N/A
N=3,641
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
Streptococcus Pneumoniae Infections
Bottom Line
View on ClinicalTrials.gov: NCT00952367 ↗Enrolled (actual)
3,641
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae — 12.5; 7.2; 16.6; 9.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Nasopharyngeal swab (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae |
12.5; 7.2; 16.6; 9.3; 10.5; 18.9 | — |
| PRIMARY Percentage of Participants With Serotypes of Streptococcus Pneumoniae |
28.4; 7.5; 6.7; 6.7; 6.4; 3.5 | — |
| SECONDARY Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B |
4.3; 8.0; 5.7; 2.3; 3.4; 4.2 | — |
| SECONDARY Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis |
11.7; 11.1; 9.8; 7.9; 8.2; 17.4 | — |
| SECONDARY Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics |
18.6; 1.1; 1.1; 23.5; 4.0; 83.6 | — |
| SECONDARY Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics |
0.0; 0.0; 1.2; 0.0; 2.4; 19.6 | — |
| SECONDARY Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics |
0.0; 0.0; 21.0; 0.0; 22.7 | — |
| SECONDARY Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae |
0.248; -0.116; 1.087; 0.326; 0.209; -0.068 | <0.001 sig |
| SECONDARY Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B |
-0.683; -0.204; 0.227; -0.287; 2.857; -0.126 | 0.057 |
| SECONDARY Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis |
-0.412; -0.303; 0.280; 0.104; 0.199; 0.166 | 0.019 sig |
Summary
This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged 12-18 months in order to estimate the prevalence of pathogens that commonly cause infection in Chinese young children. The antibiotic resistance of all isolates and the serotypes distribution of S.p. isolates will also be tested. Potential risk factors for nasopharyngeal carriage will be collected.
Eligibility Criteria
Inclusion Criteria
- Healthy children aged 12-18 months
Exclusion Criteria
- Use of antibiotics up to 15 days prior to study inclusion
- Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible
- Children with chronic infectious (chronic otitis media or chronic sinusitis prior to study inclusion.
- Received any pneumococcal vaccine in the past.
- Children who have already provided a NP sample in the same study period.
- Any relevant hemorrhagic disorder.
- Any febrile process (fever ≥ 38°C) at time of screening.
Data sourced from ClinicalTrials.gov (NCT00952367). 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.