An Open Label Study to Examine the Effects of DAS181 Administered by Dry Powder Inhaler (DPI) or Nebulized Formulation in Immunocompromised Subjects With Parainfluenza (PIV) Infection

Overview

About this study

This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with parainfluenza infection.

All subjects will have additional PK and Immunogenicity blood samples collected.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Age ≥12 years
  2. Able to provide informed consent or child assent with parental consent
  3. Immunocompromised, as defined by one of the following:
    • Allogeneic hematopoietic cell transplantation (HCT)
    • Lung or lung-heart transplantation
    • Patients treated with chemotherapy for hematologic malignancies or autologous HCT
  4. Confirmed Parainfluenza virus by nasopharyngeal swab or tracheal aspirate for one of the following:
    • Respiratory virus panel
    • DFA
    • Qualitative/quantitative RT-PCR test for parainfluenza virus performed at the local laboratory (a confirmatory PCR test will be done at the central lab but is not required to start the patient on study).
  5. Female subjects of child-bearing potential who are capable of conception must be: post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject must agree to practice two acceptable methods of birth control during the 28 day study period. Abstinence is not an acceptable method of contraception. All reproductive female subjects must have a negative serum pregnancy test during the screening visit.
  6. Male subjects must agree to use medically accepted form of contraception during the 28 day study period.

Exclusion Criteria:

  1. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
  2. Any significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety, ability to use the dry powder inhaler or compliance with the dosing schedule.
  3. Subjects currently treated with oral, aerosolized or IV ribavirin
  4. Subjects taking any investigational drug used to research or treat PIV

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Roberto Patron, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
.
CLS-20145061

Mayo Clinic Footer