Respiratory InfectionsNCT00369759
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
An observational study of Respiratory Infections and Bronchiolitis, run by MedImmune LLC at 38 sites in United States.
Trial summary
The primary objective of this study is to describe the incidence of RSV-associated LRI among infants <1 year of age presenting to the ED during selected shoulder months. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Respiratory Infections, Bronchiolitis, Pneumonia
- What is being tested?
- Emergency Dept. Subjects with LRI or Apnea
- How many people
- 2,048 participants
- Where
- 38 sitesUnited States
- Study dates
- Sep 2006to Sep 2008
- 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Eligible subjects with RSV results.
Who may be able to join
- Written informed consent from parent/guardian to participate in this study
- Male and female infants <1 year of age (child must be entered before his/her 1st birthday)
- Physician diagnosis of either a) acute LRI or b) apnea below:
- Acute LRI, defined as:
- Medical diagnosis of bronchiolitis or pneumonia, or
- In the absence of either of these diagnoses, LRI will be determined by the investigator after review of the medical record and must include at least one of the following:
Show all 15Show fewer
- Retractions
- Wheezing
- Rales or crackles
- The presence of a new infiltrate, if a chest X-ray is available, which must be diagnosed by the ED physician or radiologist
- Apnea, defined as either:
- Cessation of breathing for >20 seconds by history or observation, or
- Cessation of breathing for any length of time if accompanied by cyanosis or pallor, bradycardia as detected by a monitor, or
- ED primary diagnosis of apnea
- Parent/guardian has the ability and willingness to be available for a follow-up interview by telephone
Who cannot join
- Use of palivizumab or RSV-IGIV at any time prior to enrollment
- Participation in trials of investigational RSV prophylaxis or therapeutic agents
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Emory University
Atlanta, Georgia, 30329
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Children's National Medical Center
Baltimore, Maryland, 21201
University of Maryland
Baltimore, Maryland, 21201
Children's Hospital of Buffalo
Buffalo, New York, 14222
Medical University of SC
Charleston, South Carolina, 29425
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Case Western Reserve University
Cleveland, Ohio, 44106
Columbus Children's Hospital - Nationwide Children's of Colombus
Columbus, Ohio, 43205
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9063
University of Texas, Southwestern Medical Center
Dallas, Texas, 75390
The Children's Medical Center of Dayton
Dayton, Ohio, 45404
The Children's Hospital
Denver, Colorado, 80218
Children's Hospital of Michigan
Detroit, Michigan, 48201
Hurley Medical Center
Flint, Michigan, 48503
University of Mississippi
Jackson, Mississippi, 39216
University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research
Lexington, Kentucky, 40536-0298
University of Tennesee, LeBonheur Children's Med. Center
Memphis, Tennessee, 38103
Batchelor Children's Institute
Miami, Florida, 33136
Miami Children's Hospital Research Institute
Miami, Florida, 33155
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Medical College of Wisconsin
Milwaukee, Wisconsin, 53326
University of Nebraska Medical Center combined Divistion of Pediatric Infectious Disease
Omaha, Nebraska, 68178
Temple University Children's Medical Center
Philadelphia, Pennsylvania, 19140
Maricopa Medical Center
Phoenix, Arizona, 85008
Doernbecher Children's Hospital Oregon Health Sciences University Hospital
Portland, Oregon, 97239
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, 98105-0371
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130
St. Louis Children's Hospital (Washington University)
St Louis, Missouri, 63110
Olive View- UCLA Medical Center
Sylmar, California, 91342
Upstate Medical University
Syracuse, New York, 13202
Austin Children's Hospital
Temple, Texas, 76502
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803-3607
Alfred J. Dupont Hospital for Children
Wilmington, Delaware, 19803-3607
Wake Forest University Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: An Epidemiological Study to Evaluate the Seasonality of Respiratory Syncytial Virus-Associated-Lower Respiratory Tract Infections (LRI) or Apnea in Infants in the Emergency Department
The primary objective of this study is to describe the incidence of RSV-associated LRI among infants <1 year of age presenting to the ED during selected shoulder months.
Read the detailed description
- The primary objective of this study is to describe the incidence of RSV-associated LRI or apnea (% RSV positive) among infants <1 year of age presenting to the ED during selected shoulder months. The total number of events will also be described.
- To characterize the clinical outcomes and demographic data of infants presenting to the ED with RSV-associated LRI or apnea
- To characterize the social burden (in the form of number of days lost from work by parent/ guardian) for these infants through 14 days after the index ED visit and through hospital discharge will also be described.
- Based on a sample of cases collected in a cohort of patients enrolled at or near the peak of RSV disease during the traditional season, a comparison of the rate of RSV between shoulder and peak periods will be described.
- To describe the overall rates of RSV-associated LRI or apnea based on the general ED statistics collected during the entire study period.
