Nasopharyngeal Streptococcus Pneumoniae Carriage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00471822
First received: May 8, 2007
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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

Condition
Streptococcus Pneumoniae Infections

Study Type: Observational
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.


Enrollment: 9707
Study Start Date: July 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471822

Locations
Taiwan
Pfizer Investigational Site
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00471822     History of Changes
Other Study ID Numbers: 0887X-101849, B1841034
Study First Received: May 8, 2007
Results First Received: October 3, 2012
Last Updated: September 18, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Pfizer:
Streptococcus pneumoniae nasopharyngeal carriage

Additional relevant MeSH terms:
Pneumococcal Infections
Pneumonia
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 26, 2014