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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 8
- 主要终点
- Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: BAL fluid sampling (Other)
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).
干预措施: Nasopharyngeal swab sampling (Other)
结局指标
主要结局
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
时间窗: From Day 0 up to Year 2
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
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
时间窗: From Day 0 up to Year 2
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.
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)
时间窗: From Day 0 up to Year 2
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.
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)
时间窗: From Day 0 up to Year 2
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
次要结局
- C-reactive Protein (CRP) Laboratory Results(From Day 0 to Year 2)
- Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples(From Day 0 up to Year 2)
- Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples(From Day 0 and up to Year 2)
- Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects(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(From Day 0 to Year 2)
- Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects(From Day 0 to Year 2)
- Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples(From Day 0 to Year 2)
- Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples(From Day 0 to Year 2)
- Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects(From Day 0 to Year 2)
- Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects(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(From Day 0 to Year 2)
- Erythrocyte Sedimentation Rate (ESR) Laboratory Results(From Day 0 to Year 2)
- 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 Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples(From Day 0 up to Year 2)
- Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects(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(From Day 0 to Year 2)
- Subject Gender(From Day 0 to Year 2)
- Number of Subjects Presenting General Medical History Characteristics(From Day 0 to Year 2)
- Mean Gestational Age of Subjects(From Day 0 to Year 2)
- Number of Subjects With Laboratory Results(From Day 0 to Year 2)
- Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, 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 Molecular Techniques (PCR) From Nasopharyngeal Swab Samples(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(From Day 0 to Year 2)
- Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples(From Day 0 to Year 2)
- Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects(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(From Day 0 to Year 2)
- Mean Age of Subjects(From Day 0 to Year 2)
- Number of Subjects With Body Mass Index (BMI) Characteristics(From Day 0 to Year 2)
- Number of Subjects With Pneumococcal Vaccination History Characteristics(From Day 0 to Year 2)
- White Blood Cells (WBC) Laboratory Results(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(From Day 0 to Year 2)
- Number of Subjects With Flu Vaccination History Characteristics(From Day 0 to Year 2)
- Number of Subjects With Antibiotics and Other Medications Administered(From Day 0 to Year 2)
- Number of Subjects With Clinical Characteristics(From Day 0 to Year 2)
- Number of Subjects With Radiological Results(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(From Day 0 to Year 2)
- Mean Weight of Subjects(From Day 0 to Year 2)
- Mean Height of Subjects(From Day 0 to Year 2)
- Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics(From Day 0 to Year 2)