Nasopharyngeal Streptococcus Pneumoniae Carriage
This study has been completed.
Information provided by (Responsible Party):
First received: May 8, 2007
Last updated: September 18, 2013
Last verified: September 2013
Primary Objective: Evaluation of the
- Carriage rate of Streptococcus pneumoniae in the nasopharynx of children
- 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
Streptococcus Pneumoniae Infections
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.
Secondary Outcome Measures:
- Serotype Distribution of Streptococcus Pneumoniae Isolates [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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.
- Antibiotic-Resistant Streptococcus Pneumoniae Strains [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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.
- Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2005|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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