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Candidiasis clinical trials

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NCT ID: NCT02818803 Completed - Candidiasis, Oral Clinical Trials

Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic

Start date: January 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of propolis on the treatment of oral candidiasis, more specifically denture stomatitis. Half of participants will receive a standardized-propolis (EPP-AF®) gel formulation while the other half will receive miconazole gel, both for oral use.

NCT ID: NCT02801682 Completed - Clinical trials for Invasive Candidiasis

NOBICS - NOvel BIomarker In Invasive CandidiasiS/Candida Sepsis

NOBICS
Start date: June 2016
Phase:
Study type: Observational

Invasive Candida infections are serious complications in immunocompromised patients including those undergoing treatment for cancer but occur also in patients treated in ICUs. Survival rate of invasive candidiasis is associated with early initiation of antifungal therapy (15% mortality rate for candidemic patients with antifungal therapy on day 0 related to the culture date of the first blood sample positive for yeasts compared to 41% for patients who received antifungal therapy on day 3). Up to date, no laboratory method or clinical decision rule is available for correct anticipation of invasive candidiasis which would avoid delays in appropriate antifungal therapy initiation. In clinical practice culture based methods (e.g. blood cultures) miss up to 50% of invasive candidiasis cases. Preemptive antifungal therapy is therefore often initiated in critically ill patients after Candida has been isolated from various non-sterile patient samples even without any sufficient evidence for invasive candidiasis. The disadvantages of this approach include over- and undertreatment of patients (up to 50% of candidemia cases are missed, and on the other hand 89% patients are treated unnecessarily), increased selective pressure for the development of antifungal resistance, potential risk of adverse drug reactions, and increased costs (expenses for antifungal therapy account for half of the antimicrobial medication budget in tertiary care hospitals). In addition, no survival benefit could be demonstrated by this strategy in ICU patients. The aim of this study is to identify biological markers to anticipate or support the diagnosis of invasive candidiasis in ICU patients, to overcome current deficiencies in detection of invasive candidiasis and consequently to differentiate between Candida spp. colonization and invasive Candida infection. The investigators intend to examine time dependent courses of potential host and pathogen derived biomarkers as well as innate or acquired predispositions for invasive candidiasis; e.g. automated (1→3) ß- D- Glucan tests, DNA in serum blood samples, pathogen recognition receptors and serum markers like interleukin (IL)-1, IL-2, IL-6, IL-10, IL-12, IL-17A, IL-17F, IL-22, IL-23, Tryptophan, Kynurenine, composition of indigenous microbiota of gastrointestinal and lower respiratory tract and skin, and risk factors for invasive candidiasis like underlying diseases and treatments. The study should contribute to improved assessment of ICU patients at risk for invasive candidiasis and to improved diagnosis of invasive candidiasis in ICU patients. In clinical practice the reliable differentiation between infection and colonization will allow more targeted antifungal therapy leading to enhanced antifungal treatment initiation on the one hand (in cases of true invasive candidiasis) and to reduction of unnecessary antifungal treatments and treatment costs on the other hand.

NCT ID: NCT02795845 Completed - Clinical trials for Bacterial Vaginosis and Vaginal Candidiasis at Pregnancy

Oral Probiotics for the Treatment and Prevention of Vulvovaginal Infections in Pregnancy - Double-blind, Randomized, Placebo-controlled Study

Start date: November 2016
Phase: N/A
Study type: Interventional

During pregnancy, bacterial vaginosis (BV), abnormal vaginal flora (AVF) and vulvovaginal candidiasis (VVC) are associated with serious complications and discomfort. Yet, treatment options are limited. Lactobacilli administration was suggested to treat and prevent vaginal infections. However, this has not been examined in pregnant women, the information regarding oral treatment is scarce, and the mechanisms in which oral ingestion of probiotics induce vaginal lactobacilli proliferation are not well established. In the present study we will examine if oral probiotics are effective in prevention of vaginal infections by migration of lactobacilli from the digestive system to the vagina in pregnant women.

NCT ID: NCT02734862 Completed - Fungal Infection Clinical Trials

CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension

STRIVE
Start date: July 26, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).

NCT ID: NCT02734550 Completed - Septic Shock Clinical Trials

(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis

CandiSep
Start date: September 12, 2016
Phase: N/A
Study type: Interventional

This prospective randomized multicenter study evaluates whether the decision to prescribe antifungals guided by (1,3)-β-D-glucan in comparison to standard of care shortens time to antifungal therapy and reduces mortality in patients with severe sepsis or septic shock and a high risk of invasive candida infection.

NCT ID: NCT02733432 Completed - Mycoses Clinical Trials

RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections

Start date: June 8, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.

NCT ID: NCT02730494 Completed - Clinical trials for Candidiasis, Vulvovaginal

Study Evaluating the Optimal Dosage for Equivalence Between Lcr Regenerans® Capsules and Tablets (Lactobacillus Rhamnosus Lcr35®) on the Vaginal Flora Colonisation

COMPRIGEL
Start date: July 2015
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to study the vaginal flora colonisation equivalence between the tablet and capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment.

NCT ID: NCT02679456 Completed - Clinical trials for Vulvovaginal Candidiasis

Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis

Start date: November 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.

NCT ID: NCT02666716 Completed - Candidiasis Clinical Trials

Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients

PACIFIC
Start date: May 2015
Phase:
Study type: Observational

The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine fluconazole and free fluconazole concentrations in 20 ICU patients, who will get intravenous fluconazole as standard care. Switching to oral/enteral fluconazol is allowed after day 3. A full pharmacokinetic curve will be taken on day 3 of iv therapy and limited pharmacokinetic curves on day 7 of iv therapy and/or on day 3 of oral therapy; trough levels will be taken daily after intravenous therapy.

NCT ID: NCT02646800 Terminated - Candidiasis Clinical Trials

Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

Start date: March 21, 2014
Phase: Phase 4
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of intravenous micafungin for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.