- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686853
Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis
February 16, 2016 updated by: Hui Bu
Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis Without Acquired Immune Deficiency Syndrome
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui Bu, MD
- Phone Number: 86"
- Email: buhuimy1@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intrathecal administration group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
laboratory examination of cerebrospinal fluid
Time Frame: 2 to 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of clinical symptoms
Time Frame: 2 to 4 weeks
|
headache duration, duration of fever,presence of cranial nerve damage
|
2 to 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of adverse reactions
Time Frame: 24 hours
|
Lower back pain,lower extremity weakness, paraplegia,sphincter disturbance.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hui Bu, MD, The Second Hospital of Hebei Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
January 26, 2016
First Submitted That Met QC Criteria
February 16, 2016
First Posted (Estimate)
February 22, 2016
Study Record Updates
Last Update Posted (Estimate)
February 22, 2016
Last Update Submitted That Met QC Criteria
February 16, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Central Nervous System Infections
- Bacterial Infections and Mycoses
- Mycoses
- Slow Virus Diseases
- HIV Infections
- Meningitis, Fungal
- Central Nervous System Fungal Infections
- Cryptococcosis
- Acquired Immunodeficiency Syndrome
- Meningitis
- Meningitis, Cryptococcal
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Amebicides
- Amphotericin B
- Liposomal amphotericin B
Other Study ID Numbers
- BH 003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cryptococcal Meningitis
-
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