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Trial record 2 of 22 for:    "Vulvitis" | "Steroid Synthesis Inhibitors"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02971007
Recruitment Status : Completed
First Posted : November 22, 2016
Results First Posted : October 5, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Matinas BioPharma Nanotechnologies, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Vulvovaginitis
Yeast Infection
Yeast Infection Vaginal
Candidiasis, Vulvovaginal
Interventions Drug: Oral Encochleated Amphotericin B (CAMB)
Drug: Fluconazole
Enrollment 137
Recruitment Details Recruitment period November 2016 to May 2017 at 22 medical clinics in USA
Pre-assignment Details Enrolled patients were excluded from the study before assignment to groups due to abnormal laboratory test results, negative potassium hydroxide test (KOH) for vaginal yeast or vaginal pH greater than 4.5 during the screening process.
Arm/Group Title CAMB 200 mg CAMB 400 mg Fluconazole 150 mg
Hide Arm/Group Description

200 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

400 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

Fluconazole Diflucan

Fluconazole

Period Title: Overall Study
Started 46 45 46
Completed 44 42 45
Not Completed 2 3 1
Reason Not Completed
Adverse Event             1             0             0
Lost to Follow-up             0             1             1
Withdrawal by Subject             0             1             0
Patient had yeast at Day 5 visit             1             0             0
Patient discontinued study drug             0             1             0
Arm/Group Title CAMB 200 mg CAMB 400 mg Fluconazole 150 mg Total
Hide Arm/Group Description

200 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

400 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

Fluconazole Diflucan

Fluconazole

Total of all reporting groups
Overall Number of Baseline Participants 46 45 46 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 45 participants 46 participants 137 participants
35.7  (12.63) 36.2  (9.77) 34.3  (11.25) 35.4  (11.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 45 participants 46 participants 137 participants
Female
46
 100.0%
45
 100.0%
46
 100.0%
137
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 45 participants 46 participants 137 participants
Hispanic or Latino
20
  43.5%
14
  31.1%
9
  19.6%
43
  31.4%
Not Hispanic or Latino
26
  56.5%
31
  68.9%
37
  80.4%
94
  68.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 45 participants 46 participants 137 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  26.1%
22
  48.9%
24
  52.2%
58
  42.3%
White
34
  73.9%
23
  51.1%
22
  47.8%
79
  57.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 45 participants 46 participants 137 participants
46 45 46 137
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 46 participants 45 participants 46 participants 137 participants
30.49  (8.136) 30.64  (8.411) 29.50  (6.973) 30.21  (7.819)
1.Primary Outcome
Title Clinical Outcome Assessed at Test of Cure Visit
Hide Description 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)
Time Frame 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline
Arm/Group Title CAMB 200 mg CAMB 400 mg Fluconazole 150 mg
Hide Arm/Group Description:

200 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

400 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

Fluconazole Diflucan

Fluconazole

Overall Number of Participants Analyzed 25 22 32
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Cure
13
  52.0%
12
  54.5%
24
  75.0%
Clinical Failure
12
  48.0%
8
  36.4%
7
  21.9%
Clinical Indeterminate
0
   0.0%
2
   9.1%
1
   3.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAMB 200 mg, CAMB 400 mg, Fluconazole 150 mg
Comments No formal sample size calculations were made. The sample size was determined empirically rather than with a specific statistical rationale and is considered sufficient to achieve the study objectives of this proof of concept study. Women with moderate to severe Vulvovaginal candidiasis were randomized in a 1:1:1 ratio to 1 of 3 treatment groups, stratified by signs and symptoms composite score of up to 12 (moderate) and greater than 13 (severe).
Type of Statistical Test Other
Comments Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.
Other Statistical Analysis Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.
2.Secondary Outcome
Title Mycological Outcome Assessed at Test of Cure
Hide Description 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)
Time Frame 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline
Arm/Group Title CAMB 200 mg CAMB 400 mg Fluconazole 150 mg
Hide Arm/Group Description:

200 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

400 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

Fluconazole Diflucan

Fluconazole

Overall Number of Participants Analyzed 25 22 32
Measure Type: Count of Participants
Unit of Measure: Participants
Mycological Eradication
9
  36.0%
7
  31.8%
27
  84.4%
Mycological Persistence
16
  64.0%
13
  59.1%
4
  12.5%
Mycological Indeterminate
0
   0.0%
2
   9.1%
1
   3.1%
3.Secondary Outcome
Title Overall Response
Hide Description 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).
Time Frame 12 Days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline
Arm/Group Title CAMB 200 mg CAMB 400 mg Fluconazole 150 mg
Hide Arm/Group Description:

200 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

400 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

Fluconazole Diflucan

Fluconazole

Overall Number of Participants Analyzed 25 22 32
Measure Type: Count of Participants
Unit of Measure: Participants
Overall Success
4
  16.0%
3
  13.6%
22
  68.8%
Overall Failure
21
  84.0%
17
  77.3%
9
  28.1%
Overall Indeterminate
0
   0.0%
2
   9.1%
1
   3.1%
4.Secondary Outcome
Title Change in Composite Clinical Cure Score
Hide Description

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.

Time Frame Between randomization visit (Baseline) and Day 12 visit (Test of Cure)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline
Arm/Group Title CAMB 200 mg CAMB 400 mg Fluconazole 150 mg
Hide Arm/Group Description:

200 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

400 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

Fluconazole Diflucan

Fluconazole

Overall Number of Participants Analyzed 25 22 32
Mean (Standard Deviation)
Unit of Measure: percent change
-80.9  (24.63) -80.1  (44.66) -94.0  (13.71)
Time Frame Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CAMB 200 mg CAMB 400 mg Fluconazole 150 mg
Hide Arm/Group Description

200 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

400 mg CAMB (MAT2203) Oral Amphotericin B

Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B

Fluconazole Diflucan

Fluconazole

All-Cause Mortality
CAMB 200 mg CAMB 400 mg Fluconazole 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)      0/45 (0.00%)      0/46 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
CAMB 200 mg CAMB 400 mg Fluconazole 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/46 (0.00%)      0/45 (0.00%)      0/46 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
CAMB 200 mg CAMB 400 mg Fluconazole 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/46 (21.74%)      12/45 (26.67%)      4/46 (8.70%)    
Gastrointestinal disorders       
Diarrhoea  1  2/46 (4.35%)  2 3/45 (6.67%)  3 0/46 (0.00%)  0
Nausea  1  3/46 (6.52%)  3 2/45 (4.44%)  2 1/46 (2.17%)  1
Infections and infestations       
Bacterial Vaginosis  1  3/46 (6.52%)  3 5/45 (11.11%)  5 2/46 (4.35%)  2
Urinary Tract Infection  1  2/46 (4.35%)  2 2/45 (4.44%)  2 1/46 (2.17%)  1
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Data may be considered for publication in a scientific journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data pertaining to the study confidential and must consult with the Sponsor before any study data are submitted for publication. Sponsor reserves the right to deny publication rights until mutual agreement on the content, format, interpretation of data in the manuscript, and journal selected for publication are achieved.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Clinical Development
Organization: Matinas Biopharma
Phone: 9082953235
EMail: jjohnson@matinasbiopharma.com
Layout table for additonal information
Responsible Party: Matinas BioPharma Nanotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT02971007     History of Changes
Other Study ID Numbers: MB-70005
First Submitted: November 10, 2016
First Posted: November 22, 2016
Results First Submitted: September 7, 2018
Results First Posted: October 5, 2018
Last Update Posted: November 2, 2018