Pneumonia, BacterialNCT00724828
Study Evaluating Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Filipino Children
An observational study of Pneumonia, Bacterial, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes Read more about this study
- Who is it for?
- Ages 2 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Bacterial
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Nov 2005
- 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 2 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary care clinic
Who may be able to join
- Healthy children aged between 2 months and 5 years attending the well baby clinic in hospital.
- Informed consent obtained from parents or legal guardian.
Who cannot join
None listed.
About this study
Official title: An Evaluation of Streptococcus Pneumoniae Serotype Carriage Rate For Nasopharyngeal Carriage in Filipino Children Attending Well Baby Clinic in Hospitals and Primary Care Centers
Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes
- Conditions
- Pneumonia, Bacterial
- Keywords
- Bacterial otitis media, pneumoniae, sepsis, bacteremia, meningitis, Streptococcus pneumoniae carriage rate
- Medical subject headings
- Pneumonia, Bacterial, Sepsis, Bacteremia, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Streptococcus pneumoniae serotype carriage rate based on a nasopharyngeal swab.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startMay 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, BacterialStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724828
- Sponsor's protocol ID
- 0887X-101959
- Status last verified
- Jul 2008
- First submitted
- 25 Jul 2008
- Last updated
- 30 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Streptococcus Pneumoniae Serotype Carriage Rate For Nasopharyngeal Carriage in Filipino Children Attending Well Baby Clinic in Hospitals and Primary Care Centers
- ClinicalTrials.gov ID
- NCT00724828
- Acronym / sponsor ID
- 0887X-101959
- Conditions
- Pneumonia, Bacterial
- Keywords
- Bacterial otitis media, pneumoniae, sepsis, bacteremia, meningitis, Streptococcus pneumoniae carriage rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 30 Jul 2008 (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.
Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Healthy children aged between 2 months and 5 years attending the well baby clinic in hospital.
- Informed consent obtained from parents or legal guardian.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Streptococcus pneumoniae serotype carriage rate based on a nasopharyngeal swab.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Bacterial, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 30 Jul 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Streptococcus pneumoniae serotype carriage rate based on a nasopharyngeal swab. (time frame: 1 day). It is what the study was designed to measure, not a finding.
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 30 Jul 2008.