Trial Outcomes & Findings for Nasopharyngeal Streptococcus Pneumoniae Carriage (NCT NCT00471822)
NCT ID: NCT00471822
Last Updated: 2013-11-20
Results Overview
Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.
Recruitment status
COMPLETED
Target enrollment
9707 participants
Primary outcome timeframe
Day 1
Results posted on
2013-11-20
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
9707
|
|
Overall Study
Treated
|
9705
|
|
Overall Study
COMPLETED
|
9705
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Nasopharyngeal Streptococcus Pneumoniae Carriage
Baseline characteristics by cohort
| Measure |
All Potential Carriers
n=9705 Participants
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.
|
|---|---|
|
Age Continuous
|
2.05 Years
STANDARD_DEVIATION 1.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4429 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5276 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Evaluable population included all the participants who met inclusion and exclusion criteria for the study.
Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.
Outcome measures
| Measure |
All Potential Carriers
n=9705 Participants
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.
|
|---|---|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx
|
12.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
All Potential Carriers
n=1225 Participants
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.
|
|---|---|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
1
|
0.00 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
2
|
0.08 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
3
|
0.98 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
4
|
0.00 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
5
|
0.00 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
6B
|
18.04 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
7F
|
0.00 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
8
|
0.41 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
9N
|
0.08 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
9V
|
0.41 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
10A
|
0.16 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
11A
|
0.24 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
12F
|
0.00 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
14
|
6.37 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
15B
|
5.63 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
17F
|
0.00 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
18C
|
0.16 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
19A
|
1.88 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
19F
|
17.47 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
20
|
0.00 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
22F
|
0.16 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
23F
|
11.59 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
33F
|
0.00 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
Non-vaccine serotype
|
21.80 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
Non-typable
|
12.33 Percentage of Carrier Participants
|
|
Serotype Distribution of Streptococcus Pneumoniae Isolates
Missing
|
2.20 Percentage of Carrier Participants
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
All Potential Carriers
n=1225 Participants
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.
|
|---|---|
|
Antibiotic-Resistant Streptococcus Pneumoniae Strains
Penicillin
|
0.65 Percentage of Carrier Participants
|
|
Antibiotic-Resistant Streptococcus Pneumoniae Strains
Cefotaxime
|
3.51 Percentage of Carrier Participants
|
|
Antibiotic-Resistant Streptococcus Pneumoniae Strains
Levofloxacin
|
1.47 Percentage of Carrier Participants
|
|
Antibiotic-Resistant Streptococcus Pneumoniae Strains
Erythromycin
|
95.43 Percentage of Carrier Participants
|
|
Antibiotic-Resistant Streptococcus Pneumoniae Strains
Trimethoprim-sulfamethoxazole
|
76.00 Percentage of Carrier Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Evaluable population included all participants who met inclusion and exclusion criteria for the study.
Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains.
Outcome measures
| Measure |
All Potential Carriers
n=9705 Participants
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.
|
|---|---|
|
Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril
|
25.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
All Potential Carriers
n=9705 Participants
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.
|
|---|---|
|
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
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Bathroom : Greater than (>) 2 (n=3644)
|
12.7 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
House area : <=50 (n=5698)
|
12.5 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
House area : >50 (n=4007)
|
12.9 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Multiple siblings : >1 (n=6383)
|
14.9 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Multiple siblings : Only 1 (n=3320)
|
8.3 Percentage of Participants
|
|
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
|
|
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
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Frequency of hand wash : >8 (n=1783)
|
13.1 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Bed sharing : Yes (n=8689)
|
12.9 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Bed sharing : No (n=1016)
|
10.1 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Family member smoking : Yes (n=4546)
|
13.8 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Family member smoking : No (n=5159)
|
11.6 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Breast milk practice : Yes (n=7000)
|
12.2 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Breast milk practice : No (n=2705)
|
13.6 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Daycare attendance : Yes (n=1783)
|
25.4 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Daycare attendance : No (n=7922)
|
9.8 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Flu vaccine : Yes (n=3993)
|
13.7 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Flu vaccine : No (n=5712)
|
11.9 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Pneumoccal vaccine : Yes (n=2225)
|
9.8 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Pneumoccal vaccine : No (n=7480)
|
13.4 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Otitis media : Yes (n=894)
|
21.6 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Otitis media : No (n=8811)
|
11.7 Percentage of Participants
|
|
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
|
|
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
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Antibiotic use : Yes (n=574)
|
22.1 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Antibiotic use : No (n=9131)
|
12.0 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Influenza virus infection : Yes (n=21)
|
28.6 Percentage of Participants
|
|
Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
Influenza virus infection : No (n=9684)
|
12.6 Percentage of Participants
|
Adverse Events
All Potential Carriers
Serious events: 1 serious events
Other events: 359 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Potential Carriers
n=9705 participants at risk
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.
|
|---|---|
|
Infections and infestations
Bronchiolitis
|
0.01%
1/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
All Potential Carriers
n=9705 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.08%
8/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.02%
2/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
1.2%
117/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchiolitis
|
0.01%
1/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.01%
1/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpangina
|
0.01%
1/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.47%
46/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis media acute
|
0.01%
1/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.01%
1/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.04%
4/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Injury
|
0.02%
2/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.62%
60/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.09%
9/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.08%
8/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.2%
115/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.26%
25/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.07%
7/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.01%
1/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.01%
1/9705
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER