A Retrospective Epidemiological Study on Pneumococcal Infection in Children in Ministry of Health Hospital at EHSA Region in the Eastern Province (IPD in saudi)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00844467
Recruitment Status : Unknown
Verified February 2009 by King Saud University.
Recruitment status was:  Active, not recruiting
First Posted : February 16, 2009
Last Update Posted : February 16, 2009
Information provided by:
King Saud University

Brief 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).

Condition or disease Intervention/treatment
Pneumococcal Infection Biological: serotypes and resistance

Detailed 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.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Serotyping of Pneumococci
Study Start Date : February 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Biological: serotypes and resistance
    screening patients with invasive pneumococci

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children under 5 years with invasive pneumococccal dis.

Inclusion Criteria:

  • Invasive pneumococcal disease
  • Children under 5 years
  • Children lived in Elhasa region

Exclusion Criteria:

  • Children above 5 years
  • No invasive pneumococcal disease

Responsible Party: King saud university, King saud univ Identifier: NCT00844467     History of Changes
Other Study ID Numbers: king Saud university
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

Keywords provided by King Saud University:
Risk factors
Case fatality
disease burden
Benefits of pneumococcal vaccination

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections