Nasopharyngeal Streptococcus Pneumoniae Carriage

Completed

• Conditions: Streptococcus Pneumoniae Infections

• Registration Number: NCT00471822
• Lead Sponsor: Pfizer

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2007-05-08
• Study First Submitted QC: 2007-05-09
• Study First Posted: 2007-05-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-10-03
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-18
• Last Update Submitted: 2013-09-18
• Results First Posted: 2013-11-20
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9707

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx	Day 1	Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.

Secondary Outcome Measures

Name	Time	Method
Antibiotic-Resistant Streptococcus Pneumoniae Strains	Day 1	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.
Serotype Distribution of Streptococcus Pneumoniae Isolates	Day 1	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.
Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril	Day 1	Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains.
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors	Day 1	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Taoyuan, Taiwan