Trial Outcomes & Findings for Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain. (NCT NCT02838407)
NCT ID: NCT02838407
Last Updated: 2019-10-04
Results Overview
Bacterial aetiology was assessed by culture growth from BAL fluid sample for Steptococcus pneumoniae (S.p.), Haemophilus influenzae (H.i.) and Moraxella catarrhalis (M.c.) , through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.), negative (Neg.) and Missing (Mis.). For quantitative bacterial identification, S.p., H.i. and M.c. were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or \>10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
COMPLETED
NA
197 participants
From Day 0 up to Year 2
2019-10-04
Participant Flow
Participant milestones
| Measure |
Total Group
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Overall Study
STARTED
|
197
|
|
Overall Study
COMPLETED
|
197
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain.
Baseline characteristics by cohort
| Measure |
Total Group
n=197 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Age, Continuous
|
40.7 Months
STANDARD_DEVIATION 18.2 • n=93 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available.
Bacterial aetiology was assessed by culture growth from BAL fluid sample for Steptococcus pneumoniae (S.p.), Haemophilus influenzae (H.i.) and Moraxella catarrhalis (M.c.) , through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.), negative (Neg.) and Missing (Mis.). For quantitative bacterial identification, S.p., H.i. and M.c. were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or \>10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Pos. qualitative B.I. for any of the 3 bacteria
|
141 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Neg. qualitative B.I. for any of the 3 bacteria
|
49 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Mis. qualitative B.I. for any of the 3 bacteria
|
1 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Pos. qualitative B.I. for S. pneumoniae
|
58 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Neg. qualitative B.I. for S. pneumoniae
|
132 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Mis. qualitative B.I. for S. pneumoniae
|
1 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Pos. qualitative B.I. for H. influenzae
|
97 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Neg. qualitative B.I. for H. influenzae
|
93 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Mis. qualitative B.I. for H. influenzae
|
1 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Pos. qualitative B.I. for M. catarrhalis
|
94 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Neg. qualitative B.I. for M. catarrhalis
|
96 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Mis. qualitative B.I. for M. catarrhalis
|
1 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Pos. qualitative B.I. for other bacteria
|
12 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Neg. qualitative B.I. for other bacteria
|
0 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Mis. qualitative B.I. for other bacteria
|
179 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Pos. quantitative B.I. for any of the 3 bacteria
|
42 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Neg. quantitative B.I. for any of the 3 bacteria
|
148 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Mis. quantitative B.I. for any of the 3 bacteria
|
1 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Pos. quantitative B.I. for S. pneumoniae
|
20 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Neg. quantitative B.I. for S. pneumoniae
|
170 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Mis. quantitative B.I. for S. pneumoniae
|
1 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Pos. quantitative B.I. for H. influenzae
|
17 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Neg. quantitative B.I. for H. influenzae
|
173 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Mis. quantitative B.I. for H. influenzae
|
1 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Pos. quantitative B.I. for M. catarrhalis
|
12 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Neg. quantitative B.I. for M. catarrhalis
|
178 Participants
|
|
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Mis. quantitative B.I. for M. catarrhalis
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available.
S. pneumoniae (S.p.), H. influenzae (H.i.) and M. catarrhalis (M.c.) were confirmed by bacterial identification (B.I.) load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or \>10\^5 cfu/mL if presented as co-infection. Analysis was also performed for other bacterial pathogens alone or as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
S.p. alone (B.I. >10^4 cfu/mL)
|
15 Participants
|
|
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
H.i. alone (B.I. >10^4 cfu/mL)
|
14 Participants
|
|
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
M.c. alone (B.I. >10^4 cfu/mL)
|
6 Participants
|
|
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
Other bacterial pathogens - Any load
|
12 Participants
|
|
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
Other bacterial pathogens alone - Any load
|
10 Participants
|
|
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
S.p. and H.i. (B.I. >10^5 cfu/mL)
|
1 Participants
|
|
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
S.p. and M.c. (B.I. >10^5 cfu/mL)
|
4 Participants
|
|
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
H.i. and M.c. (B.I. >10^5 cfu/mL)
|
2 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with negative M.catarrhalis BAL Fluid samples results available.
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone. Bacterial load referred to Negative M. catarrhalis - Negative S. pneumoniae - Negative H. influenzae (N.M.c.-N.S.p.-N.H.i.), Negative M. catarrhalis - Negative S. pneumoniae - Positive H. influenzae (N.M.c.-N.S.p.-P.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (N.M.c.-P.S.p.-N.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (N.M.c.-P.S.p.-P..H.i.). Notes: bacterial identification for the N.M.c.-P.S.p.-P.H.i. category was confirmed as a co-infection with a bacterial load \>10\^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=178 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Negative M. Catarrhalis" BAL Fluid Samples Results Category)
N.M.c.-N.S.p.-N.H.i.
|
148 Participants
|
|
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Negative M. Catarrhalis" BAL Fluid Samples Results Category)
N.M.c.-N.S.p.-P.H.i.
|
14 Participants
|
|
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Negative M. Catarrhalis" BAL Fluid Samples Results Category)
N.M.c.-P.S.p.-N.H.i.
|
15 Participants
|
|
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Negative M. Catarrhalis" BAL Fluid Samples Results Category)
N.M.c.-P.S.p.-P.H.i.
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with positive M.catarrhalis BAL Fluid samples results available.
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone and by bacterial load \>10\^5 cfu/mL if presented as co-infection. Categories referred to Positive M. catarrhalis -Negative S. pneumoniae - Negative H. influenzae (P.M.c.-N.S.p.-N.H.i.), Positive M. catarrhalis -Negative S. pneumoniae - Positive H. influenzae (P.M.c.-N.S.p.-P.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (P.M.c.-P.S.p.-N.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (P.M.c.-P.S.p.-P.H.i.). Notes: bacterial identification for the P.M.c.-N.S.p.-P.H.i., P.M.c.-P.S.p.-N.H.i. and P.M.c.-P.S.p.-P.H.i. categories was confirmed by a bacterial identification \>10\^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Outcome measures
| Measure |
Total Group
n=12 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Positive M. Catarrhalis" BAL Fluid Samples Results Category)
P.M.c.-N.S.p.-N.H.i.
|
6 Participants
|
|
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Positive M. Catarrhalis" BAL Fluid Samples Results Category)
P.M.c.-N.S.p.-P.H.i.
|
2 Participants
|
|
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Positive M. Catarrhalis" BAL Fluid Samples Results Category)
P.M.c.-P.S.p.-N.H.i.
|
4 Participants
|
|
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Positive M. Catarrhalis" BAL Fluid Samples Results Category)
P.M.c.-P.S.p.-P.H.i.
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with nasopharyngeal swab sampling results available.
Bacterial colonization was assessed by culture growth from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis, through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.) and negative (Neg.).
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Pos. qualitative B.I. for any of the 3 bacteria
|
154 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Neg. qualitative B.I. for any of the 3 bacteria
|
37 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Pos. qualitative B.I. for S. pneumoniae
|
99 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Neg. qualitative B.I. for S. pneumoniae
|
92 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Pos. qualitative B.I. for H. influenzae
|
89 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Neg. qualitative B.I. for H. influenzae
|
102 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Pos. qualitative B.I. for M. catarrhalis
|
107 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Neg. qualitative B.I. for M. catarrhalis
|
84 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Pos. quantitative B.I. for any of the 3 bacteria
|
37 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Neg. quantitative B.I. for any of the 3 bacteria
|
154 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Pos. quantitative B.I. for S. pneumoniae
|
24 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Neg. quantitative B.I. for S. pneumoniae
|
167 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Pos. quantitative B.I. for H. influenzae
|
7 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Neg. quantitative B.I. for H. influenzae
|
184 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Pos. quantitative B.I. for M. catarrhalis
|
10 Participants
|
|
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Neg. quantitative B.I. for M. catarrhalis
|
181 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available for the outcome measure.
Bacterial load was detected by quantitative culture growth from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=97 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples
S. pneumoniae Bacterial load
|
4.28 cfu/mL
Standard Deviation 1.04
|
|
Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples
H. influenzae Bacterial load
|
3.81 cfu/mL
Standard Deviation 1.11
|
|
Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples
M. catarrhalis Bacterial load
|
3.54 cfu/mL
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: From Day 0 up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available for the outcome measure.
Bacterial load was detected by quantitative molecular techniques (PCR) from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=138 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples
S. pneumoniae Bacterial load
|
4.06 cfu/mL
Standard Deviation 1.27
|
|
Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples
H. influenzae Bacterial load
|
4.31 cfu/mL
Standard Deviation 1.32
|
|
Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples
M. catarrhalis Bacterial load
|
3.92 cfu/mL
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: From Day 0 up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available.
Bacterial pathogens were detected by qualitative culture from BAL fluid samples and included: Staphylococcus aureus, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Pseudomonas putida. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
Staphylococcus aureus (Growth)
|
1 Participants
|
|
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
Pseudomonas aeruginosa (Growth)
|
5 Participants
|
|
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
Stenotrophomonas maltophilia (Growth)
|
4 Participants
|
|
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
Pseudomonas putida (Growth)
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with nasopharyngeal swab sampling results available for the outcome measure.
Bacterial load was detected by quantitative culture from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection.
Outcome measures
| Measure |
Total Group
n=107 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples
H. influenzae Bacterial load
|
3.61 cfu/mL
Standard Deviation 0.88
|
|
Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples
S. pneumoniae Bacterial load
|
3.99 cfu/mL
Standard Deviation 1.15
|
|
Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples
M. catarrhalis Bacterial load
|
3.36 cfu/mL
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: From Day 0 and up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with nasopharyngeal swab sampling results available for the outcome measure.
Bacterial load was detected by quantitative molecular techniques from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection.
Outcome measures
| Measure |
Total Group
n=133 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples
S. pneumoniae Bacterial load
|
4.39 cfu/mL
Standard Deviation 1.13
|
|
Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples
H. influenzae Bacterial load
|
4.16 cfu/mL
Standard Deviation 1.17
|
|
Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples
M. catarrhalis Bacterial load
|
4.05 cfu/mL
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: From Day 0 and up to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with nasopharyngeal swab sampling results available.
Bacterial pathogens were detected by qualitative culture from nasopharyngeal swab samples and included: Staphylococcus aureus and Stenotrophomonas maltophilia
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples
Stenotrophomonas maltophilia (Growth)
|
1 Participants
|
|
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples
Staphylococcus aureus (Growth)
|
6 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable unique isolates of subjects for S. pneumoniae, who complied with the protocol and with BAL fluid sampling results available.
