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
  Purpose

- 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).


Condition Intervention
Severe Respiratory Disease
Behavioral: High Risk Respiratory Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
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

Further study details as provided by MedImmune LLC:

Enrollment: 1500
Study Start Date: December 2003
Study Completion Date: December 2006
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

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192439

  Show 24 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Margarita Gomez, M.D. MedImmune LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192439     History of Changes
Other Study ID Numbers: MI-CP096
Study First Received: September 12, 2005
Last Updated: May 4, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014