Nasopharyngeal Streptococcus Pneumoniae Carriage

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

Study Overview

• Status: Completed
• Conditions: Streptococcus Pneumoniae Infections

• Study Type: Observational
• Enrollment (Actual): 9707

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects aged between 2 months and 5 years attending pediatric clinics in hospitals, daycare centers, and kindergartens

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 8, 2007
• First Submitted That Met QC Criteria: May 9, 2007
• First Posted (Estimate): May 10, 2007

Study Record Updates

• Last Update Posted (Estimate): November 20, 2013
• Last Update Submitted That Met QC Criteria: September 18, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Streptococcus pneumoniae nasopharyngeal carriage
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal
• Other Study ID Numbers: 0887X-101849; B1841034