Two isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. S.p. serogoups and serotypes isolates included: 3, 6B, 7C, 10A, 11A, 11D, 12F, 14, 15B, 16F, 18C, 18F, 19A, 19F, 21, 22F, 23A, 23B, 31, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Outcome measures
| Measure |
Total Group
n=65 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
3
|
2 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
6B
|
4 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
7C
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
10A
|
3 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
11A
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
11D
|
4 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
12F
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
14
|
3 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
15B
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
16F
|
2 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
18C
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
18F
|
10 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
19A
|
3 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
19F
|
4 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
21
|
4 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
22F
|
2 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
23A
|
4 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
23B
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
31
|
4 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
35F
|
3 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
42
|
2 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
48
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
NT
|
4 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
Synflorix serotypes
|
15 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
PCV13 serotypes
|
17 unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable unique isolates of subjects for H. influenzae, who complied with the protocol and with BAL fluid sampling results available.
The H. influenzae typing results included "f" and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Outcome measures
| Measure |
Total Group
n=98 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples
f
|
3 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples
NT
|
95 unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable unique isolates of subjects for S. pneumoniae, who complied with the protocol and with nasopharyngeal swab sampling results available.
S. pneumoniae serogoups and serotypes included: 3, 6A, 6B, 7C, 9N, 10A, 11A, 11D, 12B, 12F, 14, 16F, 18C, 18F, 19A, 19C, 19F, 21, 23A, 23B, 31, 35A, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Outcome measures
| Measure |
Total Group
n=105 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
3
|
2 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
6A
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
6B
|
6 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
7C
|
2 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
9N
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
10A
|
5 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
11A
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
11D
|
5 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
12B
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
12F
|
3 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
14
|
2 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
16F
|
3 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
18C
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
18F
|
14 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
19A
|
6 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
19C
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
19F
|
9 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
21
|
7 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
23A
|
5 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
23B
|
2 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
31
|
3 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
35A
|
1 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
35F
|
3 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
42
|
6 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
48
|
4 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
NT
|
11 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
Synflorix serotypes
|
24 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
PCV13 serotypes
|
27 unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable unique isolates of subjects for H. influenzae, who complied with the protocol and with nasopharyngeal swab sampling results available.
The H. influenzae typing results include "f " and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Outcome measures
| Measure |
Total Group
n=92 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples
NT
|
88 unique isolates of subjects
|
|
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples
f
|
4 unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the S. pneumoniae unique isolates from qualitative positive subjects who were included in the ATP cohort.
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=105 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Penicilin (NPS)
|
55 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Azithromycin (BALF)
|
41 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Erythromycin (BALF)
|
21 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Penicilin (BALF)
|
36 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Penicilin (BALF)
|
13 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Penicilin (BALF)
|
16 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Penicilin (NPS)
|
27 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Penicilin (NPS)
|
23 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Amoxicillin/ Clavulanate (BALF)
|
50 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Amoxicillin/ Clavulanate (BALF)
|
7 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Amoxicillin/ Clavulanate (BALF)
|
8 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Amoxicillin/ Clavulanate (NPS)
|
86 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Amoxicillin/ Clavulanate (NPS)
|
10 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Amoxicillin/ Clavulanate (NPS)
|
9 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Erythromycin (BALF)
|
43 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Erythromycin (BALF)
|
1 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Erythromycin (NPS)
|
55 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Erythromycin (NPS)
|
1 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Erythromycin (NPS)
|
49 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Azithromycin (BALF)
|
3 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Azithromycin (BALF)
|
21 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Azithromycin (NPS)
|
57 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Azithromycin (NPS)
|
4 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Azithromycin (NPS)
|
44 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Tetracycline (BALF)
|
51 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Tetracycline (BALF)
|
14 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Tetracycline (BALF)
|
0 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Tetracycline (NPS)
|
71 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Tetracycline (NPS)
|
3 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Tetracycline (NPS)
|
31 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Levofloxacin (BALF)
|
65 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Levofloxacin (BALF)
|
0 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Levofloxacin (BALF)
|
0 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Levofloxacin (NPS)
|
103 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Levofloxacin (NPS)
|
0 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Levofloxacin (NPS)
|
2 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (BALF)
|
24 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (BALF)
|
13 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (BALF)
|
28 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (NPS)
|
52 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (NPS)
|
13 unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (NPS)
|
40 unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the H. influenzae unique isolates from qualitative positive subjects who were included in the ATP cohort.
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcomes description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=98 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Tetracycline (NPS)
|
92 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Azithromycin (NPS)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Azithromycin (NPS)
|
3 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Tetracycline (BALF)
|
98 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Tetracycline (BALF)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Tetracycline (BALF)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Tetracycline (NPS)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Tetracycline (NPS)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Levofloxacin (BALF)
|
98 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Levofloxacin (BALF)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Levofloxacin (BALF)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Levofloxacin (NPS)
|
92 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Levofloxacin (NPS)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (BALF)
|
51 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (BALF)
|
16 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (BALF)
|
31 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (NPS)
|
49 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (NPS)
|
18 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (NPS)
|
25 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Levofloxacin (NPS)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Amoxicillin/ Clavulanate (BALF)
|
91 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Amoxicillin/ Clavulanate (BALF)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Amoxicillin/ Clavulanate (BALF)
|
7 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Amoxicillin/ Clavulanate (NPS)
|
91 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Amoxicillin/ Clavulanate (NPS)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Amoxicillin/ Clavulanate (NPS)
|
1 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Azithromycin (BALF)
|
95 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Azithromycin (BALF)
|
0 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Azithromycin (BALF)
|
3 unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Azithromycin (NPS)
|
89 unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the H. influenzae unique isolates from qualitative positive subjects who were included in the ATP cohort.
