VulvovaginitisPhase 2NCT02971007
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
A Phase 2 study testing Oral Encochleated Amphotericin B (CAMB) and Fluconazole in people with Vulvovaginitis and Yeast Infection, run by Matinas BioPharma Nanotechnologies, Inc. at 23 sites in United States.
Trial summary
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vulvovaginitis, Yeast Infection, Yeast Infection Vaginal
- What is being tested?
- Oral Encochleated Amphotericin B (CAMB) and Fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 23 sitesUnited States
- Study dates
- Nov 2016to May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Informed consent
- Clinical diagnosis of moderate to severe VVC
- Negative pregnancy test
- Vaginal pH less than 4.5
Who cannot join
- Has an 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
- Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months
- Has another cause of vulvovaginitis
- Has other urogenital infection(s) that would potentially alter their response to disease
- Has another vaginal or vulvar condition that would confound the interpretation of clinical response
Show all 9Show fewer
- Has significant laboratory abnormality at screening
- Has any known azole-resistant Candida infection;
- Has any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Mt. Vernon Clinical Research - Wake Research
Atlanta, Georgia, 30328
South Florida Medical Research
Aventura, Florida, 33180
Alabama Clinical Therapeutics
Birmingham, Alabama, 35205
Complete Health Care for Women
Columbus, Ohio, 43231
Study Center
Columbus, Ohio, 43231
New England Center for Clinical Research, Inc.
Fall River, Massachusetts, 02720
Neostart Corporation dba AGA Clinical Trials
Hialeah, Florida, 33012
Jackson Clinic
Jackson, Tennessee, 38305
Altus Research
Lake Worth, Florida, 33461
Lawrence OB/GYN
Lawrenceville, New Jersey, 08648
National Research Institute - Wilshire
Los Angeles, California, 90057
Medpharmics
Metairie, Louisiana, 70006
Advanced Research Institute Inc
New Port Richey, Florida, 34653
Brighton Clinical Research Associates
Norcross, Georgia, 30092
Tidewater Clinical Research, Inc.
Norfolk, Virginia, 23502
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161
Precision Trials, LLC
Phoenix, Arizona, 85032
ProHEALTH Care Associates, LLC - Suffolk OB-GYN
Port Jefferson, New York, 11777
PMG Research of Salisbury, LLC.
Salisbury, North Carolina, 28144
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Clinical Research of West Florida - Tampa
Tampa, Florida, 33603
Visions Clinical Research
Wellington, Florida, 33414
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
About this study
Official title: A Multi-Center Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis (VVC)
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
Read the detailed description
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in each group. The primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe VVC. The secondary efficacy objectives of this study included the clinical cure rate, mycology eradication and responder outcome. Tertiary objectives include pharmacokinetics.
- Being tested
- Oral Encochleated Amphotericin B (CAMB), Fluconazole
- 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
FluconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| CAMB 200 mg | Experimental | 200 mg CAMB (MAT2203) Oral Amphotericin B Receives: Drug: Oral Encochleated Amphotericin B (CAMB) |
| CAMB 400 mg | Experimental | 400 mg CAMB (MAT2203) Oral Amphotericin B Receives: Drug: Oral Encochleated Amphotericin B (CAMB) |
| Fluconazole 150 mg | Active comparator | Fluconazole Diflucan Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome Assessed at Test of Cure Visit
Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)
Measured: 12 days
Secondary outcomes (3)
Mycological Outcome Assessed at Test of Cure
Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated)
Measured: 12 days
Overall Response
Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure).
Measured: 12 Days
Change in Composite Clinical Cure Score
The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome.
The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome.
Measured: Between randomization visit (Baseline) and Day 12 visit (Test of Cure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VulvovaginitisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Kling, Study director, Matinas BioPharma Nanotechnologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971007
- Sponsor's protocol ID
- MB-70005
- Status last verified
- Oct 2018
- First submitted
- 10 Nov 2016
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis (VVC)
- ClinicalTrials.gov ID
- NCT02971007
- Acronym / sponsor ID
- MB-70005
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Posted 5 Oct 2018
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 multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
Detailed description
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in each group. The primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe VVC. The secondary efficacy objectives of this study included the clinical cure rate, mycology eradication and responder outcome. Tertiary objectives include pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAMB 200 mg | Experimental | Drug: Oral Encochleated Amphotericin B (CAMB)200 mg CAMB (MAT2203) Oral Amphotericin B |
| CAMB 400 mg | Experimental | Drug: Oral Encochleated Amphotericin B (CAMB)400 mg CAMB (MAT2203) Oral Amphotericin B |
| Fluconazole 150 mg | Active comparator | Drug: FluconazoleFluconazole Diflucan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent
- Clinical diagnosis of moderate to severe VVC
- Negative pregnancy test
- Vaginal pH less than 4.5
Key exclusion criteria (9 listed)
- Has an 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
- Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months
- Has another cause of vulvovaginitis
- Has other urogenital infection(s) that would potentially alter their response to disease
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, CAMB 400 mg |
| Fluconazole | Drug | Fluconazole 150 mg |
Primary outcome
Clinical Outcome Assessed at Test of Cure Visit
Time frame: 12 days
Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)
3 secondary outcomes
Mycological Outcome Assessed at Test of Cure
Time frame: 12 days
Overall Response
Time frame: 12 Days
Change in Composite Clinical Cure Score
Time frame: Between randomization visit (Baseline) and Day 12 visit (Test of Cure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Douglas Kling study director
Matinas BioPharma Nanotechnologies, Inc.
23 sites 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) and Fluconazole in people with Vulvovaginitis and Yeast Infection, run by Matinas BioPharma Nanotechnologies, Inc. at 23 sites 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
Yes. Results are posted in the registry (first posted 5 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Outcome Assessed at Test of Cure Visit (time frame: 12 days). 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 2 Nov 2018.