An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00369759
First received: August 24, 2006
Last updated: March 16, 2009
Last verified: March 2009

August 24, 2006
March 16, 2009
September 2006
July 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00369759 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods. [ Time Frame: July 2008 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
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.

  • 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Nasal wash specimen (RSV)

Non-Probability Sample

Eligible subjects with RSV results.

  • Respiratory Infections
  • Bronchiolitis
  • Pneumonia
  • Apnea
Other: Emergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study
  • 1
    Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
    Intervention: 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)
    Intervention: 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)
    Intervention: Other: Emergency Dept. Subjects with LRI or Apnea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2048
September 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

A) Acute LRI, defined as:

  1. Medical diagnosis of bronchiolitis or pneumonia, or
  2. 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:

    • 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

B) Apnea, defined as either:

  1. Cessation of breathing for >20 seconds by history or observation, or
  2. Cessation of breathing for any length of time if accompanied by cyanosis or pallor, bradycardia as detected by a monitor, or
  3. ED primary diagnosis of apnea

    • Parent/guardian has the ability and willingness to be available for a follow-up interview by telephone

Exclusion Criteria:

  • Use of palivizumab or RSV-IGIV at any time prior to enrollment
  • Participation in trials of investigational RSV prophylaxis or therapeutic agents
Both
up to 12 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00369759
MI-MA133
No
Jessie Groothuis, MD, MedImmune Inc.
MedImmune LLC
Not Provided
Study Director: Jessie R. Groothuis, M.D. MedImmune LLC
MedImmune LLC
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP