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
- Conditions
- Parainfluenza
- Interventions
- Drug: DAS181 dry powder, formulation F02
- Registration Number
- NCT01644877
- Lead Sponsor
- Ansun Biopharma, Inc.
- Brief Summary
This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen and diagnosed with a parainfluenza infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- Age ≥12 years
- 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.
- Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DAS181 DAS181 dry powder, formulation F02 DAS181-F02, 4.5 mg qd x 10 days Lactose Placebo Lactose Placebo placebo, 4.5 mg qd x 10 days
- Primary Outcome Measures
Name Time Method Clinical Stability 45 days Clinical stability survival (CSS) rate is defined as subjects who meet the clinical stability criteria and are alive at Study Day 45 (Responders) compared to those who have not met clinical stability criteria or have expired regardless of stability status (Non-responders)
- Secondary Outcome Measures
Name Time Method Clinical Stability 45 days Time (in days) to hospital discharge of CS non-responders and death
Mortality 45 days Mortality rate at Day 45
Trial Locations
- Locations (45)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Lurie Children's Hospital
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
City of Hope
🇺🇸Duarte, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Ansun Biopharma, Inc
🇺🇸San Diego, California, 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
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
Nationwide Children's
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Virginia Commonwealth
🇺🇸Richmond, Virginia, United States
Fred Hutchinson Cencer Research Center
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Children's Mercy Hospital
🇺🇸Kansas City, Kansas, United States
University of Minnesota, School of Medicine
🇺🇸Minnesota City, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Mayo Clinic-Arizona
🇺🇸Phoenix, Arizona, United States
UC Davis
🇺🇸Sacramento, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbilt- Henry-Joyce Cancer Clinic
🇺🇸Nashville, Tennessee, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
John Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Montefiore Medical Center
🇺🇸The Bronx, New York, United States