Respiratory Syncytial Virus InfectionsNCT01754428
Surveillance Study of Respiratory Syncytial Virus Infection (RSV) in Subjects < 24 Months of Age
An observational study of Respiratory Syncytial Virus Infections, run by Gilead Sciences at 15 sites in United States.
Trial summary
The purpose of this study is to collect clinical outcome and nasal viral load information. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- How many people
- 2,432 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2012to May 2013
- Phase
- Observational
- 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 Up to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Outpatient pediatric clinics, urgent care facilities or emergency departments
Who may be able to join
- < 24 months of age
- ≥ 35 weeks gestational age at birth
- Signs of acute Respiratory Tract Infection < 5 days
- Ability to contact parent or legal guardian for follow up
Who cannot join
- Ongoing Respiratory Tract Infection
- Lung disease
- Heart disease
- Respiratory Syncytial Virus medication in the last 6 months
- Participation in a study with investigational medicinal product in the last 28 days
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
University of Alabama at Birmingham
Birmingham, Alabama, 35223
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital, The Ohio State University College of Medicine
Columbus, Ohio, 43205
University of Colorado Denver/Children's Hospital Colorado
Denver, Colorado, 80045
Baylor College of Medicine
Houston, Texas, 77030
Children's Mercy Hospital & Clinics
Kansas City, Missouri, 64108
Arkansas Children's Hospital/University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
Pediatrics & Adolescent Medicine, P.A.
Marietta, Georgia, 30062
University of Tennessee
Memphis, Tennessee, 38103
Vanderbilt University
Nashville, Tennessee, 37232
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Seattle Children's Hospital
Seattle, Washington, 98105
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
Official title: A Multi-Center, Outpatient, Surveillance Study of Respiratory Syncytial Virus (RSV) Infection and Respiratory Syncytial Virus-related Hospitalizations Among Subjects < 24 Months of Age With a Medically Attended Respiratory Tract Infection
The purpose of this study is to collect clinical outcome and nasal viral load information.
Read the detailed description
There is no vaccine available to prevent Respiratory Syncytial Virus disease; however, a humanized monoclonal antibody is approved for the prevention of Respiratory Syncytial Virus infection in pediatric patients at high risk of disease (eg, pre-term infants, congenital heart disease, and chronic lung disease). Beyond this high-risk group, infection is common in otherwise healthy infants and can be severe, leading to hospitalization and while uncommon, death. Each year in the United States, approximately 100,000 Respiratory Syncytial Virus-related hospitalizations occur in low risk infants. Currently, treatment of infants suffering from Respiratory Syncytial Virus disease is limited to supportive care with the goal of maintaining adequate oxygenation and nutrition.
The availability of a novel anti-Respiratory Syncytial Virus therapeutic that reduces the number of hospitalizations related to Respiratory Syncytial Virus infection would fulfill an unmet medical need in the pediatric population. For maximum effect, such a treatment should be administered as early as possible in the course of infection. Accordingly, the opportunities for early intervention with an anti-Respiratory Syncytial Virus therapeutic are in the outpatient setting, prior to hospitalization. However, the incidence of Respiratory Syncytial Virus-related hospitalization, as well as the natural history and viral dynamics of Respiratory Syncytial Virus infection, remain undefined in the outpatient setting. A better understanding of the prevalence of Respiratory Syncytial Virus infection and subsequent hospitalization rates among symptomatic infants as well as the early disease course of Respiratory Syncytial Virus infection will help in the design of clinical trials needed to assess the efficacy of an anti-Respiratory Syncytial Virus therapeutic developed by Gilead Sciences.
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory, Syncytial, Virus, RSV
- Medical subject headings
- Respiratory Syncytial Virus Infections, Virus Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms
Measured: Up to seven months
Secondary outcomes (1)
Percentage of Respiratory Syncytial Virus-positive subjects who sought medical attention, as a result of the Respiratory Tract Infection, after Visit 1
Measured: Up to seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John DeVincenzo, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754428
- Sponsor's protocol ID
- GS-US-218-0111
- Status last verified
- Aug 2013
- First submitted
- 7 Dec 2012
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Outpatient, Surveillance Study of Respiratory Syncytial Virus (RSV) Infection and Respiratory Syncytial Virus-related Hospitalizations Among Subjects < 24 Months of Age With a Medically Attended Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT01754428
- Acronym / sponsor ID
- GS-US-218-0111
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory, Syncytial, Virus, RSV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,432 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Dec 2012 (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.
The purpose of this study is to collect clinical outcome and nasal viral load information.
Detailed description
There is no vaccine available to prevent Respiratory Syncytial Virus disease; however, a humanized monoclonal antibody is approved for the prevention of Respiratory Syncytial Virus infection in pediatric patients at high risk of disease (eg, pre-term infants, congenital heart disease, and chronic lung disease). Beyond this high-risk group, infection is common in otherwise healthy infants and can be severe, leading to hospitalization and while uncommon, death. Each year in the United States, approximately 100,000 Respiratory Syncytial Virus-related hospitalizations occur in low risk infants. Currently, treatment of infants suffering from Respiratory Syncytial Virus disease is limited to supportive care with the goal of maintaining adequate oxygenation and nutrition.
The availability of a novel anti-Respiratory Syncytial Virus therapeutic that reduces the number of hospitalizations related to Respiratory Syncytial Virus infection would fulfill an unmet medical need in the pediatric population. For maximum effect, such a treatment should be administered as early as possible in the course of infection. Accordingly, the opportunities for early intervention with an anti-Respiratory Syncytial Virus therapeutic are in the outpatient setting, prior to hospitalization. However, the incidence of Respiratory Syncytial Virus-related hospitalization, as well as the natural history and viral dynamics of Respiratory Syncytial Virus infection, remain undefined in the outpatient setting. A better understanding of the prevalence of Respiratory Syncytial Virus infection and subsequent hospitalization rates among symptomatic infants as well as the early disease course of Respiratory Syncytial Virus infection will help in the design of clinical trials needed to assess the efficacy of an anti-Respiratory Syncytial Virus therapeutic developed by Gilead Sciences.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Outpatient pediatric clinics, urgent care facilities or emergency departments
Key inclusion criteria (4 listed)
- < 24 months of age
- ≥ 35 weeks gestational age at birth
- Signs of acute Respiratory Tract Infection < 5 days
- Ability to contact parent or legal guardian for follow up
Key exclusion criteria (5 listed)
- Ongoing Respiratory Tract Infection
- Lung disease
- Heart disease
- Respiratory Syncytial Virus medication in the last 6 months
- Participation in a study with investigational medicinal product in the last 28 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms
Time frame: Up to seven months
1 secondary outcome
Percentage of Respiratory Syncytial Virus-positive subjects who sought medical attention, as a result of the Respiratory Tract Infection, after Visit 1
Time frame: Up to seven months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
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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.
John DeVincenzo, MD principal investigator
University of Tennessee
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections, run by Gilead Sciences at 15 sites in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms (time frame: Up to seven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2013.