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.

NCT02838407 | Completed Results

• 1 other identifier: 115813
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 7

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.

Conditions

Infections, Streptococcal

Keywords

Chronic lower respiratory tract infection; Bonchoalveolar lavage; Nasopharyngeal swabs

Outcome Measures

Primary Outcomes (4)

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

  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.

  From Day 0 up to Year 2

• Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples

  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

  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)

  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.

  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)

  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

  From Day 0 up to Year 2

Secondary Outcomes (40)

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

  From Day 0 up to Year 2

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

  From Day 0 up to Year 2

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

  From Day 0 up to Year 2

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

  From Day 0 up to Year 2

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

  From Day 0 up to Year 2

Study Arms (1)

Total group

OTHER

All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).

Other: BAL fluid sampling; Other: Nasopharyngeal swab sampling

Interventions

BAL fluid sampling OTHER

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

Total group

Nasopharyngeal swab sampling OTHER

1 swab, Day 0

Total group

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Barakaldo (Vizcaya), 48903, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Madrid, 28009, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Murcia (El Palmar), 30120, Spain

Location

GSK Investigational Site

Sabadell (Barcelona), 08208, Spain

Location

GSK Investigational Site

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 29285648 BACKGROUND

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 20, 2016
• Study Start: September 23, 2013
• Primary Completion: September 23, 2015
• Study Completion: September 23, 2015
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)