Nasopharyngeal Streptococcus Pneumoniae Carriage

Pfizer9,707 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

9,707

Conditions

Streptococcus Pneumoniae Infections

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Taoyuan District, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: Day 1

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Day 1

Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors

Data from ClinicalTrials.gov

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