Cryptococcal InfectionsPhase 1/2ORACLENCT03196921
Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection
A Phase 1/2 study testing Encochleated Amphotericin B in people with Cryptococcal Infections, run by Matinas BioPharma Nanotechnologies, Inc..
Trial summary
This will be an open label phase I/II prospective cohort study to determine the efficacy and safety of CAMB for the treatment and prevention of cryptococcal infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptococcal Infections
- What is being tested?
- Encochleated Amphotericin B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Mar 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection, informed consent, cryptococcal infection present, diagnosed by either: CSF cryptococcal culture, CSF cryptococcal antigen (CRAG), plasma/serum CRAG
Who cannot join
- Presence of jaundice or known liver cirrhosis, >72 hours antifungal therapy, pregnancy or breastfeeding, unlikely to attend regular clinic visits
About this study
Official title: A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection
This will be an open label phase I/II prospective cohort study to determine the efficacy and safety of CAMB for the treatment and prevention of cryptococcal infection.
- Conditions
- Cryptococcal Infections
- Being tested
- Encochleated Amphotericin B
- Keywords
- amphotericin B, cryptococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encochleated Amphotericin BDrug
Also called CAMB, MAT2203
lipid-crystal nanoparticle formulation of amphotericin B; oral
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic Cryptococcal Meningitis | Experimental | CAMB (Encochleated Amphotericin B) Receives: Drug: Encochleated Amphotericin B |
| Asymptomatic Cryptococcal Antigenemia | Experimental | CAMB (Encochleated Amphotericin B) Receives: Drug: Encochleated Amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of drug over 14 days of dosing
Tolerability of drug as measured by the proportion of doses received versus the number of scheduled doses
Measured: 14-days
Microbiologic clearance of Cryptococcus from the CSF
Measured: 14-days
Secondary outcomes (4)
Incidence of adverse events
stratified by symptomatic and asymptomatic subgroups
Measured: 14-days
Survival from cryptococcal infection
stratified by symptomatic and asymptomatic subgroups
Measured: 10-weeks
Pharmacokinetics
PK parameter of Area Under the Curve (AUC)
Measured: 24-hours
Pharmacokinetics
PK parameter of the maximum concentration (Cmax)
Measured: 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Why it stopped: Protocol redundancy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptococcal InfectionsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients with symptomatic cryptococcal meningitis will be enrolled in treatment arm Patients that are CRAG positive will be enrolled the in prevention arm
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- David R Boulware, MD, MPH, Principal investigator, University of MinnesotaTafese Beyene Tufa, Principal investigator, Asella Teaching Hospital, Arsi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196921
- Sponsor's protocol ID
- MB-70009
- Acronym
- ORACLE
- Status last verified
- Mar 2019
- First submitted
- 19 Jun 2017
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection
- ClinicalTrials.gov ID
- NCT03196921
- Acronym / sponsor ID
- ORACLE / MB-70009
- Conditions
- Cryptococcal Infections
- Keywords
- amphotericin B, cryptococcal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol redundancy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 23 Jun 2017 (actual)
- 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.
This will be an open label phase I/II prospective cohort study to determine the efficacy and safety of CAMB for the treatment and prevention of cryptococcal infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with symptomatic cryptococcal meningitis will be enrolled in treatment arm Patients that are CRAG positive will be enrolled the in prevention arm
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Cryptococcal Meningitis | Experimental | Drug: Encochleated Amphotericin BCAMB (Encochleated Amphotericin B) |
| Asymptomatic Cryptococcal Antigenemia | Experimental | Drug: Encochleated Amphotericin BCAMB (Encochleated Amphotericin B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV infection, informed consent, cryptococcal infection present, diagnosed by either: CSF cryptococcal culture, CSF cryptococcal antigen (CRAG), plasma/serum CRAG
Key exclusion criteria (1 listed)
- Presence of jaundice or known liver cirrhosis, >72 hours antifungal therapy, pregnancy or breastfeeding, unlikely to attend regular clinic visits
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 |
|---|---|---|
| Encochleated Amphotericin BAlso: CAMB, MAT2203lipid-crystal nanoparticle formulation of amphotericin B; oral | Drug | Asymptomatic Cryptococcal Antigenemia, Symptomatic Cryptococcal Meningitis |
Primary outcome
Tolerability of drug over 14 days of dosing
Time frame: 14-days
Tolerability of drug as measured by the proportion of doses received versus the number of scheduled doses
Microbiologic clearance of Cryptococcus from the CSF
Time frame: 14-days
4 secondary outcomes
Incidence of adverse events
Time frame: 14-days
Survival from cryptococcal infection
Time frame: 10-weeks
Pharmacokinetics
Time frame: 24-hours
Pharmacokinetics
Time frame: 24-hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Cryptococcal Infections
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
RecruitingObservational study
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
Not yet recruiting
Advanced HIV Re-engagement in Care
Advanced HIV Disease
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.
David R Boulware, MD, MPH principal investigator
University of Minnesota
Tafese Beyene Tufa principal investigator
Asella Teaching Hospital, Arsi University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Encochleated Amphotericin B in people with Cryptococcal Infections, run by Matinas BioPharma Nanotechnologies, Inc..
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 1 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: withdrawn, as of the sponsor's last update on 8 Mar 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of drug over 14 days of dosing (time frame: 14-days). The study lists 2 primary outcomes in all. 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 8 Mar 2019.