Clinical trial NCT00192439: Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Respiratory Disease
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: - 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).

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Miller Children's Hospital
state: California
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Buffalo
country: United States
facility: The Children's Hospital
state: New York
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital, Long Island Jewish Medical Center
state: New York
city: Rochester
country: United States
facility: Univ. of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: Suny Upstate Medical Univ.
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Univ. School of Medicine
state: North Carolina
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital, Dept. of Pediatrics
state: Rhode Island
city: Memphis
country: United States
facility: Lebonheur Children's Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Univ. of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
city: North Adelaide
country: Australia
facility: University Dept. of Paediatrics, Women's and Children's Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Children's Hospital, Murdoch Children's Research Institute
state: Victoria
city: Perth
country: Australia
facility: University of Western Australia
state: Western Australia
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Winnipeg
country: Canada
facility: Univ. of Mannitoba
state: Manitoba
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Milan
country: Italy
facility: Institute of Pediatrics, University of Milan
Study officials:
affiliation: MedImmune LLC
name: Margarita Gomez, M.D.
role: STUDY_DIRECTOR
References: