Nasopharyngeal Streptococcus Pneumoniae Carriage

NCT00471822 | Completed Results

• 2 other identifiers: 0887X-101849B1841034
• Study Type: observational
• Target: 9,707
• Locations: 1 country
• Sites: 1

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

Conditions

Streptococcus Pneumoniae Infections

Keywords

Streptococcus pneumoniae nasopharyngeal carriage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Serotype Distribution of Streptococcus Pneumoniae Isolates

  Day 1

• Antibiotic-Resistant Streptococcus Pneumoniae Strains

  Day 1

• Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril

  Day 1

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

  Day 1

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Children aged between 2 months and 5 years attending pediatric clinics in hospitals, day care centers or kindergartens.
• Informed consent obtained from parents or legal guardian.

You may not qualify if:

• Children younger than 2 months of age.
• Children with following serious diseases: immunological disease, neoplastic disease, renal, cardiac or hematological disease, bronchodysplasia, Down's syndrome.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Taoyuan District, 333, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: July 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 20, 2013
• Results First Posted: November 20, 2013

Record last verified: 2013-09

Locations

TW (1)