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OpenTrials
Completed

NCT Number: NCT00471822

Nasopharyngeal Streptococcus Pneumoniae Carriage

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

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Key information

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

Taoyuan, 333, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx

    Time frame: Day 1

    Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.

Secondary outcomes

  1. Serotype Distribution of Streptococcus Pneumoniae Isolates

    Time frame: 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.

  2. Antibiotic-Resistant Streptococcus Pneumoniae Strains

    Time frame: 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.

  3. Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril

    Time frame: Day 1

    Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
May 10, 2007
Registry last updated
Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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