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Invasive Aspergillosis clinical trials

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NCT ID: NCT06382922 Recruiting - Clinical trials for Invasive Aspergillosis

Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy

Start date: March 29, 2023
Phase:
Study type: Observational

In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA [43 probable (1.7%) and 13 proven (0.5%)]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC). The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course. In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP.

NCT ID: NCT06344117 Recruiting - Clinical trials for Invasive Aspergillosis

Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients

UHN
Start date: December 12, 2023
Phase:
Study type: Observational

Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD).

NCT ID: NCT06069505 Recruiting - Clinical trials for Invasive Aspergillosis

Detection of Azole Resistance Inducing Mutations on DNA Extracted Directly From Serum or Plasma of Immunocompromised Patients With an Invasive Aspergillus Infection Azole Resistance PCR Optimalization-study

ARPO
Start date: July 15, 2017
Phase:
Study type: Observational

Invasive aspergillosis (IA) is the most common mould infection in immunocompromised patients with haematological disease. Voriconazole, a triazole, improves overall survival of patients with an IA and is the mainstay of therapy. Resistance of A. Fumigatus emerged as an important clinical problem and infections with azole resistant Aspergillus have a high mortality. Nowhere in the world, azole resistance is more prevalent than in the Netherlands. Rapid detection of resistance is key to improve the patient's outcome but fungal cultures take time and are often negative. The investigators aim to detect azole resistance associated mutations in fungal DNA extracted directly from serum or plasma to accelerate diagnosis and improve outcome of patients infected with azole resistant A. fumigatus.

NCT ID: NCT06028451 Recruiting - Clinical trials for Invasive Aspergillosis

ManagemEnt of Antifungal Drug in Invasive Aspergillosis:a Real-word Study

Start date: September 25, 2023
Phase:
Study type: Observational [Patient Registry]

To assessed the current situation and outcome of critically ill patients with invasive aspergillus infection.

NCT ID: NCT05101187 Recruiting - Clinical trials for Invasive Aspergillosis

Olorofim Aspergillus Infection Study

OASIS
Start date: March 31, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

NCT ID: NCT04876716 Recruiting - Clinical trials for Invasive Aspergillosis

Azole-echinocandin Combination Therapy for Invasive Aspergillosis

IA-DUET
Start date: May 11, 2021
Phase: Phase 3
Study type: Interventional

The goals of this study are 3-fold: First, the main study and the primary endpoint will evaluate if the overall mortality can be decreased with initial azole-echinocandin combination therapy compared with triazole monotherapy in patients with IA and documented voriconazole susceptibility. Second, the study design described will also allow to study several other subpopulations; Indeed, the outcome of the following subgroups will be evaluated as well; a. Patients starting azole monotherapy but who switch to directed therapy when it has become clear that the infection is caused by an azole resistant A. fumigatus. b. patients in which eventually no resistance data become available in relation to the treatment they received. Third, the study will evaluate what the outcome is of patients that turn out to be infected with a triazole resistant A. fumigatus who started with a triazole-echinocandin combination therapy.

NCT ID: NCT04486885 Recruiting - Clinical trials for Invasive Aspergillosis

European Study of Cerebral Aspergillosis Treated With Isavuconazole

ESCAI
Start date: August 1, 2021
Phase:
Study type: Observational

Study clinical context Cerebral aspergillosis (CA) is a rare location of invasive aspergillosis (IA), associated with a high morbidity and mortality. Since 2002, voriconazole is the recommended first line treatment of invasive aspergillosis. More recently, isavuconazole appeared to be not less effective than voriconazole in the treatment of filamentous IFI, with a better tolerance profile. The investigators aim to evaluate better the efficacy and the safety of isavuconazole in the treatment of cerebral aspergillosis by a descriptive, multicentric, international retrospective cohort 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: NCT03014934 Recruiting - Clinical trials for Invasive Aspergillosis

Impact of Pre-existing Invasive Aspergillosis on Allogeneic Stem Cell Transplantation

IPAT
Start date: January 2016
Phase:
Study type: Observational

Via a prospective non-interventional study clinical outcome of patients with - and without - history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in terms of non-relapse mortality overall mortality and fungal infectious morbidity. Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of pre-existing IA vs. no pre-existing IA. Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of 10%) than patients without pre-existing IA. Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell grafts. Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of probable or proven invasive aspergillosis: this cohort includes also the patient with a history of possible mycosis not documented microbiologically.

NCT ID: NCT01386437 Recruiting - Clinical trials for Invasive Aspergillosis

Natural History of Individuals With Immune System Problems That Lead to Fungal Infections

Start date: November 5, 2012
Phase:
Study type: Observational

Background: - The immune system is made up of special cells, tissues, and organs that fight infections. Problems with this system may lead to frequent, severe, or unusual fungal infections. These infections are often difficult to treat. Researchers want to collect blood and tissue samples from people who have unusual, persistent or severe fungal infections or immune problems that increase the risk of these infections. Objectives: - To collect medical information and samples for a long-term study of people with immune system problems that lead to fungal infections. Eligibility: - People with a history of fungal infections caused by immune system problems. - Parents, children, and siblings of this group. - Healthy volunteers not related to the first two groups. Design: - This long-term study may last for up to 10 years. Those in the study may need to provide new information about every 6 months. The procedures for each person may vary with the particular diagnosis and the extent of fungal infection. Healthy volunteers may have only one or two visits. - At the first visit, those in the study will have a full medical history and physical exam. They will also provide blood. - Research procedures may include the following: - Saliva, urine or stool testing - Mouthwash collection for DNA testing - Collection of cheek cells, nail clippings, or vaginal fluid - Tests of leftover tissue or body fluid from previous medical procedures - Skin or oral mucous membrane biopsy - Collection of white blood cells - Followup visits will involve a physical exam and updated medical history. Blood, saliva, urine, or nail clipping samples may be taken for ongoing studies. Any additional tests or exams required by the study doctors may also be done. - Participants may withdraw from the study pool at any time.