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Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis

Candidiasis, Vulvovaginal Clinical Trial

Official title:
A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis

Clinical Trial Summary

This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).

Clinical Trial Description

This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).

Approximately 16 women with fluconazole-resistant VVC will be randomized to either 200 mg or 400 mg oral CAMB for 14 days. The primary objectives of this study are to assess the clinical cure rate, mycology eradication and responder outcome. The secondary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03167957
Study type Interventional
Source Matinas BioPharma Nanotechnologies, Inc.
Contact
Status Withdrawn
Phase Phase 2
Start date December 2019
Completion date December 2020
View Details
See also
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