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Candidiasis, Invasive clinical trials

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NCT ID: NCT04225195 Not yet recruiting - Clinical trials for Invasive Aspergillosis

Amphotericin B Cholesteryl Sulfate Complex for Injection(ABCD) in the Treatment of Invasive Candidiasis and Invasive Aspergillosis

Start date: January 2020
Phase: Phase 2
Study type: Interventional

This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis.

NCT ID: NCT04148287 Completed - Candidemia Clinical Trials

An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris

APEX
Start date: December 13, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, single arm study to evaluate the efficacy and safety of APX001 for the treatment of candidemia and/or invasive candidiasis caused by C. auris in patients aged 18 years and over with limited antifungal treatment options.

NCT ID: NCT03997929 Completed - Critically Ill Clinical Trials

Peritoneal 1.3-ß-D-glucan for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients (pBDG2)

pBDG2
Start date: January 20, 2020
Phase:
Study type: Observational [Patient Registry]

New rapid diagnostic strategies are warranted in intra-abdominal candidiasis (IAC). A previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-Beta-D-Glucan ≤ 310pg/ml could rule out an IAC. This strategy was independent of the patient underlying conditions and Candida risk factors. This study aimed to confirm these results with a multicenter prospective study

NCT ID: NCT03906916 Terminated - Clinical trials for Invasive Candidiasis

Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin

EPICA1
Start date: July 18, 2018
Phase: Phase 4
Study type: Interventional

EPICA-1 is a multicenter, open label, interventional study which will involve about 30 Internal Medicine Units throughout Italy, enrolling globally at least 100 hospitalised patients with suspicion of invasive candidiasis. These patients will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test: this will allow collection of information on patients outcome. At the same time, patients will be also evaluated by means of blood culture, so that comparison will be possible between the two diagnostic tests (primary end-point of the study).

NCT ID: NCT03717623 Recruiting - Pharmacokinetics Clinical Trials

Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants

POPULAR
Start date: August 1, 2019
Phase: Phase 4
Study type: Interventional

The purpose of the study is to investigate the pharmacokinetics of oral dosage of Posaconazole which is routinely administered as a standard care prophylaxis for patients undergoing cancer treatments.

NCT ID: NCT03667690 Completed - Fungal Infection Clinical Trials

Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis

ReSTORE
Start date: October 7, 2018
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT03538912 Recruiting - Clinical trials for Invasive Candidiasis

Early Discontinuation of Empirical Antifungal Therapy and Biomarkers

SEAT
Start date: June 6, 2018
Phase: N/A
Study type: Interventional

Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse. The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality. To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.

NCT ID: NCT03468803 Completed - Clinical trials for Invasive Candidiases

Influence of Open and Laparoscopic Abdominal Surgery Involving the Intestinal Tract on Serum 1,3-ß-D-Glucan (BDG) Values

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Candida species are both known to colonize physiologically mucosal surfaces in the human body without causing signs or symptoms of infection and to cause a wide variety of diseases, including mucocutaneous infections and potentially fatal invasive infections of the bloodstream or organs. Throughout the past decades, invasive fungal infections (IFIs) are of increasing importance even in non-neutropenic patients who are in need of treatment in intensive care units (ICU) or have undergone major surgeries. Several factors like parenteral nutrition, central venous catheters, broad spectrum antibiotics admission, disturbance of gastrointestinal mucosa integrity have been associated with an increased incidence of IFIs. Positive testing for 1,3-ß-D-Glucan (BDG) in serum is widely used to assess invasive fungal infections. It detects circulating BDG, which is part of the fungal cell wall of clinical relevant fungi such as Candida spp. and Aspergillus spp.. The issue of BDG kinetics after intestinal mucosal damage (e.g. mucositis or gut surgery) is poorly understood. Intestinal mucosal damage is characterized by a loss of integrity of the intestinal mucosal barrier and increasing translocations of bacterial and/or fungal commensals of the gastrointestinal tract. In abdominal surgery a key concern in serum BDG kinetics is the potential introduction of BDG from surgical sponges and gauze or mucosal damage due to surgical damage of the mucosal integrity. Compared to open abdominal surgery in laparoscopic abdominal surgery sponges and gauze are rarely used. As life-threatening intraabdominal candidiasis occurs in 30 to 40% of high-risk abdominal surgical intensive care unit (ICU) patients it is of utmost importance to obtain reliable BDG values for diagnosis or exclusion of invasive candidiasis.

NCT ID: NCT03450005 Recruiting - Clinical trials for Invasive Candidiases

ECMM Candida Registry - CandiReg

CandiReg
Start date: January 18, 2018
Phase:
Study type: Observational

The objective of the European Confederation of Medical Mycology - ECMM Candida Registry (CandiReg) is to overcome the lack of knowledge on epidemiology, clinical course, and molecular characteristics of invasive infections due to invasive Candida infections and to function as a platform for future studies and in case of outbreaks.

NCT ID: NCT03363841 Completed - Candidemia Clinical Trials

Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)

CARES
Start date: November 15, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.