N/A
N=9,707
Nasopharyngeal Streptococcus Pneumoniae Carriage
Streptococcus Pneumoniae Infections
Bottom Line
View on ClinicalTrials.gov: NCT00471822 ↗Enrolled (actual)
9,707
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx — 12.6 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx |
12.6 | — |
| SECONDARY Serotype Distribution of Streptococcus Pneumoniae Isolates |
0.00; 0.08; 0.98; 0.00; 0.00; 18.04 | — |
| SECONDARY Antibiotic-Resistant Streptococcus Pneumoniae Strains |
0.65; 3.51; 1.47; 95.43; 76.00 | — |
| SECONDARY Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril |
25.9 | — |
| SECONDARY Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors |
12.6; 12.7; 12.5; 12.9; 14.9; 8.3 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00471822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.