Antibiotic response of H. influenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=98 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
Penicilin (BALF)
|
0.5 unique isolates of subjects
Interval 0.13 to 16.0
|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
Penicilin (NPS)
|
0.5 unique isolates of subjects
Interval 0.13 to 16.0
|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
Erythromycin (BALF)
|
4 unique isolates of subjects
Interval 1.0 to 16.0
|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
Erythromycin (NPS)
|
4.00 unique isolates of subjects
Interval 0.25 to 16.0
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the M. catarrhalis unique isolates from qualitative positive subjects who were included in the ATP cohort.
Antibiotic response of M. catarrhalis was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=110 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Amoxicillin/Clavulanate (BALF)
|
95 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Amoxicillin/Clavulanate (BALF)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Amoxicillin/Clavulanate (BALF)
|
3 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Amoxicillin/Clavulanate (NPS)
|
105 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Amoxicillin/Clavulanate (NPS)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Amoxicillin/Clavulanate (NPS)
|
5 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Erythromycin (BALF)
|
90 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Erythromycin (BALF)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Erythromycin (BALF)
|
8 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Erythromycin (NPS)
|
106 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Erythromycin (NPS)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Erythromycin (NPS)
|
4 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Azithromycin (BALF)
|
84 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Azithromycin (BALF)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Azithromycin (BALF)
|
14 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Azithromycin (NPS)
|
106 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Azithromycin (NPS)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Azithromycin (NPS)
|
4 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Tetracycline (BALF)
|
98 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Tetracycline (BALF)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Tetracycline (BALF)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Tetracycline (NPS)
|
110 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Tetracycline (NPS)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Tetracycline (NPS)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Levofloxacin (BALF)
|
98 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Levofloxacin (BALF)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Levofloxacin (BALF)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Levofloxacin (NPS)
|
110 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Levofloxacin (NPS)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Levofloxacin (NPS)
|
0 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (BALF)
|
56 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (BALF)
|
35 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (BALF)
|
7 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (NPS)
|
103 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (NPS)
|
7 unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole(NPS)
|
0 unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the M. catarrhalis unique isolates from qualitative positive subjects who were included in the ATP cohort.
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=110 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin
Penicilin (BALF)
|
8.00 unique isolates of subjects
Interval 0.02 to 16.0
|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin
Penicilin (NPS)
|
16.00 unique isolates of subjects
Interval 0.02 to 16.0
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the H. influenzae and M. catarrhalis unique isolates from qualitative positive subjects who were included in the ATP cohort.
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=110 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
H. influenzae (BALF)
|
7 unique isolates of subjects
|
|
Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
H. influenzae (NPS)
|
9 unique isolates of subjects
|
|
Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
M. catarrhalis (BALF)
|
93 unique isolates of subjects
|
|
Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
M. catarrhalis (NPS)
|
108 unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the S. pneumoniae unique isolates from quantitative positive subjects who were included in the ATP cohort.
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=26 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Penicilin (BALF)
|
4 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Penicilin (BALF)
|
15 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Penicilin (BALF)
|
2 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Penicilin (NPS)
|
11 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Penicilin (NPS)
|
10 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Penicilin (NPS)
|
5 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Amoxicillin/Clavulanate (BALF)
|
17 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Amoxicillin/Clavulanate (BALF)
|
3 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Amoxicillin/Clavulanate (BALF)
|
1 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Amoxicillin/Clavulanate (NPS)
|
22 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Amoxicillin/Clavulanate (NPS)
|
3 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Amoxicillin/Clavulanate (NPS)
|
1 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Erythromycin (BALF)
|
17 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Erythromycin (BALF)
|
0 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Erythromycin (BALF)
|
4 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Erythromycin (NPS)
|
11 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Erythromycin (NPS)
|
0 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Erythromycin (NPS)
|
15 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Azithromycin (BALF)
|
15 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Azithromycin (BALF)
|
2 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Azithromycin (BALF)
|
4 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Azithromycin (NPS)
|
11 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Azithromycin (NPS)
|
2 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Azithromycin (NPS)
|
13 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Tetracycline (BALF)
|
18 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Tetracycline (BALF)
|
0 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Tetracycline (BALF)
|
3 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Tetracycline (NPS)
|
16 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Tetracycline (NPS)
|
1 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Tetracycline (NPS)
|
9 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Levofloxacin (BALF)
|
21 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Levofloxacin (BALF)
|
0 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Levofloxacin (BALF)
|
0 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Levofloxacin (NPS)
|
25 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Levofloxacin (NPS)
|
0 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Levofloxacin (NPS)
|
1 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (BALF)
|
3 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (BALF)
|
5 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (BALF)
|
13 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (NPS)
|
12 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (NPS)
|
2 Unique isolates of subjects
|
|
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (NPS)
|
12 Unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the H. influenzae unique isolates from quantitative positive subjects who were included in the ATP cohort.
