Haemophilus Influenzae Pneumonia in Adults
- Conditions
- Haemophilus Influenzae Pneumonia
- Interventions
- Other: Collection of data from the patient's medical file
- Registration Number
- NCT06517277
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- Age < 18 years
- Opposition formulated (following receipt of the study information note)
- Legal protection measure (impossibility of collecting non-opposition)
- Ventilator-associated pneumonia (VAP)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Collection of data from the patient's medical file Hospitalized patients for a Haemophilus influenzae pneumonia in 13 AP-HP hospitals between 09/01/2022 to 08/31/2023.
- Primary Outcome Measures
Name Time Method Relapse associated factors of Haemophilus influenzae pneumonia 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.
- Secondary Outcome Measures
Name Time Method Pulmonary radiological patterns in Haemophilus influenzae pneumonia 15 months Describe the pulmonary radiological patterns associated with Haemophilus influenzae pneumonia.
Severity associated factors in Haemophilus influenzae pneumonia 15 months Identify the factors associated with severity in Haemophilus influenzae pneumonia. Severity is defined as: oxygen therapy \> 3 L/minute or need for hospitalization in intensive care unit or death.
Antibiotic resistance profiles of Haemophilus influenza strains 15 months Specify the antibiotic resistance profiles of the strains of Haemophilus influenzae responsible for pneumonia during the study period.
Trial Locations
- Locations (12)
Hôpital Béclère
🇫🇷Clamart, France
Hôpital du Kremlin-Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Hôpital Lariboisière
🇫🇷Paris, France
Hôpital Saint-Louis
🇫🇷Paris, France
Hôpital Beaujon
🇫🇷Clichy, France
Hôpital Raymond Poincaré
🇫🇷Garches, France
Hôpital Saint-Antoine
🇫🇷Paris, France
Hôpital La Pitié Salpêtrière
🇫🇷Paris, France
Hôpital Cochin
🇫🇷Paris, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hôpital Necker-Enfants Malades
🇫🇷Paris, France
Hôpital Bichat
🇫🇷Paris, France