Last updated: 09/06/2019 12:50:09

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.

GSK study ID
115813
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of subjects with bacterial aetiology, assessed by culture growth, from bronchoalveolar lavage (BAL) fluid samples

Timeframe: From Day 0 up to Year 2

Number of subjects with bacterial aetiology characteristics in BAL fluid samples

Timeframe: From Day 0 up to Year 2

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

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:

Number of subjects with bacterial colonization, assessed by culture growth, from nasopharyngeal swab samples

Timeframe: From Day 0 up to Year 2

Bacterial load detected (log10 transformation) by quantitative culture growth, from BAL fluid samples

Timeframe: From Day 0 up to Year 2

Bacterial load detected (log10 transformation) by quantitative molecular techniques (Polymerase Chain Reaction) from BAL fluid samples

Timeframe: From Day 0 up to Year 2

Number of subjects with other bacterial pathogens detected by qualitative culture, from BAL fluid samples

Timeframe: From Day 0 up to Year 2

Bacterial load detected (log10 transformation) by quantitative culture from nasopharyngeal swab samples

Timeframe: From Day 0 up to Year 2

Bacterial load detected (log10 transformation) by molecular techniques (PCR) from nasopharyngeal swab samples

Timeframe: From Day 0 and up to Year 2

Number of subjects with other bacterial pathogens detected by qualitative culture from nasopharyngeal swab samples

Timeframe: From Day 0 and up to Year 2

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

Number of qualitative positive unique isolates of subjects with H. influenzae typing results from BAL fluid samples

Timeframe: From Day 0 to Year 2

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

Number of qualitative positive unique isolates of subjects with H. influenzae typing results from nasopharyngeal swab samples

Timeframe: From Day 0 to Year 2

Number of S. pneumoniae unique isolates with antimicrobial susceptibility response, among qualitative positive subjects

Timeframe: From Day 0 to Year 2

Number of H. influenzae unique isolates with antimicrobial susceptibility response, among qualitative positive subjects

Timeframe: From Day 0 to Year 2

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

Number of M. catarrhalis unique isolates with antimicrobial susceptibility response, among qualitative positive subjects

Timeframe: From Day 0 to Year 2

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

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

Number of S. pneumoniae unique isolates with antimicrobial susceptibility response from quantitative positive subjects

Timeframe: From Day 0 to Year 2

Number of H. influenzae unique isolates with antimicrobial susceptibility response from quantitative positive subjects

Timeframe: From Day 0 to Year 2

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

Number of M. catarrhalis unique isolates with antimicrobial susceptibility response from quantitative positive subjects

Timeframe: From Day 0 to Year 2

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

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

Mean age of subjects

Timeframe: From Day 0 to Year 2

Subject gender

Timeframe: From Day 0 to Year 2

Mean weight of subjects

Timeframe: From Day 0 to Year 2

Mean height of subjects

Timeframe: From Day 0 to Year 2

Number of subjects with body mass index (BMI) characteristics

Timeframe: From Day 0 to Year 2

Number of subjects presenting general medical history characteristics

Timeframe: From Day 0 to Year 2

Mean gestational age of subjects

Timeframe: From Day 0 to Year 2

Number of subjects with Pneumococcal Vaccination history characteristics

Timeframe: From Day 0 to Year 2

Number of subjects with Flu vaccination history characteristics

Timeframe: From Day 0 to Year 2

Number of subjects with Haemophilus influenzae type b vaccination history characteristics

Timeframe: From Day 0 to Year 2

Number of subjects with antibiotics and other medications administered

Timeframe: From Day 0 to Year 2

Number of subjects with clinical characteristics

Timeframe: From Day 0 to Year 2

Number of subjects with laboratory results

Timeframe: From Day 0 to Year 2

White Blood Cells (WBC) laboratory results

Timeframe: From Day 0 to Year 2

C-reactive protein (CRP) laboratory results

Timeframe: From Day 0 to Year 2

Erythrocyte sedimentation rate (ESR) laboratory results

Timeframe: From Day 0 to Year 2

Number of subjects with radiological results

Timeframe: From Day 0 to Year 2

Interventions:
  • Other: BAL fluid sampling
  • Other: Nasopharyngeal swab sampling
  • Enrollment:
    197
    Primary completion date:
    2015-23-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Escribano Montaner A et al. (2018) 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. 177(2):181-192.
    Medical condition
    Infections, Streptococcal
    Product
    GSK2647154A
    Collaborators
    Not applicable
    Study date(s)
    September 2013 to September 2015
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    6 months - 6 years
    Accepts healthy volunteers
    No
    • 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.
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Barakaldo (Vizcaya), Spain, 48903
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08035
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28009
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28046
    Status
    Study Complete
    Location
    GSK Investigational Site
    Murcia (El Palmar), Spain, 30120
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sabadell (Barcelona), Spain, 08208
    Status
    Study Complete
    Showing 1 - 6 of 7 Results

    Study documents

    Statistical analysis plan
    Available language(s): English
    Scientific result summary
    Available language(s): English
    Protocol
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2015-23-09
    Actual study completion date
    2015-23-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website