Vulvovaginal CandidiasesPhase 2NCT03167957
Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
A Phase 2 study testing Oral Encochleated Amphotericin B (CAMB) in people with Vulvovaginal Candidiases and Yeast Infection, run by Matinas BioPharma Nanotechnologies, Inc. at 1 site in United States.
Trial summary
This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vulvovaginal Candidiases, Yeast Infection, Vulvovaginitis
- What is being tested?
- Oral Encochleated Amphotericin B (CAMB)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2019to Dec 2020
- Phase
- Phase 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female 18-65 years
- Informed Consent
- Clinical diagnosis of fluconazole-resistant VVC
- Negative pregnancy test
- Vaginal pH ≤ 4.5
Who cannot join
- Intolerance or hypersensitivity to any amphotericin B (AMB) product or to azole antifungal drugs
- Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy
- Received antifungal treatment for VVC within past 10 days except fluconazole, subjects must discontinue fluconazole after informed consent
- Has another cause or suspected cause of vulvovaginitis
- Has active HPV
- Has other urogenital infection
Show all 11Show fewer
- Has other vaginal or vulvar condition that would confound interpretation of clinical response
- Has significant laboratory abnormality at screening
- Has Type I diabetes, use of insulin, HbA1c>10
- Exposure to any investigational product within 30 days of screening
- Has other condition that would interfere with subject ability to provide informed consent or put subject at undue risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).
Read the detailed description
This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).
Approximately 16 women with fluconazole-resistant VVC will be randomized to either 200 mg or 400 mg oral CAMB for 14 days. The primary objectives of this study are to assess the clinical cure rate, mycology eradication and responder outcome. The secondary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB.
- Conditions
- Vulvovaginal Candidiases, Yeast Infection, Vulvovaginitis, Yeast Infection Vaginal, Candidiasis, Vulvovaginal
- Being tested
- Oral Encochleated Amphotericin B (CAMB)
- Keywords
- fluconazole, fluconazole-resistant
- Medical subject headings
- Vulvovaginitis, Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Encochleated Amphotericin B (CAMB)Drug
Also called MAT2203
Lipid-crystal nano-particle formulation amphotericin B
Oral Encochleated Amphotericin B (CAMB)Drug
Also called MAT2203
Lipid-crystal nano-particle formulation amphotericin B
| Study group | Role | What they receive |
|---|---|---|
| CAMB 200 mg | Experimental | 200 mg CAMB Oral Amphotericin B Receives: Drug: Oral Encochleated Amphotericin B (CAMB) |
| CAMB 400 mg | Experimental | 400 mg CAMB Oral Amphotericin B Receives: Drug: Oral Encochleated Amphotericin B (CAMB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with clinical cure at the Test of Cure visit
Resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment
Measured: 28 days
The proportion of subjects with mycological eradication at the Test of Cure visit
Negative culture for growth of baseline Candida
Measured: 28 days
Secondary outcomes (1)
Incidence of treatment emergent adverse events
Safety assessments include laboratory assessments, vital signs and physical exam
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startDec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: No longer target indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167957
- Sponsor's protocol ID
- MB-70008
- Status last verified
- Mar 2019
- First submitted
- 23 May 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 Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT03167957
- Acronym / sponsor ID
- MB-70008
- Conditions
- Vulvovaginal Candidiases, Yeast Infection, Vulvovaginitis, Yeast Infection Vaginal, Candidiasis, Vulvovaginal
- Keywords
- fluconazole, fluconazole-resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer target indication
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 May 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 is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).
Detailed description
This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).
Approximately 16 women with fluconazole-resistant VVC will be randomized to either 200 mg or 400 mg oral CAMB for 14 days. The primary objectives of this study are to assess the clinical cure rate, mycology eradication and responder outcome. The secondary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| CAMB 200 mg | Experimental | Drug: Oral Encochleated Amphotericin B (CAMB)200 mg CAMB Oral Amphotericin B |
| CAMB 400 mg | Experimental | Drug: Oral Encochleated Amphotericin B (CAMB)400 mg CAMB Oral Amphotericin B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female 18-65 years
- Informed Consent
- Clinical diagnosis of fluconazole-resistant VVC
- Negative pregnancy test
- Vaginal pH ≤ 4.5
Key exclusion criteria (11 listed)
- Intolerance or hypersensitivity to any amphotericin B (AMB) product or to azole antifungal drugs
- Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy
- Received antifungal treatment for VVC within past 10 days except fluconazole, subjects must discontinue fluconazole after informed consent
- Has another cause or suspected cause of vulvovaginitis
- Has active HPV
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 |
|---|---|---|
| Oral Encochleated Amphotericin B (CAMB)Also: MAT2203Lipid-crystal nano-particle formulation amphotericin B | Drug | CAMB 200 mg |
| Oral Encochleated Amphotericin B (CAMB)Also: MAT2203Lipid-crystal nano-particle formulation amphotericin B | Drug | CAMB 400 mg |
Primary outcome
The proportion of subjects with clinical cure at the Test of Cure visit
Time frame: 28 days
Resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment
The proportion of subjects with mycological eradication at the Test of Cure visit
Time frame: 28 days
Negative culture for growth of baseline Candida
1 secondary outcome
Incidence of treatment emergent adverse events
Time frame: 28 days
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 Vulvovaginal Candidiases
Recruiting
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
Bacterial Vaginosis, Vaginal Candidiasis
RecruitingObservational study
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Active, not recruitingObservational study
Comparative Performance of a Vaginal Yeast Test
Vulvovaginal Candidiasis
Active, not recruitingObservational study
DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
Vulvovaginal Candidiasis
Not yet recruiting
Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Encochleated Amphotericin B (CAMB) in people with Vulvovaginal Candidiases and Yeast Infection, run by Matinas BioPharma Nanotechnologies, Inc. at 1 site in United States.
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 5 inclusion and 11 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
The proportion of subjects with clinical cure at the Test of Cure visit (time frame: 28 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.