ClinicalTrials.gg
Status unknownNCT02686853Updated Feb 22, 2016

Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

A Phase 4 interventional study of Liposomal amphotericin B in Cryptococcal Meningitis, sponsored by Hui Bu. Status unknown. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2016-02-22.

Sponsored by Hui Bu · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
14 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Cryptococcal Meningitis

Keywords

  • Intrathecal administration
  • Liposomal amphotericin B
  • Without Acquired Immune Deficiency Syndrome
03

In context

Meningitis, Cryptococcal

54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.

This study's planned enrollment of 40 is below the median of 143 across 35 interventional studies indexed under Meningitis, Cryptococcal.

Browse Meningitis, Cryptococcal studies →

Lead sponsor

Hui Bu is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Cryptococcus neoformans are found in CSF

Exclusion criteria

Exclusion Criteria:

  • Patients with serious heart, lung, liver and renal insufficiency.
  • Patients who took broad-spectrum antibiotics and 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Intrathecal administration group

    Drug: Liposomal amphotericin B

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 to 4 weeks

Secondary outcomes

  1. changes of clinical symptoms

    headache duration, duration of fever,presence of cranial nerve damage

    Time frame: 2 to 4 weeks

Other outcomes

  1. The incidence of adverse reactions

    Lower back pain,lower extremity weakness, paraplegia,sphincter disturbance.

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2016 and a primary completion of Jan 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2016
First posted
Feb 22, 2016
Start
Jan 2016
Primary completionEst.
Jan 2018
Last update
Feb 22, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02686853
Lead sponsor
Hui Bu
Responsible party
Hui Bu (Study Principal Investigator, Hebei Medical University) — Sponsor-investigator
First posted
Feb 22, 2016
Start date
Jan 2016
Primary completion
Jan 2018 (estimated)
Last update
Feb 22, 2016

Study contacts

Hui Bu, MD
Contact
buhuimy1@163.com
86"
Hui Bu, MD
principal investigator · The Second Hospital of Hebei Medical University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Liposomal amphotericin B

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