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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Aspergillosis is a chronic infection in patients with lung [transplant](https://www.withpower.com/clinical-trials/transplant)s 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.