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DAS181 in Patients With Parainfluenza

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ClinicalTrials.gov Identifier: NCT01441024
Recruitment Status : Withdrawn
First Posted : September 27, 2011
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

September 24, 2011
September 27, 2011
July 16, 2018
July 14, 2011
February 27, 2014   (Final data collection date for primary outcome measure)
Number patients with at least 1 grade 3/4/SAE that are possibly, probably, or definitely related to the study product by Study Day 28. [ Time Frame: study day 28 ]
Same as current
Complete list of historical versions of study NCT01441024 on ClinicalTrials.gov Archive Site
  • Virologic Endpoints: Viral shedding by qualitative PCR or culture. [ Time Frame: 1 year ]
  • Clinical Endpoints: Clinical symptoms, Fever, Radiographic evidence of lower tract disease by CT (if obtained clinically), Death, Hospitalization, Use of supplemental oxygen. [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
DAS181 in Patients With Parainfluenza
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of DAS181 in Patients With Parainfluenza Infection

Background:

- Parainfluenza is a virus that can cause infections in people. Most people infected with this virus have mild symptoms including fever, cough, red eyes, or runny nose (a common cold). Some people, especially those with a weakened immune system, get very sick from this virus. They may have difficulty breathing or develop lung infections. Currently, there are no specific treatments for parainfluenza. However, a drug called DAS181 may make the virus go away faster. Researchers are interested in testing DAS181 to see if it is safe and effective against parainfluenza.

Objectives:

- To test the safety and effectiveness of DAS181 as a treatment for parainfluenza.

Eligibility:

- Individuals at least 18 years of age who have the parainfluenza virus and have developed symptoms within the past 10 days.

Design:

  • Participants will be screened with a physical exam, medical history, and questions about symptoms and activity levels. Participants will also have a lung function test and provide blood and nasal fluid samples.
  • DAS181 is an inhaled medication, and everyone will receive a study medication inhaler. Participants will receive either DAS181 or a placebo through the inhaler. They will take it once every day for 5 days.
  • Participants will have monitoring visits on days 2, 4, 7, 10, 14, and 28 to provide blood and nasal fluid samples and have a lung function test.
  • Participants who still have the virus in their system on Day 28 will return to the clinic on Day 42 for more tests. Participants who still have the virus in their system on Day 42 will return to the clinic on Day 56 for more tests.
  • Participants will have followup visits 6 months and 1 year after the start of the study.

Parainfluenza virus (PIV) infections cause considerable morbidity in the immunocompromised population. In the immunocompetent population, PIV is usually self-limited, but can cause more severe disease including pneumonia and tracheobronchitis in adults, and croup and bronchiolitis in young children. DAS181, an inhaled sialidase, cleaves the binding site of PIV from respiratory mucosal cells limiting the ability of PIV to infect new cells. This may improve outcomes in patients with PIV infections.

This exploratory randomized double-blind Phase 2 study will assess the safety and tolerability, and explore the efficacy of DAS181 versus placebo for the treatment of parainfluenza. Thirty eligible patients diagnosed with parainfluenza will be randomized in a 2:1 allocation to receive either DAS181-F02 formulation (10 mg times 5 days) or placebo. Subjects will be followed on Study Days 0, 2, 4, 7, 10, 14, 28, 180, and 365 with a series of clinical, pulmonary function, functional status, virologic, and safety assessments.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Parainfluenza Infection
  • Drug: DAS181
    20 mg per day of DAS181-FO3 for 5 days
  • Other: Placebo
    20 mg per day of Lactose for 5 days
  • Experimental: 1
    DAS181
    Intervention: Drug: DAS181
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
50
June 30, 2014
February 27, 2014   (Final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

    1. Age greater than or equal to 18 years
    2. Positive culture, DFA, PCR or other clinical assay for parainfluenza
    3. Symptomatic upper or lower respiratory tract disease (e.g., pharyngitis, cough, tracheobronchitis, bronchiolitis, pneumonia). Fever alone is not sufficient.
    4. Onset of illness within the last 10 days
    5. Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception from the date of informed consent through Study Day 28 of the study. At least 1 of the methods of contraception should be a barrier method
    6. Willingness to have samples stored

EXCLUSION CRITERIA:

  1. Known hypersensitivity to DAS181 or any of its components
  2. Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding
  3. Mechanical ventilation, acute respiratory distress, or otherwise unable to tolerate the drug delivery device (Cyclohaler)
  4. Allergy or history of allergy to milk or lactose
  5. Previous or current history of asthma or chronic obstructive pulmonary disease (COPD) requiring daily medication
  6. Any significant findings 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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01441024
110205
11-I-0205
Not Provided
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Richard T Davey, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
February 27, 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP