Clinical trials: Isavuconazole
Cerebral Aspergillosis, Invasive Aspergillosis
European Study of Cerebral Aspergillosis Treated With Isavuconazole
Study clinical context Cerebral aspergillosis (CA) is a rare location of invasive aspergillosis (IA), associated with a high morbidity and mortality.
- Trial name
- ESCAI (NCT04486885)
- Where
- France
- Volunteers
- 41 people
- Sponsor
- Imagine Institute
Severe Acute Respiratory Syndrome Coronavirus 2, Aspergillosis Invasive
Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis
The objective of this study is to evaluate whether antifungal prophylaxis with isavuconazole can reduce the incidence of SARS-CoV-2-associated invasive aspergillosis in patients in the ICU (intensive care unit) with severe…
- Trial name
- Isavu-CAPA (NCT04707703)
- Testing
- Isavuconazonium Injection [Cresemba]
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Jeffrey Jenks, MD, MPH
Aspergillosis, Invasive Fungal Infection
Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.
- Trial name
- NCT00412893
- Testing
- Isavuconazole, Voriconazole
- Where
- 107 sites in United States, Argentina and 24 more
- Volunteers
- 527 people
- Sponsor
- Astellas Pharma Inc
Mucormycosis in Hematologic Malignancies
Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety
This clinical trial, a single-arm prospective study, aims to evaluate the efficacy and safety of liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole in treating adult patients with malignant…
- Trial name
- NCT07185503
- Testing
- liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole
- Where
- 9 sites in China
- Volunteers
- 60 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Methadone
Drug Interaction Study of Isavuconazole and Methadone
The primary purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of methadone after single dose administration.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Methadone, Healthy Volunteers
- Trial name
- NCT01582425
- Testing
- Isavuconazole, Methadone
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Healthy Volunteers
Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects
The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy non-elderly and elderly male and female subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Healthy Volunteers, Safety and Tolerability in Elderly
- Trial name
- NCT01657890
- Testing
- isavuconazole
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia
Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy
Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal…
- Trial name
- NCT00413439
- Testing
- Isavuconazole
- Where
- 4 sites in Germany
- Volunteers
- 18 people
- Sponsor
- Basilea Pharmaceutica
Hematologic Malignancy, Myeloproliferative Disorder
Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
The purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (HCT).
- Trial name
- NCT03149055
- Testing
- Isavuconazole
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Pharmacokinetics of 14C-labeled Isavuconazole, Healthy Subjects
Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.
- Trial name
- NCT01813461
- Testing
- 14C-labeled prodrug isavuconazonium sulfate
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Invasive Fungal Disease
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
This study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger Chinese population who will receive isavuconazole treatment in a post-marketing…
- Trial name
- NCT05630976
- Testing
- Isavuconazole
- Where
- 14 sites in China
- Volunteers
- 70 people
- Sponsor
- Pfizer
Invasive Fungal Infections, Lung Transplantation
Isavuconazole Therapeutic Drug Monitoring in Transplant Recipients
Isavuconazole is an antifungal medicine used to prevent or treat serious fungal infections in people who have received a solid organ transplant (mainly lung, and also kidney or liver) or a hematopoietic stem cell (bone marrow)…
- Conditions
- Invasive Fungal Infections, Lung Transplantation, Hematopoietic Stem Cell Transplantation (HSCT), Kidney Transplantation
- Trial name
- TRIM-1 (NCT07716878)
- Testing
- Isavuconazole
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Zhibin Xu
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ethinyl Estradiol and Norethindrone
Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ethinyl Estradiol and Norethindrone, Healthy Volunteers
- Trial name
- NCT01597986
- Testing
- isavuconazole, Oral Contraceptive (ethinyl estradiol / norethindrone)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Midazolam
Drug Interaction Study of Isavuconazole and Midazolam
The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Midazolam, Healthy Volunteers
- Trial name
- NCT01406171
- Testing
- Isavuconazole, Midazolam
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Invasive Mucormycosis, Invasive Aspergillosis
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
- Trial name
- NCT03816176
- Testing
- Isavuconazonium sulfate
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 31 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Digoxin
Drug Interaction Study of Isavuconazole and Digoxin
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of digoxin in healthy adult subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Digoxin, Healthy Volunteers
- Trial name
- NCT01582412
- Testing
- Isavuconazole, digoxin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia
This phase II trial studies how well isavuconazole works in preventing invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Neutropenia
- Trial name
- NCT03019939
- Testing
- Isavuconazole
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- M.D. Anderson Cancer Center
Invasive Fungal Disease
Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD（ Breakthrough Invasive Fungal Disease） in Patients With Malignant Hematological Diseases
This is a prospective, open label, controlled, single center real-world observational study. Adult (aged ≥ 18 years) patients with hematological malignancies develop breakthrough invasive fungal disease after receiving ≥ 7 days…
- Trial name
- NCT07135778
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Isavuconazole, Invasion Pulmonary Mycosis
Individualized Precision Isavuconazole Therapy Guided by PK/PD Principles for the Geriatric Population
Esconazole, as a novel triazole antifungal drug, has broad-spectrum antifungal activity, good tissue penetration and low toxicity risk.
- Trial name
- NCT07496008
- Testing
- Liquid chromatography-tandem mass spectrometry
- Volunteers
- 150 people
- Sponsor
- Chinese PLA General Hospital
Bacterial Infections, Fungal Infection
Study to Optimize the Use of New Antibiotics
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…
- Trial name
- NEW_SAFE (NCT03941951)
- Testing
- Non-impositive Program for Optimizing the Use of Antimicrobials
- Where
- 14 sites in Spain
- Volunteers
- 900 people
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Healthy Subjects, Pharmacokinetics of Isavuconazole
A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration.
- Conditions
- Healthy Subjects, Pharmacokinetics of Isavuconazole, Pharmacokinetics of Plasma Mycophenolic Acid (MPA), Pharmacokinetics of Plasma Phenolic Glucuronide of MPA (MPAG)
- Trial name
- NCT01711489
- Testing
- isavuconazole, Mycophenolate mofetil
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.