Clinical trial 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.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections, Streptococcal
Keywords: Chronic lower respiratory tract infection
Bonchoalveolar lavage
Nasopharyngeal swabs
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-07-20
Enrollment: 197
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Primary outcomes:
measure: Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
timeFrame: From Day 0 up to Year 2
measure: Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
timeFrame: From Day 0 up to Year 2
measure: 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)
timeFrame: From Day 0 up to Year 2
measure: 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)
timeFrame: From Day 0 up to Year 2
Secondary outcomes:
measure: Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
timeFrame: From Day 0 up to Year 2
measure: Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples
timeFrame: From Day 0 up to Year 2
measure: Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples
timeFrame: From Day 0 up to Year 2
measure: Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
timeFrame: From Day 0 up to Year 2
measure: Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples
timeFrame: From Day 0 up to Year 2
measure: Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples
timeFrame: From Day 0 and up to Year 2
measure: Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples
timeFrame: From Day 0 and up to Year 2
measure: Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
timeFrame: From Day 0 to Year 2
measure: Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples
timeFrame: From Day 0 to Year 2
measure: Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
timeFrame: From Day 0 to Year 2
measure: Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples
timeFrame: From Day 0 to Year 2
measure: Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
timeFrame: From Day 0 to Year 2
measure: Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
timeFrame: From Day 0 to Year 2
measure: Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
timeFrame: From Day 0 to Year 2
measure: Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
timeFrame: From Day 0 to Year 2
measure: Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin
timeFrame: From Day 0 to Year 2
measure: Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
timeFrame: From Day 0 to Year 2
measure: Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
timeFrame: From Day 0 to Year 2
measure: Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
timeFrame: From Day 0 to Year 2
measure: Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
timeFrame: From Day 0 to Year 2
measure: Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
timeFrame: From Day 0 to Year 2
measure: Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin
timeFrame: From Day 0 to Year 2
measure: Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
timeFrame: From Day 0 to Year 2
measure: Mean Age of Subjects
timeFrame: From Day 0 to Year 2
measure: Subject Gender
timeFrame: From Day 0 to Year 2
measure: Mean Weight of Subjects
timeFrame: From Day 0 to Year 2
measure: Mean Height of Subjects
timeFrame: From Day 0 to Year 2
measure: Number of Subjects With Body Mass Index (BMI) Characteristics
timeFrame: From Day 0 to Year 2
measure: Number of Subjects Presenting General Medical History Characteristics
timeFrame: From Day 0 to Year 2
measure: Mean Gestational Age of Subjects
timeFrame: From Day 0 to Year 2
measure: Number of Subjects With Pneumococcal Vaccination History Characteristics
timeFrame: From Day 0 to Year 2
measure: Number of Subjects With Flu Vaccination History Characteristics
timeFrame: From Day 0 to Year 2
measure: Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
timeFrame: From Day 0 to Year 2
measure: Number of Subjects With Antibiotics and Other Medications Administered
timeFrame: From Day 0 to Year 2
measure: Number of Subjects With Clinical Characteristics
timeFrame: From Day 0 to Year 2
measure: Number of Subjects With Laboratory Results
timeFrame: From Day 0 to Year 2
measure: White Blood Cells (WBC) Laboratory Results
timeFrame: From Day 0 to Year 2
measure: C-reactive Protein (CRP) Laboratory Results
timeFrame: From Day 0 to Year 2
measure: Erythrocyte Sedimentation Rate (ESR) Laboratory Results
timeFrame: From Day 0 to Year 2
measure: Number of Subjects With Radiological Results
timeFrame: From Day 0 to Year 2
Other outcomes:
Locations:
city: Barakaldo (Vizcaya)
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Murcia (El Palmar)
country: Spain
facility: GSK Investigational Site
city: Sabadell (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Escribano Montaner A, Garcia de Lomas J, Villa Asensi JR, Asensio de la Cruz O, de la Serna Blazquez O, Santiago Burruchaga M, Mondejar Lopez P, Torrent Vernetta A, Feng Y, Van Dyke MK, Reyes J, Garcia-Corbeira P, Talarico CA; EPI-Strep-064 study group. Bacteria from bronchoalveolar lavage fluid from children with suspected chronic lower respiratory tract infection: results from a multi-center, cross-sectional study in Spain. Eur J Pediatr. 2018 Feb;177(2):181-192. doi: 10.1007/s00431-017-3044-3. Epub 2017 Dec 29.