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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192439
First received: September 12, 2005
Last updated: May 4, 2007
Last verified: May 2007

September 12, 2005
May 4, 2007
December 2003
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Complete list of historical versions of study NCT00192439 on ClinicalTrials.gov Archive Site
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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).

  • 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.
Observational
Observational Model: Defined Population
Time Perspective: Cross-Sectional
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Severe Respiratory Disease
Behavioral: High Risk Respiratory Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
December 2006
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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.
Both
up to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Italy
 
NCT00192439
MI-CP096
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MedImmune LLC
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Study Director: Margarita Gomez, M.D. MedImmune LLC
MedImmune LLC
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP