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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00844467
Other study ID # king Saud university
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 10, 2009
Last updated February 13, 2009
Start date February 2009
Est. completion date December 2009

Study information

Verified date February 2009
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: Research Advisory Council
Study type Observational

Clinical Trial Summary

The purpose of this study is to establish retrospectively the incidence rates of invasive pneumococcal disease in children aged less than 5 years. The investigators allocate the El Hasa region for the study because it has higher incidence of sickle cell anemia. The study will include data from 2003 to 2007(before introduction of the vaccine) and then for 2008 and 2009 (after introduction of the vaccine).


Description:

Data will be collected from patents files or records for 5 years before the introduction of the vaccine and for 2 years after the introduction of the vaccine. We assigned 4 doctors in each hospital to carry and supervise the work.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date December 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 5 Years
Eligibility Inclusion Criteria:

- Invasive pneumococcal disease

- Children under 5 years

- Children lived in Elhasa region

Exclusion Criteria:

- Children above 5 years

- No invasive pneumococcal disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
serotypes and resistance
screening patients with invasive pneumococci

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
King Saud University
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