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NCT Number: NCT02971007

Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of 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.

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Key information

Conditions

Vulvovaginitis Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Yeast Infection Yeast Infection Vaginal

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Alabama Clinical Therapeutics, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Informed consent

Clinical diagnosis of moderate to severe VVC

Negative pregnancy test

Vaginal pH less than 4.5

Key Exclusion Criteria:

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

Treatment and study plan

Oral Encochleated Amphotericin B (CAMB)

Drug

lipid-crystal nano-particle formulation amphotericin B

Other names: MAT2203

Fluconazole

Drug

Primary outcomes

  1. 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)

Secondary outcomes

  1. Mycological Outcome Assessed at Test of Cure

    Time frame: 12 days

    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)

  2. Overall Response

    Time frame: 12 Days

    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).

  3. Change in Composite Clinical Cure Score

    Time frame: Between randomization visit (Baseline) and Day 12 visit (Test of Cure)

    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.

Sponsors and collaborators

Lead sponsor

Matinas BioPharma Nanotechnologies, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2016
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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