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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00192439




Registration number
NCT00192439
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
7/05/2007

Titles & IDs
Public title
Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk
Scientific 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
Secondary ID [1] 0 0
MI-CP096
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Respiratory Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Behaviour - High Risk Respiratory Disease

Behaviour: High Risk Respiratory Disease
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
1 Day
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known HIV infection or a mother with known HIV infection.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
1500
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
University Dept. of Paediatrics, Women's and Children's Hospital - North Adelaide
Recruitment hospital [2] 0 0
Royal Children's Hospital, Murdoch Children's Research Institute - Parkville
Recruitment hospital [3] 0 0
University of Western Australia - Perth
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6014 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Rhode Island
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Manitoba
Country [14] 0 0
Canada
State/province [14] 0 0
Nova Scotia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Italy
State/province [16] 0 0
Milan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00192439
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Margarita Gomez, M.D.
Address 0 0
MedImmune LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00192439