- Conditions
- Respiratory Infections, Bronchiolitis, Pneumonia, Apnea
- Being tested
- Emergency Dept. Subjects with LRI or Apnea
- Keywords
- Acute Lower Respiratory Infection, Retractions, Bronchiolitis or pneumonia, Wheezing, Rales, Crackles
- Medical subject headings
- Respiratory Tract Infections, Bronchiolitis, Pneumonia, Apnea, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Dept. Subjects with LRI or ApneaOther
No intervention; Epidemiological Study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08) Receives: Other: Emergency Dept. Subjects with LRI or Apnea | |
| 2 | Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08) Receives: Other: Emergency Dept. Subjects with LRI or Apnea | |
| 3 | Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08) Receives: Other: Emergency Dept. Subjects with LRI or Apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.
Measured: July 2008
Secondary outcomes (4)
Clinical outcome of infants at Emergency Dept. with RSV-associated LRI or apnea.(hospital admission, 23 hr.-observations,no. of outpatient and/or urgent care visits,ICU,mechanical ventilation,supplemental oxygen use, meds,admission rate)
Measured: July 2008
Societal burden(no. of days lost from work by parent/guardian) for infants through 14 days after index ED visit and through hospital discharge.
Measured: July 2008
Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods.
Measured: July 2008
Overall rates of RSV-associated LRI or apnea based on general ED statistics collected during the entire study period, including outside recruitment periods.
Measured: July 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jessie R. Groothuis, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369759
- Sponsor's protocol ID
- MI-MA133
- Status last verified
- Mar 2009
- First submitted
- 24 Aug 2006
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Study to Evaluate the Seasonality of Respiratory Syncytial Virus-Associated-Lower Respiratory Tract Infections (LRI) or Apnea in Infants in the Emergency Department
- ClinicalTrials.gov ID
- NCT00369759
- Acronym / sponsor ID
- MI-MA133
- Conditions
- Respiratory Infections, Bronchiolitis, Pneumonia, Apnea
- Keywords
- Acute Lower Respiratory Infection, Retractions, Bronchiolitis or pneumonia, Wheezing, Rales, Crackles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,048 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 Aug 2006 (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 primary objective of this study is to describe the incidence of RSV-associated LRI among infants <1 year of age presenting to the ED during selected shoulder months.
Detailed description
- The primary objective of this study is to describe the incidence of RSV-associated LRI or apnea (% RSV positive) among infants <1 year of age presenting to the ED during selected shoulder months. The total number of events will also be described.
- To characterize the clinical outcomes and demographic data of infants presenting to the ED with RSV-associated LRI or apnea
- To characterize the social burden (in the form of number of days lost from work by parent/ guardian) for these infants through 14 days after the index ED visit and through hospital discharge will also be described.
- Based on a sample of cases collected in a cohort of patients enrolled at or near the peak of RSV disease during the traditional season, a comparison of the rate of RSV between shoulder and peak periods will be described.
- To describe the overall rates of RSV-associated LRI or apnea based on the general ED statistics collected during the entire study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Emergency Dept. Subjects with LRI or ApneaBronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08) |
| 2 | – | Other: Emergency Dept. Subjects with LRI or ApneaBronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08) |
| 3 | – | Other: Emergency Dept. Subjects with LRI or ApneaBronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08) |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Eligible subjects with RSV results.
Key inclusion criteria (15 listed)
- Written informed consent from parent/guardian to participate in this study
- Male and female infants <1 year of age (child must be entered before his/her 1st birthday)
- Physician diagnosis of either a) acute LRI or b) apnea below:
- Acute LRI, defined as:
- Medical diagnosis of bronchiolitis or pneumonia, or
Key exclusion criteria (2 listed)
- Use of palivizumab or RSV-IGIV at any time prior to enrollment
- Participation in trials of investigational RSV prophylaxis or therapeutic agents
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 |
|---|---|---|
| Emergency Dept. Subjects with LRI or ApneaNo intervention; Epidemiological Study | Other | 1, 2, 3 |
Primary outcome
Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.
Time frame: July 2008
4 secondary outcomes
Clinical outcome of infants at Emergency Dept. with RSV-associated LRI or apnea.(hospital admission, 23 hr.-observations,no. of outpatient and/or urgent care visits,ICU,mechanical ventilation,supplemental oxygen use, meds,admission rate)
Time frame: July 2008
Societal burden(no. of days lost from work by parent/guardian) for infants through 14 days after index ED visit and through hospital discharge.
Time frame: July 2008
Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods.
Time frame: July 2008
Overall rates of RSV-associated LRI or apnea based on general ED statistics collected during the entire study period, including outside recruitment periods.
Time frame: July 2008
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 17 Mar 2009.
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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.
Jessie R. Groothuis, M.D. study director
MedImmune LLC
38 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 Infections and Bronchiolitis, run by MedImmune LLC at 38 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 15 inclusion and 2 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 17 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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?
Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months. (time frame: July 2008). 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 17 Mar 2009.