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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2015-23-09
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
Location
GSK Investigational Site
Valencia, Spain, 46010
Status
Study Complete

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
Completed
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