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临床试验/NCT06517277
NCT06517277已完成不适用

Retrospective Hospital Study of Haemophilus Influenzae Pneumonia in Adults: Relapse and Severity

Assistance Publique - Hôpitaux de Paris12 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2024年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
12
主要终点
Relapse associated factors of Haemophilus influenzae pneumonia

研究概览

简要总结

Haemophilus influenzae is a Gram-negative coccobacillus capable of colonizing and infecting the human respiratory tract.

In the adult population, patients with an abnormality of their mucociliary epithelium and a deficiency in innate or adaptive immunity are particularly exposed.

The Infectious and Tropical Diseases department of Necker-Enfants Malades hospital has noted a recent increase in the number of cases of respiratory infections due to H. influenzae, with a high frequency of early relapses and recurrences despite appropriate treatment.

The research focuses on lower respiratory infections (pneumonia) caused by Haemophilus influenzae in adults, excluding pneumonia acquired under mechanical ventilation linked to Haemophilus influenzae in patients in 13 AP-HP hospitals during 12 months, from 09/01/2022 to 08/31/2023.

详细描述

Haemophilus influenzae is a Gram-negative coccobacillus capable of colonizing and infecting the human respiratory tract.

In the adult population, patients with an abnormality of their mucociliary epithelium and a deficiency in innate or adaptive immunity are particularly exposed.

The Infectious and Tropical Diseases department of Necker-Enfants Malades hospital has noted a recent increase in the number of cases of respiratory infections due to H. influenzae, with a high frequency of early relapses and recurrences despite appropriate treatment.

The research focuses on lower respiratory infections (pneumonia) caused by Haemophilus influenzae in adults, excluding pneumonia acquired under mechanical ventilation linked to Haemophilus influenzae in patients in 13 AP-HP hospitals during 12 months, from 09/01/2022 to 08/31/2023.

The main objective of the study is to identify factors associated with relapse in hospitalized adult Haemophilus influenzae pneumonia.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute respiratory symptoms: cough and/or dyspnea and/or purulent sputum or worsening of the color of the sputum for patients with chronic respiratory pathology, chest pain, desaturation defined by saturation < 95% in ambient air
  • Inflammatory syndrome: fever ≥ 38.5°C or CRP ≥ 30 mg/L
  • Pulmonary imaging (x-ray or CT scan) compatible with pneumonia
  • Good quality respiratory sample (for cytobacteriological examination of sputum (CBES) : leukocytes > 25/mm3 and cells < 10/mm3) positive in culture for H. influenzae at a significant threshold (for CBES ≥ 107 CFU/mL, for "standard" bronchial aspirate ≥ 105 CFU/mL, for protected bronchial aspiration ≥ 103 CFU/mL, for bronchoalveolar lavage ≥ 104 CFU/mL)
  • Respiratory antibiotic therapy started by the clinician

排除标准

  • Age < 18 years
  • Opposition formulated (following receipt of the study information note)
  • Legal protection measure (impossibility of collecting non-opposition)
  • Ventilator-associated pneumonia (VAP)

结局指标

主要结局

Relapse associated factors of Haemophilus influenzae pneumonia

时间窗: 15 months

Relapse associated factors with the Haemophilus influenzae pneumonia in hospitalized adult. Relapse of Haemophilus influenzae pneumonia defined as: * Definite relapse: acute respiratory symptoms (cough and/or dyspnea and/or purulent sputum), inflammatory syndrome (clinical: fever ≥ 38.5°C or biological: CRP ≥ 30 mg/L), respiratory antibiotic therapy started by the clinician, new good quality respiratory sample positive in culture for Haemophilus influenzae within 90 days following the first episode. * Probable relapse: acute respiratory symptoms, inflammatory syndrome (clinical: fever ≥ 38.5°C or biological: CRP ≥ 30 mg/L), respiratory antibiotic therapy started by the clinician, absence of microbiological documentation of the new episode, within 30 days following the first episode.

次要结局

  • Pulmonary radiological patterns in Haemophilus influenzae pneumonia(15 months)
  • Severity associated factors in Haemophilus influenzae pneumonia(15 months)
  • Antibiotic resistance profiles of Haemophilus influenza strains(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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