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

Completed

Conditions studied: Severe Respiratory Disease

In brief

\- 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).

Key facts

Study ID

NCT00192439

Run by

MedImmune LLC

People needed

1500

Starts

2003-12-01

Expected to finish

2006-12-01

Last updated by the study team

2007-05-07

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.