N/A
N=197
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.
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT02838407 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples — 141; 49; 1; 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BAL fluid sampling (Other); Nasopharyngeal swab sampling (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples |
141; 49; 1; 58; 132; 1 | — |
| PRIMARY Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples |
15; 14; 6; 12; 10; 1 | — |
| PRIMARY 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) |
148; 14; 15; 1 | — |
| PRIMARY 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) |
6; 2; 4; 0 | — |
| SECONDARY Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples |
154; 37; 99; 92; 89; 102 | — |
| SECONDARY Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples |
4.28; 3.81; 3.54 | — |
| SECONDARY Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples |
4.06; 4.31; 3.92 | — |
| SECONDARY Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples |
1; 5; 4; 2 | — |
| SECONDARY Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples |
3.99; 3.61; 3.36 | — |
| SECONDARY Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples |
4.39; 4.16; 4.05 | — |
| SECONDARY Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples |
6; 1 | — |
| SECONDARY Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples |
2; 4; 1; 3; 1; 4 | — |
| SECONDARY Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples |
3; 95 | — |
| SECONDARY Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples |
2; 1; 6; 2; 1; 5 | — |
| SECONDARY Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples |
4; 88 | — |
| SECONDARY Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects |
36; 13; 16; 55; 27; 23 | — |
| SECONDARY Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects |
91; 0; 7; 91; 0; 1 | — |
| SECONDARY Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin |
0.5; 0.5; 4; 4.00 | — |
| SECONDARY Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects |
95; 0; 3; 105; 0; 5 | — |
| SECONDARY Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin |
8.00; 16.00 | — |
| SECONDARY Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase |
7; 9; 93; 108 | — |
| SECONDARY Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects |
15; 2; 4; 11; 10; 5 | — |
| SECONDARY Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects |
15; 0; 3; 8; 0; 0 | — |
| SECONDARY Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin |
0.50; 0.5; 4.00; 4.00 | — |
| SECONDARY Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects |
12; 0; 1; 9; 0; 1 | — |
| SECONDARY Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin |
16.00; 16.00 | — |
| SECONDARY Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase |
3; 1; 13; 10 | — |
| SECONDARY Mean Age of Subjects |
39.84 | — |
| SECONDARY Subject Gender |
92; 99 | — |
| SECONDARY Mean Weight of Subjects |
14.67 | — |
| SECONDARY Mean Height of Subjects |
96.04 | — |
| SECONDARY Number of Subjects With Body Mass Index (BMI) Characteristics |
5; 9; 122; 26; 14; 4 | — |
| SECONDARY Number of Subjects Presenting General Medical History Characteristics |
176; 15; 2; 33; 18; 1 | — |
| SECONDARY Mean Gestational Age of Subjects |
33.00 | — |
| SECONDARY Number of Subjects With Pneumococcal Vaccination History Characteristics |
168; 15; 123; 1; 29; 2 | — |
| SECONDARY Number of Subjects With Flu Vaccination History Characteristics |
58; 18; 26; 6; 5; 3 | — |
| SECONDARY Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics |
188; 2; 4; 38; 144; 184 | — |
| SECONDARY Number of Subjects With Antibiotics and Other Medications Administered |
153; 83; 76; 24; 1; 57 | — |
| SECONDARY Number of Subjects With Clinical Characteristics |
151; 86; 74; 131; 63; 8 | — |
| SECONDARY Number of Subjects With Laboratory Results |
109; 109; 78; 31; 18; 17 | — |
| SECONDARY White Blood Cells (WBC) Laboratory Results |
540.17 | — |
| SECONDARY C-reactive Protein (CRP) Laboratory Results |
25.45 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) Laboratory Results |
25.33 | — |
| SECONDARY Number of Subjects With Radiological Results |
166; 25; 23; 143; 122; 21 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02838407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.