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

MedImmune

Status: Completed

Conditions: Bronchiolitis; Respiratory Infections; Apnea; Pneumonia

Treatments: Other: Emergency Dept. Subjects with LRI or Apnea

Study type: Observational

Funder types: Industry

Identifiers

NCT00369759

MI-MA133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,048 patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

2,048 participants in 3 patient groups

1

Description:

Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)

Treatment:

Other: Emergency Dept. Subjects with LRI or Apnea

2

Description:

Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)

Treatment:

Other: Emergency Dept. Subjects with LRI or Apnea

3

Description:

Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)

Treatment:

Other: Emergency Dept. Subjects with LRI or Apnea