Nasopharyngeal Streptococcus Pneumoniae Carriage

Streptococcus Pneumoniae Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471822
• Other study ID #: 0887X-101849
• Secondary ID: B1841034
• Status: Completed
• Phase: N/A
• First received: May 8, 2007
• Last updated: September 18, 2013
• Start date: July 2005
• Est. completion date: December 2010

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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 aureus strain

• The influence of risk factors in the Streptococcus pneumoniae carriage rate in children

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9707
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 5 Years

Eligibility

Inclusion Criteria:

1. Children aged between 2 months and 5 years attending pediatric clinics in hospitals, day care centers or kindergartens.

2. Informed consent obtained from parents or legal guardian.

Exclusion Criteria:

1. Children younger than 2 months of age.

2. Children with following serious diseases: immunological disease, neoplastic disease, renal, cardiac or hematological disease, bronchodysplasia, Down's syndrome.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumococcal Infections
• Pneumonia
• Streptococcus Pneumoniae Infections

Locations

Country	Name	City	State
Taiwan	Pfizer Investigational Site	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1	No
Secondary	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.	Day 1	No
Secondary	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.	Day 1	No
Secondary	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.	Day 1	No
Secondary	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.	Day 1	No

External Links

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