Parainfluenza Infection Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of DAS181 in Patients With Parainfluenza Infection
| Verified date | February 27, 2014 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 30, 2014 |
| Est. primary completion date | February 27, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
- 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) |
Apalsch AM, Green M, Ledesma-Medina J, Nour B, Wald ER. Parainfluenza and influenza virus infections in pediatric organ transplant recipients. Clin Infect Dis. 1995 Feb;20(2):394-9. — View Citation
Henrickson KJ. Parainfluenza viruses. Clin Microbiol Rev. 2003 Apr;16(2):242-64. Review. — View Citation
Weintrub PS, Sullender WM, Lombard C, Link MP, Arvin A. Giant cell pneumonia caused by parainfluenza type 3 in a patient with acute myelomonocytic leukemia. Arch Pathol Lab Med. 1987 Jun;111(6):569-70. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | study day 28 | ||
| Secondary | Virologic Endpoints: Viral shedding by qualitative PCR or culture. | 1 year | ||
| Secondary | Clinical Endpoints: Clinical symptoms, Fever, Radiographic evidence of lower tract disease by CT (if obtained clinically), Death, Hospitalization, Use of supplemental oxygen. | 1 year |