Covid 19 Research using Clinical Trials (Home Page)
Report for D001228: Aspergillosis NIH
(Synonyms: Aspergillosis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug551 | COVID-19 Therapeutic Vaccine - Nucleocapsid-GM-CSF Protein Lactated Ringer's Injection Wiki | 1.00 |
| drug1479 | Isavuconazonium sulfate Wiki | 0.50 |
Correlated MeSH Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009091 | Mucormycosis NIH | 0.71 |
| D055732 | Pulmonary Aspergillosis NIH | 0.71 |
| D001229 | Aspergillosis, Allergic Bronchopulmonary NIH | 0.71 |
| D020096 | Zygomycosis NIH | 0.71 |
| D009181 | Mycoses NIH | 0.50 |
| D003550 | Cystic Fibrosis NIH | 0.35 |
| D005355 | Fibrosis NIH | 0.27 |
| D003141 | Communicable Diseases NIH | 0.06 |
| D007239 | Infection NIH | 0.04 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 2 clinical trials
Clinical Trials
1 A Phase 2, Open-Label, Non-Comparative, Multicenter Study to Evaluate the Safety and Tolerability, Efficacy and Pharmacokinetics of Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Subjects
The purpose of this study is to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
NCT03816176 Invasive Mucormycosis Invasive Aspergillosis Drug: Isavuconazonium sulfate Drug: Isavuconazonium sulfate MeSH:Aspergillosis Mucormycosis Zygomycosis
Primary Outcomes
Description: An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Measure: Safety assessed by Adverse Events (AEs) Time: Up to 240 daysDescription: Number of participants with potentially clinically significant vital sign values
Measure: Number of participants with vital sign abnormalities and /or adverse events Time: Up to 84 daysDescription: A 12-lead, resting ECG will be recorded after participant has remained supine for at least 5 minutes. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded
Measure: Safety assessed by 12- lead electrocardiogram (ECG) Time: Up to 84 daysDescription: Number of participants with potentially clinically significant laboratory values
Measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs) Time: Up to 84 daysDescription: Each participant will be classified as either a death or alive
Measure: All-cause mortality through Day 42 Time: Up to 42 daysSecondary Outcomes
Description: Each participant will be classified as either a death or alive
Measure: All-cause mortality through Day 84 Time: Up to 84 daysDescription: Each participant will be classified as either a death or alive
Measure: All-cause mortality at End of Treatment (EOT) Time: Up to 180 daysDescription: Overall response through day 42 will be based on clinical, mycological, and radiological response
Measure: Overall response through Day 42 Time: Up to 42 daysDescription: Overall response through day 84 will be based on clinical, mycological, and radiological response
Measure: Overall response through Day 84 Time: Up to 84 daysDescription: Overall response through EOT will be based on clinical, mycological, and radiological response
Measure: Overall response at EOT Time: Up to 180 daysDescription: Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
Measure: Clinical response through Day 42 Time: Up to 42 daysDescription: Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
Measure: Clinical response through Day 84 Time: Up to 84 daysDescription: Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
Measure: Clinical response at EOT Time: Up to 180 daysDescription: Each participant will be assessed for radiological evidence of fungal disease
Measure: Radiological response through Day 42 Time: Up to 42 daysDescription: Each participant will be assessed for radiological evidence of fungal disease
Measure: Radiological response through Day 84 Time: Up to 84 daysDescription: Each participant will be assessed for radiological evidence of fungal disease
Measure: Radiological response at EOT Time: Up to 180 daysDescription: Each participant will be assessed for mycological evidence of fungal disease
Measure: Mycological response through Day 42 Time: Up to 42 daysDescription: Each participant will be assessed for mycological evidence of fungal disease
Measure: Mycological response through Day 84 Time: Up to 84 daysDescription: Each participant will be assessed for mycological evidence of fungal disease
Measure: Mycological response at EOT Time: Up to 180 daysDescription: Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected
Measure: Pharmacokinetics of isavuconazole in plasma: trough concentration (Ctrough) Time: Up to 84 days2 Immune Profiles in CF Fungal Infection
This study is investigating the role of allergic (Th2) inflammation in patients with Cystic Fibrosis (CF) and history of fungal infection and/or Allergic Bronchopulmonary Aspergillosis. Little is known about fungal infection in CF and conflicting results exist on whether this results in worse lung function over time. There is concern that persistent fungal infection can result in worse clinical outcome measures in patients with CF. Also, it is unclear how ABPA develops, but may be related to the amount of fungus a patient with CF is infected with. This study looks at inflammatory patterns and allergic responses to fungal elements to help identify biomarkers and signs of allergic disease in fungally infected patients with CF.
NCT04476758 Cystic Fibrosis Fungal Infection Allergic Bronchopulmonary Aspergillosis MeSH:Infection Communicable Diseases Mycoses Aspergillosis Pulmonary Aspergillosis Aspergillosis, Allergic Bronchopulmonary Cystic Fibrosis Fibrosis
Primary Outcomes
Description: Difference in sputum Th2 biomarkers (ECP, IL4, IL5, IL10, IL13, and eosinophil count) in patients with CF with fungal infection with expected elevation of sputum Th2 biomarkers in patients with CF and ABPA compared to those without fungal infection and without ABPA.
Measure: Difference in Th2 Sputum Markers Time: Average of 24 monthsSecondary Outcomes
Description: Serum Th2 biomarkers in patients with fungal infection and ABPA (Table 3). Serum Th1 biomarkers in patients with fungal infection and ABPA (Table 3). Serum sensitization markers to fungal allergens in patients with fungal infection and ABPA (Table 4). Baseline and historic lung function, historical comorbid diagnoses and BMI measurements in patients with fungal infection and ABPA. Environmental factors that are possibly related to fungal infection and ABPA in patients with CF. Immune profile: A profile of each group will be based upon their findings of each set of biomarkers: Th1, Th2, mold allergy panel, and systemic markers of inflammation. Based upon findings in each of these categories (elevated, depressed), we will be able to formulate a profile based upon the type of marker/inflammatory pathway.
Measure: Other markers of fungal inflammation and allergic reaction in patients with CF Time: Average of 24 monthsOther Outcomes
Description: Banking of both sputum and serum to potentially utilize microbiome and transcriptome techniques for further immunotyping and infection characterization.
Measure: Biobanking of specimens Time: Average of 24 months