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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
  Purpose

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.


Condition Intervention
Respiratory Infections
Bronchiolitis
Pneumonia
Apnea
Other: Emergency Dept. Subjects with LRI or Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Nasal wash specimen (RSV)


Enrollment: 2048
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
Other: Emergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study
2
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
Other: Emergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study
3
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
Other: Emergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study

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.
  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligible subjects with RSV results.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369759

  Show 38 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Jessie R. Groothuis, M.D. MedImmune LLC
  More Information

No publications provided

Responsible Party: Jessie Groothuis, MD, MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00369759     History of Changes
Other Study ID Numbers: MI-MA133
Study First Received: August 24, 2006
Last Updated: March 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by MedImmune LLC:
Acute Lower Respiratory Infection
Retractions
Bronchiolitis or pneumonia
Wheezing
Rales
Crackles

Additional relevant MeSH terms:
Bronchiolitis
Communicable Diseases
Infection
Pneumonia
Respiratory Tract Infections
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014