Efficacy of Intrathecal Administration of Liposomal Ampho... | NCT02686853

Studies
Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

NCT02686853

Sponsor

Hui Bu

Status

Unknown status

Last Update Posted

Feb 22, 2016Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Cryptococcal Meningitis

Interventions

Liposomal amphotericin B

Countries

Not provided

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

Feb 2016

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 2016

Primary Completion Date

Jan 2018Estimated

Completion Date

Not provided

First Submitted Date

Jan 26, 2016

First Submission Date that Met QC Criteria

Feb 16, 2016

First Posted Date

Feb 22, 2016Estimated

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

Feb 16, 2016

Last Update Posted Date

Feb 22, 2016Estimated

Description Module

Brief Summary

The main purpose of this study is to observe the clinical effect of intrathecal administration of liposomal amphotericin B in Cryptococcal Meningitis without Acquired Immune Deficiency Syndrome (AIDS).

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 4

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
Intrathecal administration group	Experimental		Drug: Liposomal amphotericin B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liposomal amphotericin B	Drug		Intrathecal administration group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
laboratory examination of cerebrospinal fluid	It includes routine test，biochemistry indicators and cytology ，namely white blood cell count per litre， protein（in g/l），glucose（in mmol/l）and chloride（in mmol/l）in cerebrospinal fluid ，an assessment will be assessed every week	2 to 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
changes of clinical symptoms	headache duration, duration of fever,presence of cranial nerve damage	2 to 4 weeks

Other Outcomes

Measure	Description	Time Frame
The incidence of adverse reactions	Lower back pain，lower extremity weakness， paraplegia，sphincter disturbance.	24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cryptococcus neoformans are found in CSF

Exclusion Criteria:

Patients with serious heart, lung, liver and renal insufficiency.
Patients who took broad-spectrum antibiotics and corticosteroids for a long-term.
Patients with AIDS or obvious immunodeficiency.
Patients with long term dialysis or intravenous catheter.
Patients with other brain organic disease such as purulent meningitis, intracranial swelling, etc.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hui Bu, MD	Contact	86"		buhuimy1@163.com

Overall Officials

Name	Affiliation	Role
Hui Bu, MD	The Second Hospital of Hebei Medical University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016919	Meningitis, Cryptococcal

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
C068538	liposomal amphotericin B

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided