Expired Study
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Buffalo, New York 14222


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).


Study summary:

- 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.


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.


Study is Available At:


Original ID:

MI-CP096


NCT ID:

NCT00192439


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

24 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

MedImmune LLC


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Defined Population, Observat


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

1500


Enrollment Type:

Actual


Overall Contact Information

Official Name:Margarita Gomez, M.D.
Study Director
MedImmune LLC

Study Dates

Start Date:December 2003
Completion Date:December 2006
Completion Type:Actual
Verification Date:May 2007
Last Changed Date:May 4, 2007
First Received Date:September 12, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Behavioral
Name:High Risk Respiratory Disease

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:MedImmune LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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