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\])towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcomes description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=18 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (NPS)
|
5 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (NPS)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Amoxicillin/Clavulanate (BALF)
|
15 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Amoxicillin/Clavulanate (BALF)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Amoxicillin/Clavulanate (BALF)
|
3 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Amoxicillin/Clavulanate (NPS)
|
8 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Amoxicillin/Clavulanate (NPS)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Amoxicillin/Clavulanate (NPS)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Azithromycin (BALF)
|
17 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Azithromycin (BALF)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Azithromycin (BALF)
|
1 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Azithromycin (NPS)
|
8 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Azithromycin (NPS)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Azithromycin (NPS)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Tetracycline (BALF)
|
18 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Tetracycline (BALF)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Tetracycline (BALF)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Tetracycline (NPS)
|
8 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Tetracycline (NPS)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Tetracycline (NPS)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Levofloxacin (BALF)
|
18 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Levofloxacin (BALF)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Levofloxacin (BALF)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Levofloxacin (NPS)
|
8 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Levofloxacin (NPS)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Levofloxacin (NPS)
|
0 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (BALF)
|
5 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (BALF)
|
7 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (BALF)
|
6 Unique isolates of subjects
|
|
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (NPS)
|
3 Unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the H. influenzae unique isolates from quantitative positive subjects who were included in the ATP cohort.
Antibiotic response of H.ifluenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=18 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
Penicilin (BALF)
|
0.50 Unique isolates of subjects
Interval 0.25 to 16.0
|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
Penicilin (NPS)
|
0.5 Unique isolates of subjects
Interval 0.13 to 16.0
|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
Erythromycin (BALF)
|
4.00 Unique isolates of subjects
Interval 2.0 to 16.0
|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
Erythromycin (NPS)
|
4.00 Unique isolates of subjects
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the M. catarrhalis unique isolates from quantitative positive subjects who were included in the ATP cohort.
Antibiotic response of M. catarrhalis was susceptible (Sus.), or intermediate (Int.), or resistant (Res.)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=13 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Amoxicillin/Clavulanate (BALF)
|
12 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Amoxicillin/Clavulanate (BALF)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Amoxicillin/Clavulanate (BALF)
|
1 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Amoxicillin/Clavulanate (NPS)
|
9 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Amoxicillin/Clavulanate (NPS)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Amoxicillin/Clavulanate (NPS)
|
1 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Erythromycin (BALF)
|
12 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Erythromycin (BALF)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Erythromycin (BALF)
|
1 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Erythromycin (NPS)
|
9 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Erythromycin (NPS)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Erythromycin (NPS)
|
1 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Azithromycin (BALF)
|
11 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Azithromycin (BALF)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Azithromycin (BALF)
|
2 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Azithromycin (NPS)
|
9 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Azithromycin (NPS)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Azithromycin (NPS)
|
1 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Tetracycline (BALF)
|
13 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Tetracycline (BALF)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Tetracycline (BALF)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Tetracycline (NPS)
|
10 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Tetracycline (NPS)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Tetracycline (NPS
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Levofloxacin (BALF)
|
13 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Levofloxacin (BALF)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Levofloxacin (BALF)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Levofloxacin (NPS)
|
10 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Levofloxacin (NPS)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Levofloxacin (NPS)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (BALF)
|
7 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (BALF)
|
5 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (BALF)
|
1 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Sus. Trimethoprim/Sulfamethoxazole (NPS)
|
10 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Int. Trimethoprim/Sulfamethoxazole (NPS)
|
0 Unique isolates of subjects
|
|
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Res. Trimethoprim/Sulfamethoxazole (NPS)
|
0 Unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the M. catarrhalis unique isolates from quantitative positive subjects who were included in the ATP cohort.
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=13 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin
Penicilin (BALF)
|
16.00 Unique isolates of subjects
Interval 0.5 to 16.0
|
|
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin
Penicilin (NPS)
|
16.00 Unique isolates of subjects
Interval 1.0 to 16.0
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the H. influenzae or M. catarrhalis unique isolates from quantitative positive subjects who were included in the ATP cohort.
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Outcome measures
| Measure |
Total Group
n=18 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
H. influenzae (BALF)
|
3 Unique isolates of subjects
|
|
Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
H. influenzae (NPS)
|
1 Unique isolates of subjects
|
|
Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
M. catarrhalis (BALF)
|
13 Unique isolates of subjects
|
|
Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
M. catarrhalis (NPS)
|
10 Unique isolates of subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Demographic characteristics included age, which was expressed in months.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Mean Age of Subjects
|
39.84 Months
Standard Deviation 17.76
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Demographic characteristics included gender: female and male.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Subject Gender
Gender (Female)
|
92 Participants
|
|
Subject Gender
Gender (Male)
|
99 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Demographic characteristics included weight which was expressed in kilograms (kg).
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Mean Weight of Subjects
|
14.67 Kilograms
Standard Deviation 3.83
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Demographic characteristics included height which was expressed in centimeters (cm).
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Mean Height of Subjects
|
96.04 Centimeters
Standard Deviation 13.10
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Demographic characteristics included body mass index (BMI) whose z-scores were measures of relative weight adjusted for child age and sex.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Body Mass Index (BMI) Characteristics
BMI - Marked thinness [< z-score (-3)]
|
5 Participants
|
|
Number of Subjects With Body Mass Index (BMI) Characteristics
BMI - Thinness [≥ z-score (-3) and < z-score (-2)]
|
9 Participants
|
|
Number of Subjects With Body Mass Index (BMI) Characteristics
BMI - Normal [≥ z-score (-2) and ≤ z-score (1)]
|
122 Participants
|
|
Number of Subjects With Body Mass Index (BMI) Characteristics
BMI - Overweight [> z-score (1) and ≤ z-score (2)]
|
26 Participants
|
|
Number of Subjects With Body Mass Index (BMI) Characteristics
BMI - Obesity [> z-score (2) and ≤ z-score (3)]
|
14 Participants
|
|
Number of Subjects With Body Mass Index (BMI) Characteristics
BMI - Extreme obesity [> z-score (3)]
|
4 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
General medical history characteristics included: any pre-existing conditions, congenital chromosomal abnormality, prematurity (less than 37 weeks) neonatal problems, chronic renal failure, immune system disorder (including auto-immune), atopic dermatitis, clinician-confirmed eczema, asthma and other.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects Presenting General Medical History Characteristics
Any other pre-existing conditions (Yes)
|
176 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Any other pre-existing conditions (No)
|
15 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Congenital chromosomal abnormality (Yes)
|
2 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Prematurity (<37 weeks) (Yes)
|
33 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Neonatal problems (Yes)
|
18 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Chronic renal failure (Yes)
|
1 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Immune system disorder (Yes)
|
1 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
History of inhaled steroids (Yes)
|
134 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Atopic dermatitis (Yes)
|
49 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Clinician-confirmed eczema (Yes)
|
4 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Asthma (Yes)
|
72 Participants
|
|
Number of Subjects Presenting General Medical History Characteristics
Other (Yes)
|
117 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
General medical history included mean gestational age.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Mean Gestational Age of Subjects
|
33.00 Weeks
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Pneumococcal vaccination history characteristics included vaccination, pneumococcal vaccines received (Prevnar only, Prevnar 13 only, Synflorix only, Mix of vaccines), Prevnar only doses (1-4), Prevnar 13 only doses (1-4), Synflorix only doses (4), medical history source validated or not.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Child has received any PCV (Yes)
|
168 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Child has received only Prevenar
|
15 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Child has received only Prevenar 13
|
123 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Child has received only Synflorix
|
1 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Child has received Mix of vaccines
|
29 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Doses of Prevenar (1)
|
2 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Doses of Prevenar (2)
|
4 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Doses of Prevenar (3)
|
3 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Doses of Prevenar (4)
|
6 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Doses of Prevenar 13 (1)
|
4 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Doses of Prevenar 13 (2)
|
12 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Doses of Prevenar 13 (3)
|
46 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Doses of Prevenar 13 (4)
|
61 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Doses of Synflorix (4)
|
1 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Validated source
|
165 Participants
|
|
Number of Subjects With Pneumococcal Vaccination History Characteristics
Not validated source
|
3 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Flu vaccination history included vaccination, Flu vaccine doses (1-5), medical history source validated or not.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Flu Vaccination History Characteristics
Child has ever received any flu vaccine (Yes)
|
58 Participants
|
|
Number of Subjects With Flu Vaccination History Characteristics
Number of doses of any flu vaccine (1)
|
18 Participants
|
|
Number of Subjects With Flu Vaccination History Characteristics
Number of doses of any flu vaccine (2)
|
26 Participants
|
|
Number of Subjects With Flu Vaccination History Characteristics
Number of doses of any flu vaccine (3)
|
6 Participants
|
|
Number of Subjects With Flu Vaccination History Characteristics
Number of doses of any flu vaccine (4)
|
5 Participants
|
|
Number of Subjects With Flu Vaccination History Characteristics
Number of doses of any flu vaccine (5)
|
3 Participants
|
|
Number of Subjects With Flu Vaccination History Characteristics
Validated source
|
52 Participants
|
|
Number of Subjects With Flu Vaccination History Characteristics
Not validated source
|
6 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Haemophilus influenzae type b vaccination history included vaccination, Haemophilus influenzae type b vaccine doses (1-4), medical history source validated or not.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Child has received H.I. type b vaccine (Yes)
|
188 Participants
|
|
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Number of doses of H.I. type b vaccine (1)
|
2 Participants
|
|
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Number of doses of H.I. type b vaccine (2)
|
4 Participants
|
|
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Number of doses of H.I. type b vaccine (3)
|
38 Participants
|
|
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Number of doses of H.I. type b vaccine (4)
|
144 Participants
|
|
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Validated source
|
184 Participants
|
|
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Not validated source
|
4 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Medication history referred to antibiotics administered in the past 6 months, drug names, antibiotic information source, other medications administered during the past 6 months, information source.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Antibiotics and Other Medications Administered
Antibiotic administered in the past 6 months (Yes)
|
153 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Penicillin
|
83 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Amoxicillin/ Clavulanate
|
76 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Cephalosporins
|
24 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Erythromycin
|
1 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Azithromycin
|
57 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Clarithromycin
|
8 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Ciprofloxacin
|
2 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Clindamycin
|
1 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Linezolid
|
1 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Meropenem
|
1 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Antibiotics source information. - parent recall
|
49 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Antibiotics source information. - medical file
|
120 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Other medications in the past 6 months (Yes)
|
177 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Source of information. - parent recall
|
49 Participants
|
|
Number of Subjects With Antibiotics and Other Medications Administered
Source of information. - medical file
|
149 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Clinical characteristics included affections/pre-conditions, affection episodes, number of children living in a household, children in day-care centres, exposure to cigarette smoke.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Clinical Characteristics
Shortness of breath secondary to cough (Yes)
|
33 Participants
|
|
Number of Subjects With Clinical Characteristics
Cough (Yes)
|
151 Participants
|
|
Number of Subjects With Clinical Characteristics
Wheezing (Yes)
|
86 Participants
|
|
Number of Subjects With Clinical Characteristics
Pathologic auscultation (Yes)
|
74 Participants
|
|
Number of Subjects With Clinical Characteristics
Infiltrates atelectasis diagnosed by X-ray (Yes)
|
131 Participants
|
|
Number of Subjects With Clinical Characteristics
Wet cough lasting 4 weeks without additional (Yes)
|
63 Participants
|
|
Number of Subjects With Clinical Characteristics
Persistent wheezing lasting 3 months (Yes)
|
8 Participants
|
|
Number of Subjects With Clinical Characteristics
Recurrent wheezing 3 or more episodes/year (Yes)
|
25 Participants
|
|
Number of Subjects With Clinical Characteristics
Persistent pathologic auscultation (Yes)
|
16 Participants
|
|
Number of Subjects With Clinical Characteristics
Persistent 1 month infiltrates atelectasis (Yes)
|
65 Participants
|
|
Number of Subjects With Clinical Characteristics
3 episodes/year infiltrates atelectasis (Yes)
|
14 Participants
|
|
Number of Subjects With Clinical Characteristics
Any respiratory/otitis media pre-conditions(Yes)
|
186 Participants
|
|
Number of Subjects With Clinical Characteristics
Any respiratory/otitis media pre- conditions (No)
|
5 Participants
|
|
Number of Subjects With Clinical Characteristics
Pneumonia (Yes)
|
114 Participants
|
|
Number of Subjects With Clinical Characteristics
Bronchiolitis (Yes)
|
85 Participants
|
|
Number of Subjects With Clinical Characteristics
Bronchioectasis (Yes)
|
15 Participants
|
|
Number of Subjects With Clinical Characteristics
Bronchitis (Yes)
|
143 Participants
|
|
Number of Subjects With Clinical Characteristics
Rhinitis (Yes)
|
15 Participants
|
|
Number of Subjects With Clinical Characteristics
Acute otitis media (Yes)
|
53 Participants
|
|
Number of Subjects With Clinical Characteristics
Otitis media with effusion or glue ear (Yes)
|
6 Participants
|
|
Number of Subjects With Clinical Characteristics
Otitis media with perforation and discharge (Yes)
|
8 Participants
|
|
Number of Subjects With Clinical Characteristics
The child had ever been breastfed (Yes)
|
150 Participants
|
|
Number of Subjects With Clinical Characteristics
The child had ever been breastfed (No)
|
41 Participants
|
|
Number of Subjects With Clinical Characteristics
The child was currently breastfed (Yes)
|
6 Participants
|
|
Number of Subjects With Clinical Characteristics
The child was currently breastfed (No)
|
144 Participants
|
|
Number of Subjects With Clinical Characteristics
Other children <6 years in the same household (0)
|
101 Participants
|
|
Number of Subjects With Clinical Characteristics
children <6 years in the same household (1-2)
|
87 Participants
|
|
Number of Subjects With Clinical Characteristics
children <6 years in the same household (≥3)
|
3 Participants
|
|
Number of Subjects With Clinical Characteristics
children ≥ 6 years in the same household (0)
|
134 Participants
|
|
Number of Subjects With Clinical Characteristics
children ≥ 6 years in the same household (1-2)
|
55 Participants
|
|
Number of Subjects With Clinical Characteristics
children ≥ 6 years in the same household (≥3)
|
2 Participants
|
|
Number of Subjects With Clinical Characteristics
Child at daycare &/school at least 2 day/week(Yes)
|
155 Participants
|
|
Number of Subjects With Clinical Characteristics
Child at day care &/school at least 2 day/week(No)
|
36 Participants
|
|
Number of Subjects With Clinical Characteristics
Child lived within 1 km of major polluters (Yes)
|
63 Participants
|
|
Number of Subjects With Clinical Characteristics
Child lived within 1 km of major polluters (No)
|
128 Participants
|
|
Number of Subjects With Clinical Characteristics
Major roadway (Yes)
|
20 Participants
|
|
Number of Subjects With Clinical Characteristics
Highway (Yes)
|
27 Participants
|
|
Number of Subjects With Clinical Characteristics
Area where trucks or vehicles were idle (Yes)
|
11 Participants
|
|
Number of Subjects With Clinical Characteristics
Major industry area with smokestacks (Yes)
|
13 Participants
|
|
Number of Subjects With Clinical Characteristics
Other (Yes)
|
6 Participants
|
|
Number of Subjects With Clinical Characteristics
Child with>3 day/week to cigarette smoke(Yes)
|
38 Participants
|
|
Number of Subjects With Clinical Characteristics
Child with>3 day/ week to cigarette smoked (No)
|
153 Participants
|
|
Number of Subjects With Clinical Characteristics
Previous episodes within the last year (0)
|
2 Participants
|
|
Number of Subjects With Clinical Characteristics
Previous episodes within the last year (1)
|
11 Participants
|
|
Number of Subjects With Clinical Characteristics
Previous episodes within the last year (2-3)
|
52 Participants
|
|
Number of Subjects With Clinical Characteristics
Previous episodes within the last year (4-5)
|
45 Participants
|
|
Number of Subjects With Clinical Characteristics
Previous episodes within the last year (6 or more)
|
73 Participants
|
|
Number of Subjects With Clinical Characteristics
Cough productive or wet (Yes)
|
153 Participants
|
|
Number of Subjects With Clinical Characteristics
Cough paroxysmal (Yes)
|
29 Participants
|
|
Number of Subjects With Clinical Characteristics
Cough laryngeal (Yes)
|
38 Participants
|
|
Number of Subjects With Clinical Characteristics
Shortness of breath independent of coughing (Yes)
|
35 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Laboratory results included blood sample results available, white blood Cell (WBC) count analysed, WBC reference range, Clinically relevant to the suspected chronic lower respiratory tract infection (LRTI) in the child if out of the range of WBC \[LRTI-WBC\], CRP (C-reactive protein) reference range, CRP groups, Clinically relevant to the suspected chronic LRTI in the child if out of the range of CRP \[LRTI-CRP\], ESR (Erythrocyte sedimentation rate) analysed, ESR reference range and Clinically relevant to the suspected chronic LRTI in the child if out of the range of ESR \[LRTI-ESR\].
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Laboratory Results
LRTI-ESR (No)
|
3 Participants
|
|
Number of Subjects With Laboratory Results
CRP reference range (missing range)
|
52 Participants
|
|
Number of Subjects With Laboratory Results
Blood sample results available (Yes)
|
109 Participants
|
|
Number of Subjects With Laboratory Results
WBC count analysed (Yes)
|
109 Participants
|
|
Number of Subjects With Laboratory Results
WBC reference range (low-high ranges)
|
78 Participants
|
|
Number of Subjects With Laboratory Results
WBC reference range (>high range)
|
31 Participants
|
|
Number of Subjects With Laboratory Results
LRTI-WBC (Yes)
|
18 Participants
|
|
Number of Subjects With Laboratory Results
LRTI-WBC (No)
|
17 Participants
|
|
Number of Subjects With Laboratory Results
CRP analysed (Yes)
|
57 Participants
|
|
Number of Subjects With Laboratory Results
CRP analysed (No)
|
52 Participants
|
|
Number of Subjects With Laboratory Results
CRP reference range (low-high ranges)
|
26 Participants
|
|
Number of Subjects With Laboratory Results
CRP reference range (>high range)
|
31 Participants
|
|
Number of Subjects With Laboratory Results
CRP groups <40 mg/L
|
46 Participants
|
|
Number of Subjects With Laboratory Results
CRP groups ≥40-80 mg/L
|
6 Participants
|
|
Number of Subjects With Laboratory Results
CRP groups ≥80-120 mg/L
|
3 Participants
|
|
Number of Subjects With Laboratory Results
CRP groups ≥120 mg/L
|
2 Participants
|
|
Number of Subjects With Laboratory Results
LRTI-CRP (Yes)
|
17 Participants
|
|
Number of Subjects With Laboratory Results
LRTI-CRP (No)
|
17 Participants
|
|
Number of Subjects With Laboratory Results
ESR analysed (Yes)
|
12 Participants
|
|
Number of Subjects With Laboratory Results
ESR analysed (No)
|
97 Participants
|
|
Number of Subjects With Laboratory Results
ESR reference range (low-high ranges)
|
8 Participants
|
|
Number of Subjects With Laboratory Results
ESR reference range (>high range)
|
4 Participants
|
|
Number of Subjects With Laboratory Results
ESR reference range (missing range)
|
97 Participants
|
|
Number of Subjects With Laboratory Results
LRTI-ESR (Yes)
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Laboratory results for WBC were expressed in 10\^9 cells per liter (10\^9 cells/L).
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
White Blood Cells (WBC) Laboratory Results
|
540.17 10^9 cells/L
Standard Deviation 2651.17
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Laboratory results for CRP were expressed in milligrams per litre (mg/L).
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
C-reactive Protein (CRP) Laboratory Results
|
25.45 mg/L
Standard Deviation 37.91
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Laboratory results for ESR were expressed in millimeters per hour (mm/hr).
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR) Laboratory Results
|
25.33 mm/hr
Standard Deviation 30.67
|
SECONDARY outcome
Timeframe: From Day 0 to Year 2Population: The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.
Radiological results included x-ray, result normality, relationship of abnormality to BAL sampling.
Outcome measures
| Measure |
Total Group
n=191 Participants
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
|
|---|---|
|
Number of Subjects With Radiological Results
Abnormality relevant to collecting the BALF (No)
|
21 Participants
|
|
Number of Subjects With Radiological Results
A Chest X-ray was done (Yes)
|
166 Participants
|
|
Number of Subjects With Radiological Results
A Chest X-ray was done (No)
|
25 Participants
|
|
Number of Subjects With Radiological Results
Result (Normal)
|
23 Participants
|
|
Number of Subjects With Radiological Results
Result (Abnormal)
|
143 Participants
|
|
Number of Subjects With Radiological Results
Abnormality relevant to collecting the BALF(Yes)
|
122 Participants
|
Adverse Events
Total Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place