Protocol

DASRAN: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of DAS181 in Immunocompromied Subjects with Lower Respiratory Tract ParaInfluenza (PIV) Infection on Supplemental Oxygen

Diseases

Infectious Diseases : Parainfluenza virus in immunocompromised patients


Description

Currently there are no medications approved for the treatment of parainfluenza virus infection (PIV), including no effective treatment for PIV infection for the immunocompromised population (including persons undergoing autologous or allogeneic hematopoietic cell transplant, lung or heart-lung transplant, patients treated with chemotherapy for hematologic malignancies or solid organ malignancies) outside of supportive care (supplemental oxygen, corticosteroids, antibiotics). The purpose of this research study is to test the safety, effectiveness and tolerability of an investigational drug called DAS181 on study participants with a very weak immune system who are diagnosed with a PIV infection. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). DAS181 will be given as a liquid aerosol spray using a nebulizer (a device used to turn liquids into mist for breathing treatments).

Because this is a research study, DAS181 will be given to you only during this study and not after the study is over.


Objectives

Primary

Secondary

Eligibility criteria, among others, include:

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).


Contact

Ashok Srinivasan, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
FAX: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.