Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
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)
1 other identifier
interventional
137
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 10, 2016
CompletedFirst Posted
Study publicly available on registry
November 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
October 5, 2018
CompletedNovember 2, 2018
October 1, 2018
6 months
November 10, 2016
September 7, 2018
October 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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)
12 days
Secondary Outcomes (3)
Mycological Outcome Assessed at Test of Cure
12 days
Overall Response
12 Days
Change in Composite Clinical Cure Score
Between randomization visit (Baseline) and Day 12 visit (Test of Cure)
Study Arms (3)
CAMB 200 mg
EXPERIMENTAL200 mg CAMB (MAT2203) Oral Amphotericin B
CAMB 400 mg
EXPERIMENTAL400 mg CAMB (MAT2203) Oral Amphotericin B
Fluconazole 150 mg
ACTIVE COMPARATORFluconazole Diflucan
Interventions
lipid-crystal nano-particle formulation amphotericin B
Eligibility Criteria
You may qualify if:
- Informed consent
- Clinical diagnosis of moderate to severe VVC
- Negative pregnancy test
- Vaginal pH less than 4.5
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Alabama Clinical Therapeutics
Birmingham, Alabama, 35205, United States
Precision Trials, LLC
Phoenix, Arizona, 85032, United States
National Research Institute - Wilshire
Los Angeles, California, 90057, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Neostart Corporation dba AGA Clinical Trials
Hialeah, Florida, 33012, United States
Altus Research
Lake Worth, Florida, 33461, United States
Advanced Research Institute Inc
New Port Richey, Florida, 34653, United States
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161, United States
Clinical Research of West Florida - Tampa
Tampa, Florida, 33603, United States
Visions Clinical Research
Wellington, Florida, 33414, United States
Mt. Vernon Clinical Research - Wake Research
Atlanta, Georgia, 30328, United States
Brighton Clinical Research Associates
Norcross, Georgia, 30092, United States
Medpharmics
Metairie, Louisiana, 70006, United States
New England Center for Clinical Research, Inc.
Fall River, Massachusetts, 02720, United States
Lawrence OB/GYN
Lawrenceville, New Jersey, 08648, United States
ProHEALTH Care Associates, LLC - Suffolk OB-GYN
Port Jefferson, New York, 11777, United States
PMG Research of Salisbury, LLC.
Salisbury, North Carolina, 28144, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Complete Health Care for Women
Columbus, Ohio, 43231, United States
Study Center
Columbus, Ohio, 43231, United States
Jackson Clinic
Jackson, Tennessee, 38305, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Tidewater Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This is a proof of concept study not designed or powered to support an indication for the treatment of VVC but to establish safety, tolerability and efficacy in a non-life threatening fungal infection.
Results Point of Contact
- Title
- Director Clinical Development
- Organization
- Matinas Biopharma
Study Officials
- STUDY DIRECTOR
Douglas Kling
Matinas BioPharma Nanotechnologies, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2016
First Posted
November 22, 2016
Study Start
November 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
November 2, 2018
Results First Posted
October 5, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share