Status:
WITHDRAWN
DAS181 in Patients With Parainfluenza
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Parainfluenza Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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). S...
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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 18 years
- Positive culture, DFA, PCR or other clinical assay for parainfluenza
- Symptomatic upper or lower respiratory tract disease (e.g., pharyngitis, cough, tracheobronchitis, bronchiolitis, pneumonia). Fever alone is not sufficient.
- Onset of illness within the last 10 days
- 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
- Willingness to have samples stored
- EXCLUSION CRITERIA:
- Known hypersensitivity to DAS181 or any of its components
- Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding
- Mechanical ventilation, acute respiratory distress, or otherwise unable to tolerate the drug delivery device (Cyclohaler)
- Allergy or history of allergy to milk or lactose
- Previous or current history of asthma or chronic obstructive pulmonary disease (COPD) requiring daily medication
- 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
Exclusion
Key Trial Info
Start Date :
July 14 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01441024
Start Date
July 14 2011
End Date
June 30 2014
Last Update
December 17 2019
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