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.

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Streptococcal

Treatments: Other: BAL fluid sampling; Other: Nasopharyngeal swab sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT02838407

115813

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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197 participants in 1 patient group

Total group

Other group

Description:

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).

Treatment:

Other: BAL fluid sampling

Other: Nasopharyngeal swab sampling