Cryptococcal MeningitisPhase 4NCT02686853
Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis
A Phase 4 study testing Liposomal amphotericin B in people with Cryptococcal Meningitis, run by Hui Bu.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cryptococcal Meningitis
- What is being tested?
- Liposomal amphotericin B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cryptococcus neoformans are found in CSF
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
- Conditions
- Cryptococcal Meningitis
- Being tested
- Liposomal amphotericin B
- Keywords
- Intrathecal administration, Liposomal amphotericin B, Without Acquired Immune Deficiency Syndrome
- Medical subject headings
- Meningitis, Cryptococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal amphotericin BDrug
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal administration group | Experimental | Not described Receives: Drug: Liposomal amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 to 4 weeks
Secondary outcomes (1)
changes of clinical symptoms
headache duration, duration of fever,presence of cranial nerve damage
Measured: 2 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptococcal MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui Bu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Bu, Hebei Medical University
- Investigators
- Hui Bu, MD, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686853
- Sponsor's protocol ID
- BH 003
- Status last verified
- Feb 2016
- First submitted
- 26 Jan 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis Without Acquired Immune Deficiency Syndrome
- ClinicalTrials.gov ID
- NCT02686853
- Acronym / sponsor ID
- BH 003
- Conditions
- Cryptococcal Meningitis
- Keywords
- Intrathecal administration, Liposomal amphotericin B, Without Acquired Immune Deficiency Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hui BuUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrathecal administration group | Experimental | Drug: Liposomal amphotericin B |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cryptococcus neoformans are found in CSF
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal amphotericin B | Drug | Intrathecal administration group |
Primary outcome
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
1 secondary outcome
changes of clinical symptoms
Time frame: 2 to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
Related trials for Cryptococcal Meningitis
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
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Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Not yet recruitingPhase 3
Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
Cryptococcal Antigenemia, HIV-1-infection
RecruitingPhase 2/3
Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)
Hiv, Cryptococcal Meningitis
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Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
Cryptococcal Meningitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Bu, MD principal investigator
The Second Hospital of Hebei Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal amphotericin B in people with Cryptococcal Meningitis, run by Hui Bu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Bu, MD (86", buhuimy1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laboratory examination of cerebrospinal fluid (time frame: 2 to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.