Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk

A Study to Describe the Incidence Rate and Clinical Features of Human Meta Pneumovirus (hMPV) Infection of the Lower Respiratory Tract in Hospitalized Children at High Risk for Severe Disease

- Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at <2 years of age).

Study Overview

• Status: Completed
• Conditions: Severe Respiratory Disease
• Intervention / Treatment: Behavioral: High Risk Respiratory Disease

Detailed Description

• A prospective, epdemiological study to estimate the incidence rate of hMPV infection as determined by RT-PCR from frozen nasal wash aspirates taken from children hospitalized with LRI who are at high risk for severe disease.
• No study drug will be administered for this study.

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • University Dept. of Paediatrics, Women's and Children's Hospital
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Royal Children's Hospital, Murdoch Children's Research Institute
  • Western Australia
    • Perth, Western Australia, Australia, 6014
      • University of Western Australia
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2J3
      • University of Alberta
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Univ. of Mannitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • IWK Health Centre
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
• Italy
  • Milan, Italy, 20122
    • Institute of Pediatrics, University of Milan
• United States
  • California
    • Long Beach, California, United States, 90806
      • Miller Children's Hospital
  • Colorado
    • Denver, Colorado, United States, 80218
      • The Children's Hospital
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Children's Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • New England Medical Center
  • New York
    • Buffalo, New York, United States, 14222
      • The Children's Hospital
    • New Hyde Park, New York, United States, 11040
      • Schneider Children's Hospital, Long Island Jewish Medical Center
    • Rochester, New York, United States, 14642
      • Univ. Of Rochester Medical Center
    • Syracuse, New York, United States, 13210
      • Suny Upstate Medical Univ.
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Univ. School of Medicine
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 80218
      • Children's Hospital of Pittsburgh
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital, Dept. of Pediatrics
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • LeBonheur Children's Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • Univ. Of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Washington
    • Seattle, Washington, United States, 98105
      • Children's Hospital and Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be premature (less than 36 weeks gestation) and less than or equal to 12 months of age, and/or
• Be less than or equal to 24 months of age with CHD (other than uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus) that is judged to be hemodynamically significant, and/or
• Be less than or equal to 24 months of age with CLD of prematurity (BPD) requiring medical intervention/management (i.e., supplemental oxygen, steroids, bronchodilators, or diuretics within the previous 6 months).
• Hospital admission diagnosis referable to an acute lower respiratory tract infection or cardio/respiratory illness with a presumed respiratory infection (e.g., bronchiolitis, bronchitis, or pneumonia or cardiac decompensation associated with respiratory infection); admission must occur between October 1 and June 30 for northern hemisphere sites, and between March 1 and November 30 for southern hemisphere sites.
• Study enrollment within 2 days after hospitalization.
• Admission from the community to the Pediatric ward, Neonatal Intensive Care Unit, or the Intensive Care Unit.
• Have written informed consent obtained from the parent or legal guardian prior to study entry.

Exclusion Criteria:

• Known HIV infection or a mother with known HIV infection.

Study Plan

How is the study designed?

Design Details

• Observational Models: Defined Population
• Time Perspectives: Other

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Study Director: Margarita Gomez, M.D., MedImmune LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion: December 7, 2022
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): May 7, 2007
• Last Update Submitted That Met QC Criteria: May 4, 2007
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: MI-CP096

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No