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

Severe Respiratory Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192439
• Other study ID #: MI-CP096
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 4, 2007
• Start date: December 2003
• Est. completion date: December 2006

Study information

• Verified date: May 2007
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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 Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Tract Diseases
• Severe Respiratory Disease

Intervention

Behavioral:
• High Risk Respiratory Disease

Locations

Country	Name	City	State
Australia	University Dept. of Paediatrics, Women's and Children's Hospital	North Adelaide	South Australia
Australia	Royal Children's Hospital, Murdoch Children's Research Institute	Parkville	Victoria
Australia	University of Western Australia	Perth	Western Australia
Canada	University of Alberta	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	Univ. of Mannitoba	Winnipeg	Manitoba
Italy	Institute of Pediatrics, University of Milan	Milan
United States	New England Medical Center	Boston	Massachusetts
United States	The Children's Hospital	Buffalo	New York
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Univ. of Texas Southwestern Medical Center	Dallas	Texas
United States	The Children's Hospital	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Miller Children's Hospital	Long Beach	California
United States	Lebonheur Children's Medical Center	Memphis	Tennessee
United States	Schneider Children's Hospital, Long Island Jewish Medical Center	New Hyde Park	New York
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital, Dept. of Pediatrics	Providence	Rhode Island
United States	Univ. of Rochester Medical Center	Rochester	New York
United States	Children's Hospital and Regional Medical Center	Seattle	Washington
United States	Suny Upstate Medical Univ.	Syracuse	New York
United States	Wake Forest Univ. School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Italy,