NCT00844467

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Shorter than P25 for all trials

Status
unknown

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

Study Start

First participant enrolled

February 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

Enrollment Period

8 months

First QC Date

February 10, 2009

Last Update Submit

February 13, 2009

Conditions

Pneumococcal Infection

Keywords

Risk factorsCase fatalitydisease burdenResistanceBenefits of pneumococcal vaccination

Interventions

serotypes and resistanceBIOLOGICAL

screening patients with invasive pneumococci

Eligibility Criteria

Age3 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children under 5 years with invasive pneumococccal dis.

You may qualify if:

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

You may not qualify if:

  • Children above 5 years
  • No invasive pneumococcal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Serogroup

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

PhenotypeGenetic Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 16, 2009

Study Start

February 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

February 16, 2009

Record last verified: 2009-02