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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-05159 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10087 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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The study was closed to accrual according to the Fred Hutch/University of Washington/Seattle Children's Consortium low accrual institutional policy.
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| Name | Class |
|---|---|
| Global Life Technologies Corp. | UNKNOWN |
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This phase I trial studies the side effects of Nozin in preventing respiratory viral infections in patients undergoing stem cell transplant. Nozin is a non-antibiotic, alcohol-based nasal sanitizer used in hospitals to prevent spread of bacterial infections and may also prevent community acquired respiratory virus infection in stem cell transplant recipients.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Beginning 7 days prior to transplant, patients receive Nozin via nasal single-use popswabs or single-use cotton tipped applicators and swab the inside of their nose two times daily (BID) up to 100 days after transplant.
ARM II: Patients receive standard of care.
After completion of study, patients are followed up every week for 6 weeks and then every alternate week until day 100.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Nozin) | Experimental | Beginning 7 days prior to transplant, patients receive Nozin via nasal single-use popswabs or single-use cotton tipped applicators and swab the inside of their nose BID up to 100 days after transplant. |
|
| Arm II (standard of care) | Active Comparator | Patients receive standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nozin | Drug | Given via nasal single-use popswabs or single-use cotton tipped applicators |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Nozin | Will measure and describe reasons for dropout, defined as failure to complete the study to day 100 for any reason. Among participants in the study product arm, reasons for dropout will be classified as either directly related to the product or due to other reasons. Will estimate the proportion of participants who exit the study for reasons directly related to the study product with a precision of +/- 20% (95% confidence interval) to inform tolerability of study product for future studies. Will compare dropout for any reason between treatment arms using Fisher's exact test. | Up to 100 days post-transplant |
| Incidence of adverse events (AEs) | AEs will be graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All adverse events will be continually monitored by the study team and descriptively compared between study arms. | Up to 100 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of community acquired respiratory viruses (CARV) | Will compare the cumulative incidence of CARV between study arms, counting death as a competing risk. Cox regression will be used to test for differences in the cause-specific hazard of CARV between study arms. | Up to 100 days post-transplant |
| Frequency of respiratory viral symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Pergam | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine-Orland Park | Orland Park | Illinois | 60462 | United States | ||
| Fred Hutch/University of Washington Cancer Consortium |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2019 | Nov 7, 2024 |
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| Best Practice | Other | Receive standard of care |
|
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Will use Poisson generalized estimating equation regression models to compare the frequency of respiratory viral symptoms between study arms |
| Up to 100 days post-transplant |
| Number of respiratory viral panel tests | Will compare the number of respiratory viral panel tests sent to the lab between study arms using Poisson regression with an offset for the number of days each participant was in the study. | Up to 100 days post-transplant |
| Seattle |
| Washington |
| 98109 |
| United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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