Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 126 for:    "Viral Infectious Disease" | "Ethanol"

Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04060849
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Global Life Technologies Corp.
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Viral Upper Respiratory Tract Infection Allogeneic Bone Marrow Transplantation Recipient Drug: Nozin Other: Best Practice Phase 1

Detailed Description:

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 three times daily (TID) 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Respiratory Viruses Using Nozin in Stem Cell Transplant Recipients (PREV-NOSE Study)
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Arm Intervention/treatment
Experimental: Arm I (Nozin)
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 TID up to 100 days after transplant.
Drug: Nozin
Given via nasal single-use popswabs or single-use cotton tipped applicators
Other Names:
  • Ethanol-based Intranasal Solution
  • Ethanol-based Nasal Sanitizer
  • Ethanol-containing Nasal Solution

Active Comparator: Arm II (standard of care)
Patients receive standard of care.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy




Primary Outcome Measures :
  1. Tolerability of Nozin [ Time Frame: Up to 100 days post-transplant ]
    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.

  2. Incidence of adverse events (AEs) [ Time Frame: Up to 100 days post-transplant ]
    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.


Secondary Outcome Measures :
  1. Incidence of community acquired respiratory viruses (CARV) [ Time Frame: Up to 100 days post-transplant ]
    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.

  2. Frequency of respiratory viral symptoms [ Time Frame: Up to 100 days post-transplant ]
    Will use Poisson generalized estimating equation regression models to compare the frequency of respiratory viral symptoms between study arms

  3. Number of respiratory viral panel tests [ Time Frame: Up to 100 days post-transplant ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing allogeneic hematopoietic transplant for malignant or non-malignant disease
  • English speaking
  • Capable of providing informed consent
  • Planned to receive follow-up at the transplant site for the first 100 days post transplantation
  • Subjects who the investigator believes can and will comply with the study protocol

Exclusion Criteria:

  • Documented respiratory viral infection in the two weeks prior to enrollment
  • Current or planned use of any prophylactic antiviral therapy, antibody treatments, or other agents targeting the prevention of respiratory viruses (i.e. oseltamivir, ribavirin, amantadine)
  • Known allergy to study drug components (jojoba, orange oil, coconut oil, lauric acid, benzalkonium chloride, vitamin E)
  • Receiving oxygen supplementation at time of enrollment
  • Active mucositis at time of enrollment
  • Ongoing irritation or active infection of the squamous epithelial cell skin involving the nose or nasal vestibule
  • Daily use of nasal decontamination products or other nasal medications (e.g. nasal steroids)
  • Unable to complete study procedures (e.g. nasal swab self-testing)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060849


Contacts
Layout table for location contacts
Contact: Sara Marquis 206.667.2100 smarquis@fredhutch.org

Locations
Layout table for location information
United States, Illinois
University of Chicago Medicine-Orland Park Not yet recruiting
Orland Park, Illinois, United States, 60462
Contact: Kathleen Mullane    773-702-6119    kmullane@medicine.bsd.uchicago.edu   
Principal Investigator: Kathleen Mullane         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Sara Marquis    206-667-2100    smarquis@fredhutch.org   
Principal Investigator: Steven Pergam         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Global Life Technologies Corp.
Investigators
Layout table for investigator information
Principal Investigator: Steven Pergam Fred Hutch/University of Washington Cancer Consortium

Layout table for additonal information
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT04060849     History of Changes
Other Study ID Numbers: RG1004525
NCI-2019-05159 ( Registry Identifier: NCI / CTRP )
10087 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Respiratory Tract Infections
Respiratory Tract Diseases
Ethanol
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs