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Aspergillosis clinical trials

View clinical trials related to Aspergillosis.

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NCT ID: NCT03920527 Completed - Clinical trials for Chronic Pulmonary Aspergillosis

Six Months Versus 12 Months of Oral Itraconazole Therapy for Management of Treatment naïve Subjects With CPA

Start date: July 1, 2019
Phase: Phase 3
Study type: Interventional

The treatment options majorly consist of medical management with at least 6-month long treatment with antifungal drugs - most significantly the azole groups. Itraconazole is the preferred azole for the treatment of CPA. The duration of treatment with oral itraconazole remains uncertain. In a previous study the use of oral itraconazole for 6-months a favorable overall response was seen in 76% of the subjects. Moreover, about 30%-50% of the subjects have disease relapse that requires prolonged therapy. It is likely that a longer duration of itraconazole would have a higher response rate and thus, lower risk of relapse after discontinuation of therapy. In this randomized controlled trial, we compare the clinical outcomes of six months versus twelve months of itraconazole therapy in treatment naïve subjects with chronic pulmonary aspergillosis

NCT ID: NCT03816176 Completed - Clinical trials for Invasive Aspergillosis

A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants

Start date: August 22, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.

NCT ID: NCT03731169 Completed - Fungal Infection Clinical Trials

CYP2C19 Genotype-Specific Dosing Plus TDM on Reaching Therapeutic Voriconazole Blood Levels

Start date: January 10, 2018
Phase: Phase 4
Study type: Interventional

Invasive aspergillosis is a fungal infection which left untreated, is a significant cause of morbidity and mortality. Immunocompromised patient populations such as solid organ transplant and malignant hematology patients are especially susceptible to invasive fungal infections. Voriconazole is an anti-fungal agent that is frontline therapy for invasive aspergillosis. Treatment success is highly dependent on maintaining therapeutic voriconazole concentrations. The current published literature has established that treatment failure is associated with sub- and supra-therapeutic voriconazole concentrations. Maintaining therapeutic voriconazole concentrations however, is challenging due to the high inter and intra-patient variability in voriconazole pharmacokinetics. The complex kinetics of voriconazole renders current manufacturers' dosing guidelines ineffective. Much of this complexity has been linked to genetic polymorphisms in the cytochrome P450 2C19 gene, and it has been found that CYP2C19 genotype plays an important role in determining voriconazole exposure levels. Therapeutic drug monitoring has been found to increase efficacy of voriconazole treatment through the monitoring of patients' voriconazole levels, allowing for dosage adjustments in response to supra- or sub-therapeutic levels. There are few robust studies that have examined the effect of CYP2C19 genotype on voriconazole treatment outcomes. They have been unable to determine relationships between CYP2C19 genetic status, and clinical efficacy and safety. No studies to our knowledge have made dosing adjustments based on CYP2C19 genetic status. The study aim is to explore the utility of voriconazole dosing that is based on the genetic status of the patient in conjunction with therapeutic drug monitoring. Over the course of one year, solid organ transplant recipients at Toronto General Hospital and malignant hematology patients at Princess Margaret Cancer Centre receiving voriconazole therapy will be randomized into one of two trial arms: a control arm receiving therapeutic drug monitoring only, or a treatment arm receiving genotype-specific dosing in conjunction with therapeutic drug monitoring. The investigators will compare the proportion of patients that achieve voriconazole therapeutic concentrations, the number of dose adjustments needed to achieve therapeutic voriconazole levels, and clinical outcomes between trial arms.

NCT ID: NCT03672292 Completed - Clinical trials for Invasive Pulmonary Aspergillosis

Study to Evaluate the Safety and Efficacy of the Coadministration of Ibrexafungerp (SCY-078) With Voriconazole in Patients With Invasive Pulmonary Aspergillosis

SCYNERGIA
Start date: January 22, 2019
Phase: Phase 2
Study type: Interventional

Study to evaluate the safety and efficacy of coadminstration of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole in patients with invasive pulmonary aspergillosis.

NCT ID: NCT03641131 Completed - Fungal Infection Clinical Trials

Ampholipad Real-World Data in Taiwan

Start date: September 9, 2018
Phase:
Study type: Observational

A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.

NCT ID: NCT03443336 Completed - Clinical trials for Pulmonary Aspergillosis

Azole-resistance in Aspergillus

Start date: June 1, 2017
Phase:
Study type: Observational

Prospective multi-center surveillance study on the prevalence of azole-resistant Aspergillus spp. in clinical isolates of patients with pulmonary colonization or invasive infections in Switzerland

NCT ID: NCT03391492 Completed - Clinical trials for Influenza With Pneumonia

Invasive Pulmonary Aspergillosis Complicating Influenza Infection

Start date: January 20, 2018
Phase:
Study type: Observational

Study the incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients with severe influenza and in influenza-negative control patients with severe community-acquired pneumonia

NCT ID: NCT03378479 Completed - Clinical trials for Aspergillosis; Pulmonary, Invasive (Etiology)

Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients

POSA-FLU
Start date: December 27, 2017
Phase: Phase 4
Study type: Interventional

The objective of this study is to deliver proof of concept that antifungal prophylaxis can reduce the incidence of Influenza Associated Aspergillosis (IAA) in ICU (intensive care unit) patients with severe influenza. The investigators will perform an interventional non-blinded randomized controlled multicentric proof-of-concept study in patients with severe influenza admitted to the ICU. Patients will be randomized to the posaconazole prophylaxis group or to the SOC (standard of care) group. Oseltamivir will be started at the discretion of the investigator. Patients in the posaconazole group will receive posaconazole prophylaxis for 7 days. addendum: pharmacokinetics of posaconazole as prophylaxis for invasive fungal disease on ICU

NCT ID: NCT03349931 Completed - Clinical trials for Invasive Aspergillosis in Patients With Onco-haematological Diseases

Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis

MYCOGENIE
Start date: February 5, 2018
Phase:
Study type: Observational

The purpose of this study is to evaluate the performances of the real-time PCR ADEMTECH kit of DNA extraction and detection of Aspergillus fumigatus in serum samples in patients at high-risk for invasive aspergillosis (IA). DNA detection will be associated with detection of TR34/L98H mutations in cyp51A gene, which confer azole resistance.

NCT ID: NCT03340597 Completed - Clinical trials for Invasive Aspergillosis

Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects

Start date: December 12, 2017
Phase: Phase 1
Study type: Interventional

A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally . The effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the pharmacokinetics of midazolam will also be assessed.