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Azole Antifungal

Isavuconazonium sulfate for Mucormycosis

Phase 2
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 84 and end of treatment (eot) (up to a maximum of 180 days) (average duration of treatment: 57.7 days)
Awards & highlights

Study Summary

This trial will test how safe and effective isavuconazonium sulfate is in children.

Eligible Conditions
  • Mucormycosis
  • Invasive Aspergillosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 84 and end of treatment (eot) (up to a maximum of 180 days) (average duration of treatment: 57.7 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 84 and end of treatment (eot) (up to a maximum of 180 days) (average duration of treatment: 57.7 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Percentage of Participants With All - Cause Mortality Through Day 42
Secondary outcome measures
Percentage of Participants With All - Cause Mortality
Percentage of Participants With Clinical Response: AC Assessment
Percentage of Participants With Clinical Response: Investigator Assessment
+6 more

Side effects data

From 2022 Phase 2 trial • 31 Patients • NCT03816176
29%
Pyrexia
26%
Diarrhoea
23%
Vomiting
16%
Stomatitis
16%
Non-cardiac chest pain
13%
Hypokalaemia
13%
Nausea
13%
Aphthous ulcer
13%
Hypoalbuminaemia
10%
Dry skin
10%
Abdominal distension
10%
Tachycardia
10%
Thrombocytopenia
10%
Septic shock
10%
Anaemia
10%
Respiratory distress
10%
Rhinorrhoea
10%
Hypertension
10%
Rhinitis
10%
Pruritus
10%
Tachypnoea
10%
Hypotension
10%
Epistaxis
10%
Headache
10%
Cough
10%
Lymphopenia
10%
Abdominal pain
10%
Constipation
6%
Dysuria
6%
Hyperkalaemia
6%
Transaminases increased
6%
Neutropenia
6%
Petechiae
6%
Urticaria
6%
Febrile neutropenia
6%
Chills
6%
Folliculitis
6%
Hypophosphataemia
6%
Dyspnoea
6%
Pain
6%
Pain in extremity
6%
Rash
6%
QRS axis abnormal
6%
Pallor
6%
Pulmonary oedema
6%
Ear pain
6%
COVID-19
6%
Oral herpes
6%
Arthralgia
6%
Muscle spasms
6%
Hypoxia
6%
Drug hypersensitivity
6%
Lung opacity
6%
Oropharyngeal pain
3%
Infusion site pruritus
3%
Bacteraemia
3%
Bacterial sepsis
3%
Pneumonia
3%
Brain abscess
3%
Pericardial effusion
3%
Pneumococcal sepsis
3%
Pleural effusion
3%
Infusion site pain
3%
Streptococcal sepsis
3%
Venoocclusive liver disease
3%
Synovitis
3%
Respiratory failure
3%
Social problem
3%
Infusion related reaction
3%
Cardio-respiratory arrest
3%
Circulatory collapse
3%
Sepsis
3%
Vascular device infection
3%
Injection site reaction
3%
Rhabdomyolysis
3%
Haemoptysis
3%
Anuria
3%
Escherichia sepsis
3%
Graft versus host disease
3%
Pneumonia pseudomonal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Isavuconazonium Sulfate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Isavuconazonium sulfateExperimental Treatment1 Intervention
Participants received 10 milligrams/killograms (mg/kg) dose of isavuconazonium sulfate every 8 hours (± 2 hours) on days 1 and 2 for a total of 6 doses (via intravenous or oral administration at the investigator's discretion) followed by once-daily maintenance dose of 10 mg/kg for up to 84 days IA or 180 days IM or until the participant had a successful outcome as judged by the investigator, whichever occured first. The route of administration could have been changed per the investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isavuconazonium sulfate
2019
Completed Phase 2
~2050

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,031 Total Patients Enrolled
Executive DirectorStudy DirectorAstellas Pharma Global Development, Inc.
7 Previous Clinical Trials
923 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this research trial?

"At the present time, this clinical trial is not actively enrolling patients. Initially posted on August 22th 2019 and last edited November 23rd 2022, it is currently inactive. However, 18 studies targeting mucormycosis are accepting participants as well as 2 trials for Isavuconazonium sulfate."

Answered by AI

Is this experiment open to participants aged 25 and beyond?

"This trial is allowing for participation from youth aged between 1 year and 17 years."

Answered by AI

Am I eligible to partake in this research project?

"This clinical trial seeks 31 participants with mucormycosis between the ages of 1 and 17. The prerequisites are: a single serum or BAL value of ≥1.0, two separate GM values in serum at least 0.5 each, non-fertile patients or fertile ones agreeing to contraceptive guidance during treatment period and 30 days after drug administration; as well as commitment from patient (and parent/guardian) not to partake in any interventional studies except for oncology trials while receiving medication."

Answered by AI

How widely is this experiment being administered in the medical community?

"Fifteen medical centres across the country are partaking in this trial. For example, patients can find clinics operating in Orange, Washington and Miami as well as an additional dozen locations. To minimize travel stressors it is advisable to choose a clinic near you if you opt-in for the study."

Answered by AI

Is there still space available for volunteers to participate in this experiment?

"The information on clinicaltrials.gov suggests that this specific trial is no longer recruiting patients, with the initial post date being August 22nd 2019 and its most recent update occurring on November 23rd 2022. Despite this fact, there are 20 other trials open for enrolment right now."

Answered by AI

Has there been prior experimentation with Isavuconazonium sulfate?

"Isavuconazonium sulfate was first studied in 2019 at the renowned Ann & Robert H. Lurie Children's Hospital of Chicago and since then, 30 related trials have been completed with 2 currently active ones. Many are being conducted from Orange, California."

Answered by AI

Does this research represent a pioneering effort?

"Isavuconazonium sulfate was first trialled in 2019, under sponsorship from Astellas Pharma Global Development. After the successful Phase 1 study, involving 31 patients, Isavuconazonium sulfate received its drug approval for clinical trials at Level 2. Currently two studies are ongoing across 19 cities and 5 countries worldwide."

Answered by AI

Has Isavuconazonium sulfate earned the endorsement of U.S. Food and Drug Administration?

"As Isavuconazonium sulfate is in Phase 2 of testing, the safety rating was assessed to be a 2 due to limited evidence supporting efficacy."

Answered by AI

What goals is this research endeavor aiming to achieve?

"This 84-day study sets out to measure all-cause mortality within 42 days. The secondary objectives comprise assessing overall response through the end of treatment (EOT), mycological evidence of fungal disease at EOT, and evaluating clinical, mycological, and radiological responses up until day 84."

Answered by AI
~5 spots leftby Apr 2025