Streptococcus Pneumoniae Infections
Conditions
Keywords
Streptococcus pneumoniae nasopharyngeal carriage
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
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 5 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx | Day 1 | Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype Distribution of Streptococcus Pneumoniae Isolates | 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. |
| Antibiotic-Resistant Streptococcus Pneumoniae Strains | 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. |
| Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril | Day 1 | 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 | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Potential Carriers Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains. | 9,705 |
| Total | 9,705 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | All Potential Carriers |
|---|---|
| Age Continuous | 2.05 Years STANDARD_DEVIATION 1.41 |
| Sex: Female, Male Female | 4429 Participants |
| Sex: Female, Male Male | 5276 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 359 / 9,705 |
| serious Total, serious adverse events | 1 / 9,705 |
Outcome results
Primary
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.
Time frame: Day 1
Population: Evaluable population included all the participants who met inclusion and exclusion criteria for the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx | 12.6 Percentage of Participants |
Secondary
Antibiotic-Resistant Streptococcus Pneumoniae Strains
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.
Time frame: Day 1
Population: Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, 'N' (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Potential Carriers | Antibiotic-Resistant Streptococcus Pneumoniae Strains | Cefotaxime | 3.51 Percentage of Carrier Participants |
| All Potential Carriers | Antibiotic-Resistant Streptococcus Pneumoniae Strains | Levofloxacin | 1.47 Percentage of Carrier Participants |
| All Potential Carriers | Antibiotic-Resistant Streptococcus Pneumoniae Strains | Erythromycin | 95.43 Percentage of Carrier Participants |
| All Potential Carriers | Antibiotic-Resistant Streptococcus Pneumoniae Strains | Penicillin | 0.65 Percentage of Carrier Participants |
| All Potential Carriers | Antibiotic-Resistant Streptococcus Pneumoniae Strains | Trimethoprim-sulfamethoxazole | 76.00 Percentage of Carrier Participants |
Secondary
Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril
Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains.
Time frame: Day 1
Population: Evaluable population included all participants who met inclusion and exclusion criteria for the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Potential Carriers | Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril | 25.9 Percentage of Participants |
Secondary
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
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.
Time frame: Day 1
Population: Evaluable population included all the participants who met inclusion and exclusion criteria for the study. 'n' signifies those participants who were evaluated for the respective risk factor.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | URI in last 2 weeks : Yes (n=2940) | 19.5 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Antibiotic use : Yes (n=574) | 22.1 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Frequency of hand wash : >8 (n=1783) | 13.1 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Bed sharing : Yes (n=8689) | 12.9 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Bed sharing : No (n=1016) | 10.1 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Family member smoking : Yes (n=4546) | 13.8 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Family member smoking : No (n=5159) | 11.6 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Breast milk practice : Yes (n=7000) | 12.2 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Breast milk practice : No (n=2705) | 13.6 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Daycare attendance : Yes (n=1783) | 25.4 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Daycare attendance : No (n=7922) | 9.8 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Flu vaccine : Yes (n=3993) | 13.7 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Flu vaccine : No (n=5712) | 11.9 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Pneumoccal vaccine : Yes (n=2225) | 9.8 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Pneumoccal vaccine : No (n=7480) | 13.4 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Otitis media : Yes (n=894) | 21.6 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Otitis media : No (n=8811) | 11.7 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | URI in last 2 weeks : No (n=6765) | 9.6 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Antibiotic use : No (n=9131) | 12.0 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Influenza virus infection : Yes (n=21) | 28.6 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Influenza virus infection : No (n=9684) | 12.6 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Bathroom : Less than or equal to (<=) 2 (n=6061) | 12.6 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Bathroom : Greater than (>) 2 (n=3644) | 12.7 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | House area : <=50 (n=5698) | 12.5 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | House area : >50 (n=4007) | 12.9 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Multiple siblings : >1 (n=6383) | 14.9 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Multiple siblings : Only 1 (n=3320) | 8.3 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Frequency of hand wash : Less than (<) 4 (n=2646) | 9.1 Percentage of Participants |
| All Potential Carriers | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Frequency of hand wash : 4 to 8 (n=5276) | 14.2 Percentage of Participants |
Secondary
Serotype Distribution of Streptococcus Pneumoniae Isolates
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.
Time frame: Day 1
Population: Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, 'N' (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 4 | 0.00 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 5 | 0.00 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 6B | 18.04 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 1 | 0.00 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 2 | 0.08 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 3 | 0.98 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 7F | 0.00 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 8 | 0.41 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 9N | 0.08 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 9V | 0.41 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 10A | 0.16 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 11A | 0.24 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 12F | 0.00 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 14 | 6.37 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 15B | 5.63 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 17F | 0.00 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 18C | 0.16 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 19A | 1.88 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 19F | 17.47 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 20 | 0.00 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 22F | 0.16 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 23F | 11.59 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | 33F | 0.00 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | Non-vaccine serotype | 21.80 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | Non-typable | 12.33 Percentage of Carrier Participants |
| All Potential Carriers | Serotype Distribution of Streptococcus Pneumoniae Isolates | Missing | 2.20 Percentage of Carrier Participants |