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Mycoses clinical trials

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NCT ID: NCT04273178 Recruiting - Fungal Infection Clinical Trials

Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Start date: January 15, 2020
Phase: Phase 2
Study type: Interventional

This is single arm study to evaluate an escalation anti-fungal prophylaxis protocol for patients undergoing allogeneic stem cell transplantation. For all patients without documented proven or probable invasive fungal disease (IFD), patients will receive fluconazole during the treatment in the laminar air flow units (LAF). After discharged from LAF units, patients will receive anti-mold prophylaxis in case of haplo-identical or HLA-matched unrelated donor transplantation to d+100 without active acute GVHD (aGVHD). In case of active aGVHD, the prophylaxis treatment will be extended until recovery of aGVHD and tapering of immunosuppression. In case of HLA-matched sibling donor, fluconazole will be continued to d+100 and anti-mold prophylaxis will be given in case of active aGVHD.

NCT ID: NCT04256018 Recruiting - Mycosis Fungoides Clinical Trials

Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome

Start date: March 30, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.

NCT ID: NCT04238884 Recruiting - Clinical trials for Invasive Fungal Infections

Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy

VORIGENPHARM
Start date: January 2, 2020
Phase: Phase 4
Study type: Interventional

This is a phase IV pragmatic, multicentre, randomised, simple-blind, parallel arm, centre-stratified clinical trial. The main objective is to compare efficiency of voriconazole preemptive genotyping strategy, compared with routine practice.

NCT ID: NCT04234048 Recruiting - Clinical trials for Peripheral T-cell Lymphoma

Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma

Start date: December 18, 2023
Phase: Phase 1
Study type: Interventional

This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).

NCT ID: NCT04157465 Recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients

Start date: November 7, 2019
Phase: N/A
Study type: Interventional

Early treatment of invasive fungal infections (IFI) may prevent undue mortality in acute on chronic liver failure (ACLF) patients. We aim to study the impact of early empiric treatment (based on clinical suspicion) of IFI as compared to pre-emptive treatment (based on biomarkers and culture positivity) on the outcomes in ACLF patients with suspected IFI in a randomized trial. The ACLF patients with clinically suspected IFI would be randomly allocated to empiric treatment or pre-emptive treatment group and followed up clinically to assess the impact on survival, clinical outcomes and cost-effectiveness and safety of such an approach. The protocol is designed to cut- down unnecessary usage and to curtail the duration of antifungals use in ICUs based on biomarkers/culture-driven stoppage rules. The results will fuel further studies on formal cost-effective analysis and antimicrobial stewardship protocols in ACLF patients.

NCT ID: NCT04118868 Recruiting - Mycosis Fungoides Clinical Trials

Pembrolizumab Administered Via the Sofusa® DoseConnectâ„¢ in Patients With Relapsed/Refractory Cutaneous T-cell Lymphoma.

Start date: August 31, 2022
Phase: Phase 1
Study type: Interventional

In this pilot study, pembrolizumab will be administered via DoseConnect in patient with relapsed or refractory cutaneous T-cell lymphoma to assess through pharmacodynamic assessment in the tumor tissue to assess if lymphatic delivery of pembrolizumab using Sofusa DoseConnect is feasible.

NCT ID: NCT04103840 Recruiting - Clinical trials for Chronic Liver Disease and Cirrhosis

Invasive Fungal Infections in Severe Alcohol-associated Hepatitis

Start date: August 27, 2019
Phase:
Study type: Observational

Chronic alcohol consumption is associated with intestinal bacterial dysbiosis, yet little is known about the role of intestinal fungi, or mycobiota in liver disease. Although the intestinal microbiome contains bacteria, fungi, and viruses, research in the field of liver disease has almost exclusively focused on the interaction between the host and gut bacteria. The fungal microbiota is an integral part of the gastrointestinal micro-ecosystem with up to 106 microorganisms per gram of faeces. Numerous interactions between fungi and bacteria and the complex immune response to gastrointestinal commensal or pathogenic fungi have been demonstrated in prior studies. Alcohol-dependent patients display a reduced intestinal fungal diversity and Candida overgrowth. Compared with healthy individuals and patients with non-alcohol-related cirrhosis, alcoholic cirrhosis patients also demonstrate systemic exposure and immune response to mycobiota. Thus, chronic alcohol consumption is associated with an altered mycobiota and translocation of fungal products. Manipulating the intestinal mycobiome might be an effective strategy for attenuating alcohol-related liver disease especially alcoholic hepatitis. In this study, we will attempt to find out the natural fungal mycobiome in Severe alcoholic hepatitis when compared with apparently healthy asymptomatic controls from their family. This will allow us to therapeutically modify the unbalanced gut microbiota and improve patient outcomes. Secondly, it will provide further insight as to why alcohol-associated hepatitis patients are particularly susceptible to fungal infections. In the age of frequent antibacterial drug therapy, the role of commensal and pathogenic fungi in the human gut has gained paramount importance.

NCT ID: NCT03941951 Recruiting - Clinical trials for Bacterial Infections

Study to Optimize the Use of New Antibiotics

NEW_SAFE
Start date: July 9, 2019
Phase: N/A
Study type: Interventional

Quasi-experimental intervention multicenter trial of patients treated with new antibiotics (before-after study). The study will be carried out in 14 hospitals of the Andalusian Public Health System with representation from all the provinces and has been designed in two phases: 1. A first phase in which an observational study of historical preintervention cohorts of patients who have received either empirical or targeted treatment with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam and isavuconazole from January 2016 to December 2019 will be developed. Case detection will be carried out by locating the antimicrobial prescriptions in the electronic prescribing systems and / or pharmaceutical management systems of each hospital. A set of epidemiological, clinical, microbiological and prognostic variables will be completed in each case. 2. A second phase or intervention period that will be applied to the cohort of patients treated with new antibiotics (intervention cohort) from January 2020 to June 2021. A quasi-experimental intervention study will be carried out through the development of a Program for Optimizing the use of Antibiotics (PROA) in Spanish, Antimicrobial Stewardship Program (ASP) in English, in the participating hospitals. It will consist in the development of a consensus document on the use of new antibiotics following a Delphi methodology, dissemination of the consensus document / guide among the participating hospitals and audit on the prescription of new antimicrobials after the implementation of the guide based on providing non-imposition advice and positive reinforcement to the prescriber. The recommendations will be consigned in a structured form, which will allow to evaluate the degree of follow-up of the recommendations. The audit will be performed on day 0-1 of the prescription. 3. Cohort of bacteremia due to multiresistant microorganisms ("safety" cohort): In order to evaluate the safety of the use of new antimicrobials against therapeutic alternatives in syndromes where they are potentially a preferred option and parallel to the two phases, episodes for bacteremia by carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa, carbapenem-resistant enterobacteria, vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus occurred in participating hospitals from 2017 to 2021 will be collected.

NCT ID: NCT03828773 Recruiting - Clinical trials for Acute Myeloid Leukemia

PTX3-targeted Antifungal Prophylaxis

PTX3AML
Start date: February 11, 2019
Phase: N/A
Study type: Interventional

This is a prospective genetically-stratified randomized double-blind event-driven multicentre clinical trial to assess the efficacy of posaconazole-based antifungal prophylaxis allocation strategies for patients with acute myeloid leukemia who receive induction chemotherapy. Allocation strategy based on an invasive mold infection genetic risk will be double-blinded.

NCT ID: NCT03827694 Recruiting - Clinical trials for Pulmonary Invasive Aspergillosis

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

DOMINIC
Start date: October 30, 2018
Phase:
Study type: Observational

This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).