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

Completed

• Conditions: Severe Respiratory Disease

• Registration Number: NCT00192439
• Lead Sponsor: MedImmune LLC

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Study Completion: 2006-12
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-04
• Last Update Posted: 2007-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (23)

Miller Children's Hospital; 🇺🇸 Long Beach, California, United States

The Children's Hospital; 🇺🇸 Buffalo, New York, United States

Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

New England Medical Center; 🇺🇸 Boston, Massachusetts, 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

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