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.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-23

Study Completion Date

2015-09-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Infections, Streptococcal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Total group

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).

Group Type OTHER

BAL fluid sampling

Intervention Type OTHER

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

Nasopharyngeal swab sampling

Intervention Type OTHER

1 swab, Day 0

Interventions

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BAL fluid sampling

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

Intervention Type OTHER

Nasopharyngeal swab sampling

1 swab, Day 0

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No