Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
NCT ID: NCT02971007
Last Updated: 2018-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
137 participants
INTERVENTIONAL
2016-11-30
2017-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CAMB 200 mg
200 mg CAMB (MAT2203) Oral Amphotericin B
Oral Encochleated Amphotericin B (CAMB)
lipid-crystal nano-particle formulation amphotericin B
CAMB 400 mg
400 mg CAMB (MAT2203) Oral Amphotericin B
Oral Encochleated Amphotericin B (CAMB)
lipid-crystal nano-particle formulation amphotericin B
Fluconazole 150 mg
Fluconazole Diflucan
Fluconazole
Interventions
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Oral Encochleated Amphotericin B (CAMB)
lipid-crystal nano-particle formulation amphotericin B
Fluconazole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Clinical diagnosis of moderate to severe VVC
Negative pregnancy test
Vaginal pH less than 4.5
Exclusion Criteria
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
18 Years
65 Years
FEMALE
No
Sponsors
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Matinas BioPharma Nanotechnologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas Kling
Role: STUDY_DIRECTOR
Matinas BioPharma Nanotechnologies, Inc.
Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Precision Trials, LLC
Phoenix, Arizona, United States
National Research Institute - Wilshire
Los Angeles, California, United States
South Florida Medical Research
Aventura, Florida, United States
Neostart Corporation dba AGA Clinical Trials
Hialeah, Florida, United States
Altus Research
Lake Worth, Florida, United States
Advanced Research Institute Inc
New Port Richey, Florida, United States
Healthcare Clinical Data, Inc.
North Miami, Florida, United States
Clinical Research of West Florida - Tampa
Tampa, Florida, United States
Visions Clinical Research
Wellington, Florida, United States
Mt. Vernon Clinical Research - Wake Research
Atlanta, Georgia, United States
Brighton Clinical Research Associates
Norcross, Georgia, United States
Medpharmics
Metairie, Louisiana, United States
New England Center for Clinical Research, Inc.
Fall River, Massachusetts, United States
Lawrence OB/GYN
Lawrenceville, New Jersey, United States
ProHEALTH Care Associates, LLC - Suffolk OB-GYN
Port Jefferson, New York, United States
PMG Research of Salisbury, LLC.
Salisbury, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Complete Health Care for Women
Columbus, Ohio, United States
Study Center
Columbus, Ohio, United States
Jackson Clinic
Jackson, Tennessee, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Tidewater Clinical Research, Inc.
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MB-70005
Identifier Type: -
Identifier Source: org_study_id
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