Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192439
First received: September 12, 2005
Last updated: May 4, 2007
Last verified: May 2007
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | May 4, 2007 | ||||
| Start Date ICMJE | December 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00192439 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk | ||||
| Official Title ICMJE | 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 | ||||
| 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). |
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| Detailed Description |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Severe Respiratory Disease | ||||
| Intervention ICMJE | Behavioral: High Risk Respiratory Disease | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1500 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 24 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Canada, Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00192439 | ||||
| Other Study ID Numbers ICMJE | MI-CP096 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | MedImmune LLC | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | MedImmune LLC | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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