Streptococcus Pneumoniae InfectionsNCT00471822
Nasopharyngeal Streptococcus Pneumoniae Carriage
An observational study of Streptococcus Pneumoniae Infections, run by Pfizer at 1 site in Taiwan.
Trial summary
Primary Objective: Evaluation of the Carriage rate of Streptococcus pneumoniae in the nasopharynx of children Secondary Objective: Carriage rate and distribution of Streptococcus pneumoniae serotypes Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains Distribution of Staphylococcus… Read more about this study
- Who is it for?
- Ages 2 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae Infections
- How many people
- 9,707 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2005to Dec 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Subjects aged between 2 months and 5 years attending pediatric clinics in hospitals, daycare centers, and kindergartens
Who may be able to join
- Children aged between 2 months and 5 years attending pediatric clinics in hospitals, day care centers or kindergartens.
- Informed consent obtained from parents or legal guardian.
Who cannot join
- Children younger than 2 months of age.
- Children with following serious diseases: immunological disease, neoplastic disease, renal, cardiac or hematological disease, bronchodysplasia, Down's syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Taiwanese Children Attending Pediatric Clinics in Hospitals, Day Care Centers, or Kindergartens
Primary Objective: Evaluation of the
- Carriage rate of Streptococcus pneumoniae in the nasopharynx of children
Secondary Objective:
- Carriage rate and distribution of Streptococcus pneumoniae serotypes
- Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains
- Distribution of Staphylococcus aureus strain
- The influence of risk factors in the Streptococcus pneumoniae carriage rate in children
- Conditions
- Streptococcus Pneumoniae Infections
- Keywords
- Streptococcus pneumoniae nasopharyngeal carriage
- Medical subject headings
- Pneumococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx
Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.
Measured: Day 1
Secondary outcomes (4)
Serotype Distribution of Streptococcus Pneumoniae Isolates
Streptococcus pneumoniae in swab culture of nasopharynx were serotyped. The assessment included 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F, non-vaccine, non-typable and missing serotypes. Percentage of participants under different vaccine serotypes in identified isolates of streptococcus pneumonia are reported.
Measured: Day 1
Antibiotic-Resistant Streptococcus Pneumoniae Strains
Antibiotic resistance is defined as in vitro inhibition of a particular bacterial strain by a concentration of the drug associated with high likelihood of therapeutic failure. Antibiotic resistance for streptococcus pneumoniae was assessed against Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole. The standard breakpoint value (microbial growth inhibition zone) for Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole was not more than 8, 4, 13, 15 and 15 millimeter (mm) respectively. Percentage of participants with antibiotic-resistant streptococcus pneumoniae strains are reported. The same participant may have streptococcus pneumoniae strains which is resistance to more than one antibiotic.
Measured: Day 1
Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril
Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains.
Measured: Day 1
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Participants for carriage of streptococcus pneumoniae were analyzed with respect to various risk factors which included number of bathrooms, number of siblings in the family (multiple siblings), size of the house in meter square (house area), frequency of hand wash in a day, bed sharing, smoking by family member, child breast feeding (breast milk practice), daycare attendance, vaccination for flu and pneumococcus, history of otitis media and upper respiratory infection (URI), antibiotic use and influenza virus infection.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startJul 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Streptococcus Pneumoniae InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 9,707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471822
- Sponsor's protocol ID
- 0887X-101849
- Other IDs
- B1841034
- Status last verified
- Sep 2013
- First submitted
- 8 May 2007
- Last updated
- 20 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. 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 Taiwanese Children Attending Pediatric Clinics in Hospitals, Day Care Centers, or Kindergartens
- ClinicalTrials.gov ID
- NCT00471822
- Acronym / sponsor ID
- 0887X-101849
- Conditions
- Streptococcus Pneumoniae Infections
- Keywords
- Streptococcus pneumoniae nasopharyngeal carriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,707 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 May 2007 (estimated)
- Results
- Posted 20 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective: Evaluation of the
- Carriage rate of Streptococcus pneumoniae in the nasopharynx of children
Secondary Objective:
- Carriage rate and distribution of Streptococcus pneumoniae serotypes
- Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains
- Distribution of Staphylococcus aureus strain
- The influence of risk factors in the Streptococcus pneumoniae carriage rate in children
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects aged between 2 months and 5 years attending pediatric clinics in hospitals, daycare centers, and kindergartens
Key inclusion criteria (2 listed)
- Children aged between 2 months and 5 years attending pediatric clinics in hospitals, day care centers or kindergartens.
- Informed consent obtained from parents or legal guardian.
Key exclusion criteria (2 listed)
- Children younger than 2 months of age.
- Children with following serious diseases: immunological disease, neoplastic disease, renal, cardiac or hematological disease, bronchodysplasia, Down's syndrome.
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
Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx
Time frame: Day 1
Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.
4 secondary outcomes
Serotype Distribution of Streptococcus Pneumoniae Isolates
Time frame: Day 1
Antibiotic-Resistant Streptococcus Pneumoniae Strains
Time frame: Day 1
Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril
Time frame: Day 1
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae Infections, run by Pfizer at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 20 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx (time frame: Day 1). 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 20 Nov 2013; AzTrials last refreshed its copy on 4 Nov 2026.