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

Last updated: November 7, 2024
Sponsor: Fred Hutchinson Cancer Center
Overall Status: Terminated

Phase

1

Condition

Neoplasms

Treatment

Best Practice

Nozin

Clinical Study ID

NCT04060849
RG1004525
10087
NCI-2019-05159
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Undergoing allogeneic hematopoietic transplant for malignant or non-malignantdisease

  • English speaking

  • Capable of providing informed consent

  • Planned to receive follow-up at the transplant site for the first 100 days posttransplantation

  • Subjects who the investigator believes can and will comply with the study protocol

Exclusion

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, lauricacid, 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 skininvolving the nose or nasal vestibule

  • Daily use of nasal decontamination products or other nasal medications (e.g. nasalsteroids)

  • Unable to complete study procedures (e.g. nasal swab self-testing)

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Best Practice
Phase: 1
Study Start date:
September 03, 2019
Estimated Completion Date:
April 12, 2020

Study 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 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.

Connect with a study center

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois 60462
    United States

    Site Not Available

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington 98109
    United States

    Site Not Available

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