Isavuconazonium sulfate for Aspergillosis

Phase-Based Estimates
Children's Hospital of Orange County, Orange, CA
Aspergillosis+4 More
Isavuconazonium sulfate - Drug
< 18
All Sexes
Eligible conditions

Study Summary

This study is evaluating whether a drug may help treat children with a certain type of leukemia.

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Eligible Conditions

  • Aspergillosis
  • Mucormycosis
  • Zygomycosis
  • Invasive Mucormycosis
  • Invasive Aspergillosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Isavuconazonium sulfate will improve 5 primary outcomes and 15 secondary outcomes in patients with Aspergillosis. Measurement will happen over the course of Up to 42 days.

Up to 180 days
All-cause mortality at End of Treatment (EOT)
Clinical response at EOT
Mycological response at EOT
Overall response at EOT
Radiological response at EOT
Up to 240 days
Safety assessed by Adverse Events (AEs)
Up to 42 days
All-cause mortality through Day 42
Clinical response through Day 42
Mycological response through Day 42
Overall response through Day 42
Radiological response through Day 42
Up to 84 days
All-cause mortality through Day 84
Clinical response through Day 84
Mycological response through Day 84
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with vital sign abnormalities and /or adverse events
Overall response through Day 84
Pharmacokinetics of isavuconazole in plasma: trough concentration (Ctrough)
Radiological response through Day 84
Safety assessed by 12- lead electrocardiogram (ECG)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Isavuconazonium sulfate

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Isavuconazonium Sulfate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Isavuconazonium sulfate
Participants will receive a loading dose of isavuconazonium sulfate (via intravenous or oral administration at the investigator's discretion) every 8 hours (± 2 hours) on Days 1 and 2 followed by once-daily maintenance dosing
ControlNo treatment in the control group
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 240 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 240 days for reporting.

Closest Location

Children's Hospital of Orange County - Orange, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Proven, probable or possible IFI per the European Organisation for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG], 2008 criteria Note: Subjects with "possible" IFI will be eligible for enrollment; however, diagnostic tests to confirm the invasive fungal disease as "probable" or "proven" according to the EORTC/MSG criteria should be completed within 10 calendar days after the first dose of study drug
1. A single value for serum or bronchoalveolar lavage (BAL) fluid of ≥ 1.0 or 2. Two serum GM values of ≥ 0.5 from two separate samples
Subject has sufficient venous access to permit intravenous administration of study drug or the ability to swallow oral capsules
Not a subject who is of childbearing potential, OR Subject who is of childbearing potential who agrees to follow a contraceptive guidance throughout the treatment period and for at least 30 days after the final study drug administration
Subject and subject's parent(s) or legal guardian agree that the subject will not participate in another interventional study while on treatment with the exception of oncology trials

Patient Q&A Section

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

What are common treatments for aspergillosis?

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Aspergillosis treatment is largely dictated by the underlying infection in question. These treatment regimens can be difficult to determine by themselves and require an evaluation by a medical specialist knowledgeable in the management of fungal infections.

Unverified Answer

How many people get aspergillosis a year in the United States?

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It is estimated that 10-20% of the general population dies annually from invasive aspergillotic infections. Aspergillosis is a significant, and growing, cause of morbidity and mortality in hospitalized patients. Understanding the incidence should help develop methods to mitigate the burden of aspergillosis.

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What are the signs of aspergillosis?

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Early symptoms including cough and wheezing are the most common initial presentation. Complications include airway obstruction with rapid respiratory failure, septic shock, and pulmonary hemorrhage. Patients with underlying medical illnesses (particularly lung disease) who present with symptoms consistent with invasive aspergillosis should be suspected of having this disorder, even in the absence of anemia. Scedema is a less specific sign, and further workup may be indicated.

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Can aspergillosis be cured?

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Aspergillosis, as well as other fungal infections, can be cured using antimycotic drug therapy combined with effective antifungal prophylactic therapy and surgical intervention. The combination of surgery and antifungal treatment is highly effective and may save a patient's life. Patients who require prolonged anti-fungal therapy should be monitored intensely to ensure that a return of symptomatic fungal pneumonia does not occurrence.

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What causes aspergillosis?

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The diagnosis of aspergillosis is most often made in hospitalized patients with acute or chronic lung disease, and the vast majority of these cases are suspected to derive from colonization with airborne inhaled particles rather than from infection with pathogenic fungi. We review the current concepts and treatments of the most clinically significant species of aspergillosis. In a recent study, findings show that empiric therapy with antifungal drugs is a safe and cost-effective approach to avoiding invasive procedures and providing treatment for aspergillosis.

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What is aspergillosis?

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Aspergillus is a ubiquitous and often misdiagnosed mold fungus. It is the most common fungal organism causing invasive aspergillosis in immunocompromised hosts (pancreas, bronchoalveolar lavage, liver, etc.). Effective prevention of fungal infection is possible only with antifungal agents (e.g., amphotericin B) and timely identification of fungal infection. Aspergilloma is an important form of aspergillosis, which occurs in immunocompromised hosts as a complication of disseminated fungal infection (disseminated aspergillosis). As peritonitis may also occur in immunocompromised patients.

Unverified Answer

Is isavuconazonium sulfate typically used in combination with any other treatments?

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Although it can be used as salvage therapy for severe disease in patients with a high risk of death, isavuconazonium has limited effectiveness in terms of clinical response and survival and is usually ineffective in case of treatment failure or resistance to it. Its effectiveness was better than that of amphotericin B as salvage therapy for severe disease.

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Has isavuconazonium sulfate proven to be more effective than a placebo?

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Isavuconazonium sulfate demonstrates effectiveness similar both overall and specifically for patients with aspergillus pneumonia, in combination with oral and intravenous antifungals. Oral voriconazole alone shows limited effectiveness; however, voriconazole is the only treatment in current clinical trials to be as effective or more effective than inhaled isavuconazonium sulfate. Isovuconazonium sulfate should be considered a viable treatment option for patients with aspergillus pneumonia, and voriconazole should be the first-line antifungal treatment, when inhaled isavuconazonium sulphate is unavailable.

Unverified Answer

How does isavuconazonium sulfate work?

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There is not enough evidence to prove that isavuconazonium sulfate, when used intravenously, improves outcome in patients with sepsis caused by the mold fungus Aspergillus. The same may be said for ceftazidime or meropenem.

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Does aspergillosis run in families?

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The finding that there is no increased risk of colonization with Aspergillus spp., or infection with A. fumigatus in people with familial cases warrants further investigation. Further investigation is indicated, with the hope that this may allow identification of a genetic risk factor that predisposes to clinical aspergillosis.

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Have there been any new discoveries for treating aspergillosis?

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Although a multitude of antifungal drugs exist, only 1 % to 5 % are effective. Currently available treatments are highly toxic, and the development of novel agents is needed.

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What is the latest research for aspergillosis?

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Aspergillosis is a chronic infection in patients with lung [transplant]( and those with weakened immune systems, and it is a global health concern. The pathogenesis of aspergillosis is relatively clear, but its diagnosis and treatment remain challenging. Although the incidence and mortality of aspergillosis is low, the mortality rate has been increasing recently; this is an urgent and important global issue for health professionals.

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