Parainfluenza InfectionPhase 2NCT01441024
DAS181 in Patients With Parainfluenza
A Phase 2 study testing DAS181 in people with Parainfluenza Infection, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial 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). Some people, especially those with a weakened immune system, get very sick from this virus. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parainfluenza Infection
- What is being tested?
- DAS181
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Jul 2011to 30 Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Parainfluenza Infection
- Being tested
- DAS181, Placebo
- Keywords
- Immunocompromised, Respiratory Tract Disease, Viral Shedding, Fever, Pharmacokinetics, Parainfluenza Infection, Flu
- Medical subject headings
- Paramyxoviridae Infections, Respiratory Tract Diseases, Fever, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181Drug
20 mg per day of DAS181-FO3 for 5 days
PlaceboOther
20 mg per day of Lactose for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DAS181 Receives: Drug: DAS181 |
| 2 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: study day 28
Secondary outcomes (2)
Virologic Endpoints: Viral shedding by qualitative PCR or culture.
Measured: 1 year
Clinical Endpoints: Clinical symptoms, Fever, Radiographic evidence of lower tract disease by CT (if obtained clinically), Death, Hospitalization, Use of supplemental oxygen.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study start14 Jul 2011
- Primary completion27 Feb 2014
- Study completion30 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parainfluenza InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard T Davey, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441024
- Sponsor's protocol ID
- 110205
- Other IDs
- 11-I-0205
- Status last verified
- 27 Feb 2014
- First submitted
- 24 Sep 2011
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Henrickson KJ. Parainfluenza viruses. Clin Microbiol Rev. 2003 Apr;16(2):242-64. doi: 10.1128/CMR.16.2.242-264.2003.
PubMed 12692097Weintrub 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.
PubMed 3034189Apalsch 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. doi: 10.1093/clinids/20.2.394.
PubMed 7742447
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Study of DAS181 in Patients With Parainfluenza Infection
- ClinicalTrials.gov ID
- NCT01441024
- Acronym / sponsor ID
- 110205
- Conditions
- Parainfluenza Infection
- Keywords
- Immunocompromised, Respiratory Tract Disease, Viral Shedding, Fever, Pharmacokinetics, Parainfluenza Infection, Flu
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 14 Jul 2011
- Primary completion
- 27 Feb 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DAS181DAS181 |
| 2 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAS18120 mg per day of DAS181-FO3 for 5 days | Drug | 1 |
| Placebo20 mg per day of Lactose for 5 days | Other | 2 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 12692097Henrickson KJ. Parainfluenza viruses. Clin Microbiol Rev. 2003 Apr;16(2):242-64. doi: 10.1128/CMR.16.2.242-264.2003.
- Background: PubMed 3034189Weintrub 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.
- Background: PubMed 7742447Apalsch 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. doi: 10.1093/clinids/20.2.394.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Davey, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAS181 in people with Parainfluenza Infection, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01441024, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.