Pneumococcal InfectionIPD in saudiNCT00844467
A Retrospective Epidemiological Study on Pneumococcal Infection in Children in Ministry of Health Hospital at EHSA Region in the Eastern Province
An observational study of Pneumococcal Infection, run by King Saud University.
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. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- serotypes and resistance
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: children under 5 years with invasive pneumococccal dis.
Who may be able to join
- Invasive pneumococcal disease
- Children under 5 years
- Children lived in Elhasa region
Who cannot join
- Children above 5 years
- No invasive pneumococcal disease
About this study
Official title: Serotyping of Pneumococci
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).
Read the 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.
- Conditions
- Pneumococcal Infection
- Being tested
- serotypes and resistance
- Keywords
- Risk factors, Case fatality, disease burden, Resistance, Benefits of pneumococcal vaccination
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serotypes and resistanceBiological
screening patients with invasive pneumococci
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844467
- Sponsor's protocol ID
- king Saud university
- Acronym
- IPD in saudi
- Status last verified
- Feb 2009
- First submitted
- 10 Feb 2009
- Last updated
- 16 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotyping of Pneumococci
- ClinicalTrials.gov ID
- NCT00844467
- Acronym / sponsor ID
- IPD in saudi / king Saud university
- Conditions
- Pneumococcal Infection
- Keywords
- Risk factors, Case fatality, disease burden, Resistance, Benefits of pneumococcal vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children under 5 years with invasive pneumococccal dis.
Key inclusion criteria (3 listed)
- Invasive pneumococcal disease
- Children under 5 years
- Children lived in Elhasa region
Key exclusion criteria (2 listed)
- Children above 5 years
- No invasive pneumococcal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serotypes and resistancescreening patients with invasive pneumococci | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infection, run by King Saud University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2009.