CMV Infection in Adolescent Males
Seroprevalence and Prospective Risk Factor Analysis of Cytomegalovirus (CMV) Infection in Adolescent Males
1 other identifier
observational
411
1 country
3
Brief Summary
The purpose of this study is to find out more about cytomegalovirus (CMV) and how it is spread between people. One thousand adolescent males ages 12-17 years will participate in this study. Participants will be given a questionnaire about risk factors for CMV. A small blood sample (2-3 teaspoons) will be taken to test for CMV infection. Subjects that are CMV seronegative may participate in the second part of this study, which will involve returning to the clinic at regularly scheduled visit times to provide blood, urine, and saliva (spit) samples. This part of the study will take at least 24 months to complete. Subjects that test positive for CMV during the 2nd portion of the study will be invited to participate in the 3rd part of the study. This part of the study will require 8 regularly scheduled visits to provide blood, urine and saliva samples, over a 12-month period. The maximum amount of time a subject will participate in the study is 36 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2006
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2006
CompletedFirst Posted
Study publicly available on registry
March 13, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedNovember 11, 2011
November 1, 2009
2.5 years
March 9, 2006
November 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Seroprevalence of CMV infection in adolescent boys
Obtained every month for 4 months and then every 2 months for 8 months.
Prospectively determine the incidence of CMV infection.
Day 0 and every 3 months for 24 months.
Determine the duration and magnitude of CMV replication in the blood, urine, and saliva by specimens.
Obtained every month for 4 months and then every 2 months for 8 months.
Secondary Outcomes (2)
Prospectively identify risk factors for infection.
Day 0 and every 3 months for 24 months.
Identify risk factors for CMV infection by comparing those subjects who are CMV seropositive with those subjects who are CMV seronegative.
Screening
Study Arms (2)
CMV positive
CMV +, N=500/167
CMV negative
CMV -, N=500/167
Eligibility Criteria
1000 males aged 12 - 17 years will be recruited from participating adolescent clinics at Cincinnati Children's Hospital Medical Center (CCHMC), Vanderbilt University Medical Center, and the University of Texas Medical Branch Galveston.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Vanderbilt University
Nashville, Tennessee, 37232-9900, United States
The University of Texas Medical Branch
Galveston, Texas, 77555, United States
Biospecimen
Blood, urine and salvia samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 9, 2006
First Posted
March 13, 2006
Study Start
June 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
November 11, 2011
Record last verified: 2009-11