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Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02686853
Recruitment Status : Unknown
Verified February 2016 by Hui Bu, Hebei Medical University.
Recruitment status was:  Not yet recruiting
First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Information provided by (Responsible Party):
Hui Bu, Hebei Medical University

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).

Condition or disease Intervention/treatment Phase
Cryptococcal Meningitis Drug: Liposomal amphotericin B Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis Without Acquired Immune Deficiency Syndrome
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Meningitis

Arm Intervention/treatment
Experimental: Intrathecal administration group Drug: Liposomal amphotericin B

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. changes of clinical symptoms [ Time Frame: 2 to 4 weeks ]
    headache duration, duration of fever,presence of cranial nerve damage

Other Outcome Measures:
  1. The incidence of adverse reactions [ Time Frame: 24 hours ]
    Lower back pain,lower extremity weakness, paraplegia,sphincter disturbance.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02686853

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Contact: Hui Bu, MD 86"

Sponsors and Collaborators
Hui Bu
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Principal Investigator: Hui Bu, MD The Second Hospital of Hebei Medical University

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Responsible Party: Hui Bu, Study Principal Investigator, Hebei Medical University Identifier: NCT02686853     History of Changes
Other Study ID Numbers: BH 003
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Keywords provided by Hui Bu, Hebei Medical University:
Intrathecal administration
Liposomal amphotericin B
Without Acquired Immune Deficiency Syndrome
Additional relevant MeSH terms:
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Meningitis, Cryptococcal
Acquired Immunodeficiency Syndrome
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Central Nervous System Infections
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents