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Completed

NCT Number: NCT02838407

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.

The purpose of this study is to identify and characterise bacteria present in the lower airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is indicated by the clinician.

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site, Barakaldo (Vizcaya), Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who the investigator believes that parent(s)/ legally acceptable representatives (LAR[s]) can and will comply with the requirements of the protocol.
  • A male or female subject aged ≥ 6 months to < 6 years at the time of enrolment.
  • Subjects meet the case definition of suspected chronic LRTIs where BAL is indicated.
  • Subject's parent(s)/ LAR(s) agree to the collection of a nasopharyngeal swab from the subject.
  • Written informed consent obtained from the parent(s)/ LAR(s) of the subject.

Exclusion criteria

  • Known cystic fibrosis, immunosuppression, or other severe immunodeficiencies such as agammaglobu-linaemia, T cell deficiency or Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome, chemotherapy treatment, etc.
  • Exacerbation of persistent respiratory symptoms (cough, wheezing, difficulty in breathing, etc.) in the previous 2 weeks.
  • Antibiotic treatment in the 2 weeks prior to study entry.
  • Concurrent participation in another study within 30 days prior to study entry or at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Subjects having previously participated in this study.
  • Child in care.

Treatment and study plan

BAL fluid sampling

Other

Following routine BAL procedures at the hospital, collection of BAL fluid samples: at least 2 mL, at Day 0.

Nasopharyngeal swab sampling

Other

1 swab, Day 0

Primary outcomes

  1. Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples

    Time frame: From Day 0 up to Year 2

    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.

  2. Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples

    Time frame: From Day 0 up to Year 2

    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

  3. 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)

    Time frame: From Day 0 up to Year 2

    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.

  4. 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)

    Time frame: From Day 0 up to Year 2

    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

Secondary outcomes

  1. Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples

    Time frame: From Day 0 up to Year 2

    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.).

  2. Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples

    Time frame: From Day 0 up to Year 2

    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.

  3. Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples

    Time frame: From Day 0 up to Year 2

    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.

  4. Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples

    Time frame: From Day 0 up to Year 2

    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.

  5. Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples

    Time frame: From Day 0 up to Year 2

    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.

  6. Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples

    Time frame: From Day 0 and up to Year 2

    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.

  7. Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples

    Time frame: From Day 0 and up to Year 2

    Bacterial pathogens were detected by qualitative culture from nasopharyngeal swab samples and included: Staphylococcus aureus and Stenotrophomonas maltophilia

  8. Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples

    Time frame: From Day 0 to Year 2

    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.

  9. Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples

    Time frame: From Day 0 to Year 2

    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.

  10. Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples

    Time frame: From Day 0 to Year 2

    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.

  11. Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples

    Time frame: From Day 0 to Year 2

    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.

  12. Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects

    Time frame: From Day 0 to Year 2

    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.

  13. Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects

    Time frame: From Day 0 to Year 2

    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.

  14. Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin

    Time frame: From Day 0 to Year 2

    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.

  15. Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects

    Time frame: From Day 0 to Year 2

    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.

  16. Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin

    Time frame: From Day 0 to Year 2

    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.

  17. Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase

    Time frame: From Day 0 to Year 2

    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.

  18. Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects

    Time frame: From Day 0 to Year 2

    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.

  19. Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects

    Time frame: From Day 0 to Year 2

    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.

  20. Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin

    Time frame: From Day 0 to Year 2

    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.

  21. Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects

    Time frame: From Day 0 to Year 2

    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.

  22. Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin

    Time frame: From Day 0 to Year 2

    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.

  23. Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase

    Time frame: From Day 0 to Year 2

    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.

  24. Mean Age of Subjects

    Time frame: From Day 0 to Year 2

    Demographic characteristics included age, which was expressed in months.

  25. Subject Gender

    Time frame: From Day 0 to Year 2

    Demographic characteristics included gender: female and male.

  26. Mean Weight of Subjects

    Time frame: From Day 0 to Year 2

    Demographic characteristics included weight which was expressed in kilograms (kg).

  27. Mean Height of Subjects

    Time frame: From Day 0 to Year 2

    Demographic characteristics included height which was expressed in centimeters (cm).

  28. Number of Subjects With Body Mass Index (BMI) Characteristics

    Time frame: From Day 0 to Year 2

    Demographic characteristics included body mass index (BMI) whose z-scores were measures of relative weight adjusted for child age and sex.

  29. Number of Subjects Presenting General Medical History Characteristics

    Time frame: From Day 0 to Year 2

    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.

  30. Mean Gestational Age of Subjects

    Time frame: From Day 0 to Year 2

    General medical history included mean gestational age.

  31. Number of Subjects With Pneumococcal Vaccination History Characteristics

    Time frame: From Day 0 to Year 2

    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.

  32. Number of Subjects With Flu Vaccination History Characteristics

    Time frame: From Day 0 to Year 2

    Flu vaccination history included vaccination, Flu vaccine doses (1-5), medical history source validated or not.

  33. Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics

    Time frame: From Day 0 to Year 2

    Haemophilus influenzae type b vaccination history included vaccination, Haemophilus influenzae type b vaccine doses (1-4), medical history source validated or not.

  34. Number of Subjects With Antibiotics and Other Medications Administered

    Time frame: From Day 0 to Year 2

    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.

  35. Number of Subjects With Clinical Characteristics

    Time frame: From Day 0 to Year 2

    Clinical characteristics included affections/pre-conditions, affection episodes, number of children living in a household, children in day-care centres, exposure to cigarette smoke.

  36. Number of Subjects With Laboratory Results

    Time frame: From Day 0 to Year 2

    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].

  37. White Blood Cells (WBC) Laboratory Results

    Time frame: From Day 0 to Year 2

    Laboratory results for WBC were expressed in 10^9 cells per liter (10^9 cells/L).

  38. C-reactive Protein (CRP) Laboratory Results

    Time frame: From Day 0 to Year 2

    Laboratory results for CRP were expressed in milligrams per litre (mg/L).

  39. Erythrocyte Sedimentation Rate (ESR) Laboratory Results

    Time frame: From Day 0 to Year 2

    Laboratory results for ESR were expressed in millimeters per hour (mm/hr).

  40. Number of Subjects With Radiological Results

    Time frame: From Day 0 to Year 2

    Radiological results included x-ray, result normality, relationship of abnormality to BAL sampling.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Identification and Characterization of Bacteria in the Lower Airways of Children Aged ≥ 6 Months to < 6 Years With Suspected Lower Respiratory Tract Infections (LRTI) in Spain.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2016
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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