A Phase II, Randomized, Double-blind, Placebo-controlled Study to Examine the Effects of DAS181 in Immunocompromised Subjects With Lower Respiratory Tract Parainfluenza Infection on Supplemental Oxygen
NCT ID: NCT01644877
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2014-03-31
2016-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DAS181
DAS181-F02, 4.5 mg qd x 10 days
DAS181 dry powder, formulation F02
Lactose Placebo
placebo, 4.5 mg qd x 10 days
Lactose Placebo
Interventions
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DAS181 dry powder, formulation F02
Lactose Placebo
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent, child assent with parental consent or surrogate consent when applicable
* Currently on invasive mechanical ventilation or noninvasive positive pressure ventilation (CPAP or bilevel positive airway pressure) or requiring \> 2LPM supplemental oxygen therapy to maintain O2 saturation \> 90% due to hypoxemia
* Immunocompromised, as defined by one of the following: Autologous or Allogeneic hematopoietic cell transplantation (HSCT); Lung or lung-heart transplantation; Subjects treated with chemotherapy for hematologic malignancies; Subjects treated with chemotherapy for solid tumor malignancies
* Confirmed parainfluenza at screening by one of the following methods using any sample type: Respiratory Virus Panel, Direct fluorescent antibody (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).
* Confirmed PIV lower tract disease for subjects on mechanical ventilation will be defined as PIV detection in bronchoalveolar lavage (BAL) or biopsy within last 7 days of screening
* Confirmed PIV lower tract disease for subjects on non-invasive positive pressure ventilation or supplemental oxygen will be defined as all of the following within the last 7 days of screening: New pulmonary infiltrate on chest imaging and at least one PIV sign and/or symptom as defined in section 10.3.6
* 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 abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ≥18 years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period. All reproductive female subjects must have a negative serum pregnancy test during the screening visit.
* Male subjects must agree to use medically accepted form of contraception during the study period. Abstinence is an acceptable method of contraception.
Exclusion Criteria
* Any significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule.
* In the opinion of the Investigator, subjects with a low chance of survival during the first 5 days of treatment.
* Subjects treated with oral, aerosolized or intravenous (IV) ribavirin for the treatment of PIV. A forty-eight hour (48 hr) wash out period prior to randomization is allowed.
* Subjects with a history of RSV or MPV
* Subjects taking any other investigational drug used to research or treat PIV.
* Subjects with a history of allergic reactions to lactose.
* Subjects with a history of documented Pseudomonas aeruginosa pneumonia confirmed radiographically and by culture from BAL.
12 Years
ALL
No
Sponsors
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Ansun Biopharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic-Arizona
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Children's Hospital of Orange County
Orange, California, United States
Stanford University Medical Center
Palo Alto, California, United States
UC Davis
Sacramento, California, United States
Ansun Biopharma, Inc
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Lurie Children's Hospital
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Children's Mercy Hospital
Kansas City, Kansas, United States
University of Kansas
Kansas City, Kansas, United States
John Hopkins University School of Medicine
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota, School of Medicine
Minnesota City, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, United States
Weill Cornell Medical College-Peds
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Stonybrook
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt- Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Fred Hutchinson Cencer Research Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Chemaly RF, Marty FM, Wolfe CR, Lawrence SJ, Dadwal S, Soave R, Farthing J, Hawley S, Montanez P, Hwang J, Ho JH, Lewis S, Wang G, Boeckh M. DAS181 Treatment of Severe Lower Respiratory Tract Parainfluenza Virus Infection in Immunocompromised Patients: A Phase 2 Randomized, Placebo-Controlled Study. Clin Infect Dis. 2021 Aug 2;73(3):e773-e781. doi: 10.1093/cid/ciab113.
Other Identifiers
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DAS181-2-05
Identifier Type: -
Identifier Source: org_study_id