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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00265187
Other study ID # 3350105
Secondary ID
Status Completed
Phase N/A
First received December 13, 2005
Last updated January 2, 2013
Start date December 2005
Est. completion date March 2006

Study information

Verified date August 2006
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

Sputum specimens will be obtained from children < 2 years of age and processed by different mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical and epidemiological data will also be obtained.


Description:

The purpose of the study is to asses the various pathogens of bronchiolitis in children and its' clinical manifestations. Prospective study in 3 Medical centers in Northern Israel. Included will be about 200 infants and children < 2 years hospitalized with bronchiolitis. From each child sputum specimen will be obtained and processed for HUMP - PCR, Pertussis - PCR, RSV - ELISA, DFA, PCR, Influenza A, B, Parainfluenza 1,2,3 - DFA, PCR, Adenovirus - DFA. Epidemiological data will be obtained for every child by structured questioner. Clinical data will be daily obtained by scoring system.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 2 Years
Eligibility Inclusion Criteria:Age 0-24 months, hospitalized children, -

Exclusion Criteria:Previous hospitalization, previous RSV immunization, immunocompromised patient, previous inclusion in this study, inclusion in another study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Israel Pediatric department A, HaEmek Medical Center Afula
Israel Maier Hospital Haifa
Israel Pediatric Depart ment , Bnai Zion Hospital Haifa

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

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