

Having receiving antifungal treatment for ≥3 days
ALT or AST > 5* upper limit of detection (ULD), or neutrophil< 0.5*10E9 cells/L, or hemoglobin < 90g/L or platelet <50*10E9/L or serum creatinine > ULD
Pregnancy or breastfeeding
Concomitant medications that are contraindicated with any research drug
Any other contraindications for using amphotericin B or 5FC
Inability to follow-up as accessed by the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Chen, M.D	Contact	+86-21-37990333	3222	qtchenjun@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Public Health Clinical Center		Shanghai	Shanghai Municipality	201508	China

Condition Browse Module

MeSH Terms

ID	Term
D016919	Meningitis, Cryptococcal
D015658	HIV Infections

Ancestor Terms

ID	Term
D016921	Meningitis, Fungal
D020314	Central Nervous System Fungal Infections
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000666	Amphotericin B
D023241	Antiretroviral Therapy, Highly Active
D005437	Flucytosine

Ancestor Terms

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided