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DAS181 in Patients With Parainfluenza

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01441024
First received: September 24, 2011
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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....

Condition Intervention Phase
Parainfluenza Infection
Drug: DAS181
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of DAS181 in Patients With Parainfluenza Infection

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Virologic Endpoints: Viral shedding by qualitative PCR or culture. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DAS181
Drug: DAS181
20 mg per day of DAS181-FO3 for 5 days
Placebo Comparator: 2
Placebo
Other: Placebo
20 mg per day of Lactose for 5 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441024

Sponsors and Collaborators
Investigators
Principal Investigator: Richard T Davey, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01441024     History of Changes
Other Study ID Numbers: 110205, 11-I-0205
Study First Received: September 24, 2011
Last Updated: February 28, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Immunocompromised
Respiratory Tract Disease
Viral Shedding
Fever
Pharmacokinetics
Parainfluenza Infection
Flu

Additional relevant MeSH terms:
Communicable Diseases
Infection
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014